Trial Outcomes & Findings for Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System (NCT NCT02064855)

NCT ID: NCT02064855

Last Updated: 2021-03-01

Results Overview

All adverse events will be documented including device related, procedure related and additional serious adverse events.

• Recruitment status: TERMINATED
• Target enrollment: 108 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2021-03-01

Participant Flow

Participant milestones

Measure	EVEREST/VESUVIUS Demineralized Fibers This group involves patients treated with the VESUVIUS Demineralized Fibers and EVEREST system that had: 1. Diagnosis of spinal stenosis, spondylolisthesis (grade 1 or 2), and/or degenerative disc disease (DDD). 2. Qualified for inclusion by patient history and radiographic studies. 3. One or two contiguous levels requiring surgical intervention between L1-S1 Skeletally mature and greater than or equal to 18 years old at time of enrollment
Overall Study STARTED	108
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The study Case Report Forms did not include Race/Ethnicity

Baseline characteristics by cohort

Measure	Demographics and Baseline Characteristics n=108 Participants Demographics and Baseline Characteristics (Patient Population)
Age, Categorical <=18 years	0 Participants n=108 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=108 Participants
Age, Categorical >=65 years	45 Participants n=108 Participants
Age, Continuous	59.45 years STANDARD_DEVIATION 13.31 • n=108 Participants
Sex: Female, Male Female	56 Participants n=108 Participants
Sex: Female, Male Male	52 Participants n=108 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	108 participants n=108 Participants
Height	66.57 inches STANDARD_DEVIATION 4.09 • n=108 Participants
Weight	187.19 pounds STANDARD_DEVIATION 37.67 • n=108 Participants
Body Mass Index (BMI)	29.61 lbs/(in^2)*703 STANDARD_DEVIATION 4.86 • n=108 Participants
Tobacco Use Never	47 Participants n=108 Participants
Tobacco Use Quit	45 Participants n=108 Participants
Tobacco Use Currently Use	16 Participants n=108 Participants
Tobacco Use Missing	0 Participants n=108 Participants

PRIMARY outcome

Timeframe: 24 months

All adverse events will be documented including device related, procedure related and additional serious adverse events.

Outcome measures

Measure	Up to Post Operative n=108 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=108 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months n=108 Participants AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months n=108 Participants AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months n=108 Participants AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall n=108 Participants Overall AEs and SAEs
Number of Participants With Adverse Events Any AE	51 participants	15 participants	19 participants	23 participants	24 participants	76 participants
Number of Participants With Adverse Events Any AE: Procedure Related	28 participants	0 participants	1 participants	1 participants	4 participants	50 participants
Number of Participants With Adverse Events Any AE: Device Related	2 participants	0 participants	0 participants	0 participants	1 participants	3 participants
Number of Participants With Adverse Events Any AE: Mild	21 participants	5 participants	4 participants	5 participants	8 participants	36 participants
Number of Participants With Adverse Events Any AE: Moderate	34 participants	10 participants	14 participants	17 participants	17 participants	60 participants
Number of Participants With Adverse Events Any AE: Severe	10 participants	0 participants	4 participants	4 participants	2 participants	19 participants
Number of Participants With Adverse Events Any SAE	16 participants	0 participants	4 participants	5 participants	3 participants	25 participants
Number of Participants With Adverse Events Any SAE: Procedure Related	10 participants	0 participants	0 participants	0 participants	1 participants	11 participants
Number of Participants With Adverse Events Any SAE: Device Related	2 participants	0 participants	0 participants	0 participants	0 participants	2 participants
Number of Participants With Adverse Events Any SAE: Mild	3 participants	0 participants	0 participants	0 participants	0 participants	3 participants
Number of Participants With Adverse Events Any SAE: Moderate	6 participants	0 participants	2 participants	2 participants	1 participants	11 participants
Number of Participants With Adverse Events Any SAE: Severe	7 participants	0 participants	1 participants	3 participants	2 participants	12 participants

PRIMARY outcome

Timeframe