Trial Outcomes & Findings for Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine (NCT NCT02068729)

NCT ID: NCT02068729

Last Updated: 2021-04-05

Results Overview

Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain.

Recruitment status

TERMINATED

Target enrollment

131 participants

Primary outcome timeframe

24 months

Results posted on

2021-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	K2M RAVINE Lateral Access System This treatment group included patients treated with the RAVINE system that had: 1. A diagnosis of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1, confirmed clinically and radiographically, required surgical intervention. 2. One or two contiguous levels that required surgical intervention. 3. Inadequately responded to conservative medical care over a period of at least 6 months. 4. An age at time of enrollment greater or equal to 18 years old.
Overall Study STARTED	131
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	75

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The study Case Report Forms did not include Race/Ethnicity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Demographics and Baseline Characteristics n=125 Participants This is a demographic and baseline characteristics of the patient population. This includes parameters such as Age, Gender, Height, Weight Body Mass Index (BMI) and Tobacco Usage.
Age, Categorical <=18 years	0 Participants n=125 Participants
Age, Categorical Between 18 and 65 years	77 Participants n=125 Participants
Age, Categorical >=65 years	48 Participants n=125 Participants
Age, Continuous	61.8 years STANDARD_DEVIATION 9.7 • n=125 Participants
Sex: Female, Male Female	78 Participants n=125 Participants
Sex: Female, Male Male	47 Participants n=125 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) Asian	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) Black or African American	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) White	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) More than one race	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) Unknown or Not Reported	0 Participants The study Case Report Forms did not include Race/Ethnicity
Region of Enrollment United States	125 Participants n=125 Participants
Body Mass Index (BMI)	28.48 lbs/(in^2)*703 STANDARD_DEVIATION 4.4 • n=125 Participants
Height	65.96 inches STANDARD_DEVIATION 3.9 • n=125 Participants
Weight	177.2 pounds STANDARD_DEVIATION 36.7 • n=125 Participants
Tobacco Use Never	63 Participants n=125 Participants
Tobacco Use Quit	43 Participants n=125 Participants
Tobacco Use Currently Use	19 Participants n=125 Participants
Tobacco Use Missing	0 Participants n=125 Participants

PRIMARY outcome

Timeframe: 24 months

Population: All patients were accounted for

Outcome measures

Outcome measures
Measure	Back n=56 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=56 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=56 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg n=56 Participants Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg n=56 Participants Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Visual Analog Scale (VAS) Change From Baseline	-4.3 score on a scale Standard Deviation 3.7	-2.3 score on a scale Standard Deviation 3.8	-4.0 score on a scale Standard Deviation 3.7	-2.1 score on a scale Standard Deviation 3.4	-3.5 score on a scale Standard Deviation 4	—

PRIMARY outcome

Timeframe: Operative to 24 month

Population: This is an analysis of the number of participants that reported any form of adverse event. Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events. 9 of the 30 SAE participants did not experience a non-SAE events. The other 21 participants had events in both categories

The evaluation of all adverse events including device related, procedure related and additional serious adverse events.

Outcome measures

Outcome measures
Measure	Back n=125 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=125 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=125 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg n=125 Participants Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg n=125 Participants Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall n=125 Participants Overall number of Patients with Adverse Events
Number of Patients With Adverse Events AEs) Any SAE : Severe	5 participants	3 participants	2 participants	5 participants	6 participants	18 participants
Number of Patients With Adverse Events AEs) Any AE	45 participants	16 participants	22 participants	33 participants	23 participants	82 participants
Number of Patients With Adverse Events AEs) Any AE : Procedure Related	23 participants	3 participants	4 participants	6 participants	4 participants	34 participants
Number of Patients With Adverse Events AEs) Any AE : Device Related	4 participants	2 participants	3 participants	2 participants	2 participants	10 participants
Number of Patients With Adverse Events AEs) Any AE : Mild	28 participants	7 participants	7 participants	19 participants	9 participants	51 participants
Number of Patients With Adverse Events AEs) Any AE : Moderate	21 participants	7 participants	15 participants	12 participants	14 participants	52 participants
Number of Patients With Adverse Events AEs) Any AE : Severe	5 participants	4 participants	3 participants	5 participants	6 participants	20 participants
Number of Patients With Adverse Events AEs) Any Serious Adverse Event (SAE)	10 participants	4 participants	3 participants	7 participants	10 participants	30 participants
Number of Patients With Adverse Events AEs) Any SAE : Procedure Related	4 participants	0 participants	0 participants	1 participants	1 participants	6 participants
Number of Patients With Adverse Events AEs) Any SAE : Device Related	1 participants	1 participants	0 participants	0 participants	1 participants	2 participants
Number of Patients With Adverse Events AEs) Any SAE : Mild	3 participants	0 participants	0 participants	1 participants	2 participants	6 participants
Number of Patients With Adverse Events AEs) Any SAE : Moderate	4 participants	1 participants	1 participants	1 participants	3 participants	10 participants

SECONDARY outcome

Timeframe: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

Population: The overall number of patients participated in each interval differed from the number of patients that were evaluated for the body location measurements.

Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness was performed using Patient symptom Questionnaire (0-100mm analog scale with 100mm being the highest pain/weakness/numbness)

Outcome measures

Outcome measures
Measure	Back n=92 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=117 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=107 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg n=103 Participants Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg n=93 Participants Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall n=56 Participants Overall number of Patients with Adverse Events
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Right Hip Cross Leg Weakness	6.1 score on a scale Standard Deviation 37.1	-13.4 score on a scale Standard Deviation 39.0	-21.6 score on a scale Standard Deviation 36.5	-25.2 score on a scale Standard Deviation 35.8	-27.8 score on a scale Standard Deviation 32.4	-25.6 score on a scale Standard Deviation 32.8
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Pain Above Left Knee	-3.9 score on a scale Standard Deviation 28.6	-14.3 score on a scale Standard Deviation 38.2	-20 score on a scale Standard Deviation 34.3	-18.7 score on a scale Standard Deviation 33.8	-22.4 score on a scale Standard Deviation 34.6	-17.8 score on a scale Standard Deviation 34
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Pain Above Right Knee	-15.3 score on a scale Standard Deviation 33.8	-21.3 score on a scale Standard Deviation 35.8	-26.9 score on a scale Standard Deviation 33.9	-29.2 score on a scale Standard Deviation 33.9	-31 score on a scale Standard Deviation 31.4	-31.2 score on a scale Standard Deviation 31.8
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Left Groin Pain	-0.3 score on a scale Standard Deviation 28.3	-10.4 score on a scale Standard Deviation 33.5	-11.8 score on a scale Standard Deviation 30.8	-14.5 score on a scale Standard Deviation 28.7	-15.1 score on a scale Standard Deviation 31.1	-10.8 score on a scale Standard Deviation 25.2
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Right Groin Pain	-7.2 score on a scale Standard Deviation 29.9	-15.1 score on a scale Standard Deviation 33.4	-15.7 score on a scale Standard Deviation 31.6	-19.9 score on a scale Standard Deviation 33.1	-20.3 score on a scale Standard Deviation 31	-23.2 score on a scale Standard Deviation 30.5
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Flexing Left Hip Weakness	7.8 score on a scale Standard Deviation 37.9	-10.6 score on a scale Standard Deviation 39.7	-15.1 score on a scale Standard Deviation 33.3	-17.8 score on a scale Standard Deviation 33.2	-20.0 score on a scale Standard Deviation 32.2	-12.5 score on a scale Standard Deviation 29.2
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Flexing Right Hip Weakness	-0.3 score on a scale Standard Deviation 34.1	-17.3 score on a scale Standard Deviation 34.7	-17.6 score on a scale Standard Deviation 34.0	-23.5 score on a scale Standard Deviation 33.8	-24.7 score on a scale Standard Deviation 31.7	-20.4 score on a scale Standard Deviation 34.1
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Extending Left Hip Weakness	8.6 score on a scale Standard Deviation 39.7	-7.4 score on a scale Standard Deviation 40.1	-14.0 score on a scale Standard Deviation 30.1	-16.9 score on a scale Standard Deviation 30.7	-16.8 score on a scale Standard Deviation 33.4	-11.0 score on a scale Standard Deviation 30.6
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Extending Right Hip Weakness	-2.8 score on a scale Standard Deviation 33.1	-15.6 score on a scale Standard Deviation 36.2	-16.2 score on a scale Standard Deviation 36.5	-24.4 score on a scale Standard Deviation 32.3	-24.4 score on a scale Standard Deviation 33.1	-22.4 score on a scale Standard Deviation 34.9
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Left Hip Stairs Weakness	6.1 score on a scale Standard Deviation 38	-15.9 score on a scale Standard Deviation 42.5	-20.5 score on a scale Standard Deviation 38.9	-24.7 score on a scale Standard Deviation 36.8	-26.8 score on a scale Standard Deviation 36.6	-20.0 score on a scale Standard Deviation 33.7
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Right Hip Stairs Weakness	0.4 score on a scale Standard Deviation 36.2	-20.7 score on a scale Standard Deviation 39.6	-24.3 score on a scale Standard Deviation 37.7	-29.7 score on a scale Standard Deviation 36.4	-30.1 score on a scale Standard Deviation 35.2	-27.8 score on a scale Standard Deviation 35.5
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) Left Hip Cross Leg Weakness	16.8 score on a scale Standard Deviation 41.1	-8.2 score on a scale Standard Deviation 42.7	-16.7 score on a scale Standard Deviation 40.1	-21.0 score on a scale Standard Deviation 34.7	-25.5 score on a scale Standard Deviation 36.3	-19.2 score on a scale Standard Deviation 31.8

SECONDARY outcome

Timeframe: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

Population: 131 patients started the study at Pre-op, 6 patients did not complete the survey; 125 started operative, 34 patients did not complete the survey at Discharge; 121 started the Post-operative interval, 4 patients did not complete the survey; 111 patients started at 3 Month interval, 4 patients did not complete the survey; All patients who started at 6 months and 24 months completed their surveys at their respective intervals.

The Oswestry Disability Index (ODI) is a validated instrument including items that relate to subjective symptomatology and activities of daily living (pain intensity, personal care, lifting, walking, sitting, standing, sex life, traveling). This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from O up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.

Outcome measures

Outcome measures
Measure	Back n=91 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=117 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=107 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg n=104 Participants Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg n=93 Participants Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall n=56 Participants Overall number of Patients with Adverse Events
Change in Oswestry Disability Index From Baseline (Pre-Operative)	7.7 score on a scale Standard Deviation 19.5	-10.1 score on a scale Standard Deviation 21.1	-17.3 score on a scale Standard Deviation 18.5	-22.7 score on a scale Standard Deviation 19	-26.9 score on a scale Standard Deviation 17.5	-24.3 score on a scale Standard Deviation 17.6

SECONDARY outcome

Timeframe: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

Population: The number analyzed in Mental Health and Physical Health rows for 6 Months and 12 Months differ due to the inability for a participant to complete the required forms for those two intervals.

Health-related quality of life was evaluated in all study subjects using the SF-12v2 Health Survey. This shortened and simplified version of the SF-36 makes the questionnaire less ambiguous for patients. It has a self-administered form that makes it easy to read and complete, and that reduces missing responses. The physical and mental component summary scales, referred to as PCS-12 and MCS-12 were evaluated against published normative values and a 15% improvement in these scores was used as an assessment of success. In calculating the true value of a treatment, the scores from the SF-12v2 were converted into a utility index (SF-6D), which considered not only how many years a medical intervention could have added to a patient's life, but also the quality of that life. Use of the SF-6D did not expand the questions administered to the patients. The scale ranged from 0-100% with 100% being the best quality of life.

Outcome measures

Outcome measures
Measure	Back n=91 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=117 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=106 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg n=104 Participants Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg n=92 Participants Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall n=56 Participants Overall number of Patients with Adverse Events
Change in Health-Related Quality of Life From Baseline (Pre-op) Mental Health	0.01 score on a scale Standard Deviation 10	4.0 score on a scale Standard Deviation 12.4	4.8 score on a scale Standard Deviation 11.6	7.6 score on a scale Standard Deviation 12.7	7.6 score on a scale Standard Deviation 10.7	7.1 score on a scale Standard Deviation 11.9
Change in Health-Related Quality of Life From Baseline (Pre-op) Physical Health	0.6 score on a scale Standard Deviation 6.8	4.6 score on a scale Standard Deviation 9.3	8.2 score on a scale Standard Deviation 9.2	9.7 score on a scale Standard Deviation 11.5	12.9 score on a scale Standard Deviation 9	11.5 score on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: 12 mo to 24 mo

Population: The numbers are different from the overall number analyzed due to the different number of people who participated in each visit's radiographic analysis

Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images were performed. Radiographic and qualitative assessments performed include: * Device Condition: looks at both the cage inside the vertebrae and the hardware outside the vertebrae. It looks at whether or not the device is intact or not (subsidence or migration) * Fusion/Non-fusion: whether bone has grown within the space between the spinal vertebrae. If fusion occurs, it results in Bony Bridging

Outcome measures

Outcome measures
Measure	Back n=95 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=23 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=23 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Radiographic Assessments 12 Month Fusion · Absent	2 Participants	3 Participants	3 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Partial Consolidation	10 Participants	2 Participants	2 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Bridging / Fusion	33 Participants	11 Participants	11 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Intact	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Loosening	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Fracture	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Not Applicable	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Unable to Assess	15 Participants	2 Participants	2 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Subsidence	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Subsidence & Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Fusion · Other	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Absent	0 Participants	1 Participants	1 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Partial Consolidation	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Bridging / Fusion	29 Participants	12 Participants	12 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Intact	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Loosening	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Fracture	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Not Applicable	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Unable to Assess	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Subsidence	2 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Subsidence & Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Fusion · Other	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Absent	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Partial Consolidation	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Bridging / Fusion	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Intact	48 Participants	17 Participants	17 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Loosening	0 Participants	1 Participants	1 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Fracture	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Not Applicable	11 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Unable to Assess	1 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Subsidence	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Subsidence & Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Hardware Condition · Other	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Absent	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Partial Consolidation	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Bridging / Fusion	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Intact	28 Participants	12 Participants	12 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Loosening	0 Participants	1 Participants	1 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Fracture	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Not Applicable	3 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Unable to Assess	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Subsidence	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Subsidence & Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Hardware Condition · Other	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Absent	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Partial Consolidation	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Bridging / Fusion	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Intact	58 Participants	16 Participants	15 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Loosening	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Fracture	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Not Applicable	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Unable to Assess	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Subsidence	2 Participants	1 Participants	1 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Migration	0 Participants	0 Participants	1 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Subsidence & Migration	0 Participants	1 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Month Cage Condition · Other	0 Participants	0 Participants	1 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Absent	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Partial Consolidation	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Bridging / Fusion	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Intact	31 Participants	13 Participants	11 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Loosening	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Fracture	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Not Applicable	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Unable to Assess	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Subsidence	0 Participants	0 Participants	1 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Subsidence & Migration	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Month Cage Condition · Other	0 Participants	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: 12 month and 24 month

Population: Patient self-assessment of the procedure at 12M and 24M

At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).

Outcome measures

Outcome measures
Measure	Back n=97 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=56 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Patient Satisfaction Satisfied · Yes	80 Participants	51 Participants	—	—	—	—
Patient Satisfaction Satisfied · No	11 Participants	5 Participants	—	—	—	—
Patient Satisfaction Satisfied · Not Reported	6 Participants	0 Participants	—	—	—	—
Patient Satisfaction Repeat Procedure · Yes	80 Participants	51 Participants	—	—	—	—
Patient Satisfaction Repeat Procedure · No	11 Participants	5 Participants	—	—	—	—
Patient Satisfaction Repeat Procedure · Not Reported	6 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 24 months

At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows: Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment. Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference. Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited. Poor: symptoms or signs unchanged or worse.

Outcome measures

Outcome measures
Measure	Back n=56 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Odom's Criteria Excellent	33 Participants	—	—	—	—	—
Odom's Criteria Good	17 Participants	—	—	—	—	—
Odom's Criteria Fair/Satisfactory	5 Participants	—	—	—	—	—
Odom's Criteria Not Reported	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: During operation.

Population: 3 of 125 subjects did not have surgery time included. There were 12 staged procedures increasing the overall number of procedures to 134

The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.

Outcome measures

Outcome measures
Measure	Back n=134 surgeries Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Surgery Time	142 Minutes Standard Deviation 62.7	—	—	—	—	—

SECONDARY outcome

Timeframe: During operation.

Population: 3 of 125 subjects did not have surgery time included. There were 12 staged procedures increasing the overall number of procedures to 134

The length of time the patient is under anesthesia were captured from the Anesthesia Record.

Outcome measures

Outcome measures
Measure	Back n=134 surgeries Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Anesthesia Time	219.8 Minutes Standard Deviation 84.9	—	—	—	—	—

SECONDARY outcome

Timeframe: During Operation

Population: 11 of 125 subjects did not have blood loss included. There were 12 staged procedures increasing the overall number of procedures to 126.

The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.

Outcome measures

Outcome measures
Measure	Back n=126 surgeries Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Estimated Blood Loss	76.5 Cubic Centimeters Standard Deviation 78.9	—	—	—	—	—

SECONDARY outcome

Timeframe: During operation

Abnormal result(s) of neuromonitoring systems (Train of Four, Electromyography (EMG), Triggered EMG, Somato Sensory Evoked Potential (SSEP) and Motor Evoked Potential (MEP)) utilized during the surgery were captured.

Outcome measures

Outcome measures
Measure	Back n=85 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=121 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=119 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg n=75 Participants Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg n=30 Participants Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Number of Participants With Abnormal Neuromonitoring System Results	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From admission to discharge

The length of hospital stay from the date of hospital admission to the date of discharge was calculated.

Outcome measures

Outcome measures
Measure	Back n=125 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall Overall number of Patients with Adverse Events
Length of Hospital Stay	4.5 Days Standard Deviation 3.3	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-operative to 24 months

Population: All patients who participated in each interval were accounted for including the missing category

The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.

Outcome measures

Outcome measures
Measure	Back n=125 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=122 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=111 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg n=104 Participants Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg n=97 Participants Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall n=56 Participants Overall number of Patients with Adverse Events
Change in Work/School Status Compared to Baseline Unemployed, unrelated to back/leg conditions	16 Participants	25 Participants	22 Participants	22 Participants	16 Participants	8 Participants
Change in Work/School Status Compared to Baseline Not attending work/school by choice	42 Participants	35 Participants	36 Participants	31 Participants	35 Participants	21 Participants
Change in Work/School Status Compared to Baseline Unable to go due to back/leg pain/conditions	30 Participants	41 Participants	24 Participants	18 Participants	16 Participants	10 Participants
Change in Work/School Status Compared to Baseline Attending work/school with some restrictions	25 Participants	15 Participants	14 Participants	15 Participants	8 Participants	5 Participants
Change in Work/School Status Compared to Baseline Attending work/school with no restrictions	12 Participants	5 Participants	14 Participants	17 Participants	20 Participants	12 Participants
Change in Work/School Status Compared to Baseline Missing	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-operative to 24 months

Population: All patients who participated in each interval were accounted for including the missing category

The types and dosages of any narcotics taken by the patient post-surgery were documented.

Outcome measures

Outcome measures
Measure	Back n=125 Participants Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Hip n=122 Participants Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Hip n=111 Participants Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Left Leg n=104 Participants Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Right Leg n=97 Participants Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.	Overall n=56 Participants Overall number of Patients with Adverse Events
Change in Use of Narcotics Post-Surgery Compared to Baseline Back Meds · None	15 Participants	15 Participants	23 Participants	26 Participants	30 Participants	24 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Back Meds · Non-narcotics or NSAIDs	42 Participants	20 Participants	25 Participants	28 Participants	29 Participants	14 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Back Meds · Intermittent short-acting narcotics	21 Participants	38 Participants	34 Participants	27 Participants	16 Participants	7 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Back Meds · Chronic daily short-acting narcotics	30 Participants	24 Participants	20 Participants	17 Participants	15 Participants	9 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Back Meds · Chronic daily long-acting narcotics	16 Participants	19 Participants	7 Participants	6 Participants	3 Participants	1 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Back Meds · IV or injected narcotics	1 Participants	6 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Back Meds · Missing	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Non-Back Meds · None	103 Participants	97 Participants	90 Participants	79 Participants	64 Participants	41 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Non-Back Meds · Non-narcotics or NSAIDs	14 Participants	14 Participants	11 Participants	17 Participants	22 Participants	12 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Non-Back Meds · Intermittent short-acting narcotics	2 Participants	4 Participants	6 Participants	5 Participants	7 Participants	1 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Non-Back Meds · Chronic daily short-acting narcotics	5 Participants	5 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Non-Back Meds · Chronic daily long-acting narcotics	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Non-Back Meds · IV or injected narcotics	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Use of Narcotics Post-Surgery Compared to Baseline Non-Back Meds · Missing	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants

Adverse Events

Participants With Adverse Events

Serious events: 30 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants With Adverse Events n=125 participants at risk Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events. 9 of the 30 SAE participants did not experience a non-SAE events. The other 21 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
Cardiac disorders Cardiac failure	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal pain	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal pain lower	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Functional gastrointestinal disorder	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Intestinal pseudo-obstruction	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Small intestinal obstruction	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Appendicitis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Postoperative wound infection	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Adjacent segment degeneration	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Cerebrospinal fluid leakage	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Fall	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Metabolism and nutrition disorders Fluid overload	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Metabolism and nutrition disorders Hyponatraemia	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Arthritis	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Back pain	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Groin pain	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Muscular weakness	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Neck pain	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 3/125 • Number of events 6 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Cerebrovascular accident	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Cervical cord compression	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Cervical radiculopathy	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Dural tear	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Headache	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Lethargy	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Lumbar radiculopathy	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Lumbar spinal stenosis	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Metabolic encephalopathy	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Syncope	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Product Issues Device dislocation	1.6% 2/125 • Number of events 3 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Confusional state	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Renal and urinary disorders Bladder dysfunction	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Renal and urinary disorders Urinary retention	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Wound drainage	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Carpal tunnel decompression	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Cholecystectomy	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Inguinal hernia repair	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Medical device removal	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Pituitary tumour removal	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Spinal decompression	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Spinal fusion surgery	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Spinal laminectomy	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.

Other adverse events

Other adverse events
Measure	Participants With Adverse Events n=125 participants at risk Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events. 9 of the 30 SAE participants did not experience a non-SAE events. The other 21 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
General disorders Swelling	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Tissue injury	1.6% 2/125 • Number of events 4 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Hepatobiliary disorders Hepatic lesion	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Abscess	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Appendicitis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Bronchitis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Pain	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Pyrexia	3.2% 4/125 • Number of events 4 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Blood and lymphatic system disorders Anaemia postoperative	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Cardiac disorders Bradycardia	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Ear and labyrinth disorders Ear pain	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Eye disorders Eyelid ptosis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Eye disorders Vision blurred	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal discomfort	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal hernia	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal pain	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Anorectal disorder	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Constipation	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Functional gastrointestinal disorder	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Nausea	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Asthenia	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Chest pain	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Discomfort	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Dysplasia	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Fat necrosis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Fatigue	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Nodule	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Upper respiratory tract infection	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Urinary tract infection	4.0% 5/125 • Number of events 5 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Wound infection	2.4% 3/125 • Number of events 3 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Eye contusion	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Fall	8.8% 11/125 • Number of events 13 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Joint injury	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Road traffic accidents	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications skin laceration	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Metabolism and nutrition disorders Osteoporosis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Arthralgia	12.0% 15/125 • Number of events 16 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Arthritis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Back pain	15.2% 19/125 • Number of events 25 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Bursitis	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Costochondritis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Gout	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Meniscus injury	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Muscle injury	1.6% 2/125 • Number of events 4 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Muscle spasms	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Muscle tightness	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Muscular weakness	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.4% 13/125 • Number of events 16 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Neck pain	6.4% 8/125 • Number of events 8 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Pain in extremity	14.4% 18/125 • Number of events 24 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Pseuarthrosis	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Spinal compression fracture	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Spinal fracture	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Cervical radiculopathy	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Dural tear	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Dysaesthesia	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Headache	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Hypoaesthesia	5.6% 7/125 • Number of events 8 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Lumbar radiculopathy	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Lumbar spinal stenosis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Neuralgia	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Neuropathy peripheral	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Paraesthesia	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Peroneal nerve palsy	1.6% 2/125 • Number of events 3 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Piriformis syndrome	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Spinal claudication	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Syncope	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Vertebral foraminal stenosis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Product Issues Device failure	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Anxiety	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Attention deficit / hyperactivity disorder	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Depression	1.6% 2/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Obsessive-compulsive disorder	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Renal and urinary disorders Bladder dysfunction	0.80% 1/125 • Number of events 2 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Renal and urinary disorders Urinary retention	3.2% 4/125 • Number of events 5 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Reproductive system and breast disorders Orchitis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Reproductive system and breast disorders Testicular swelling	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Reproductive system and breast disorders Uterine leiomyoma	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Cellulitis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Erythema	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Blepharoplasty	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Corneal suture	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Incisional drainage	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Spinal fusion	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Deep vein thrombosis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Ecchymosis	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Haematoma	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Haemorrhoidal haemorrhage	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Rectal haemorrhage	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Uterine haemorrhage	0.80% 1/125 • Number of events 1 • Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.

Additional Information

Marissa Conrad, Senior Director of Clinical and Medical Affairs

Stryker Spine

Phone: 201-749-8162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Institution/PI shall not disclose/use any confidential/proprietary information (CI) disclosed to/developed by the Institution during the study. Institution/PI agree to hold the results of the Study in confidence, and shall not disclose them except with prior written consent of K2M. Institution agrees to submit any Articles to K2M for review prior to publication and agrees to edit out any confidential information identified by K2M.
Publication restrictions are in place

Restriction type: OTHER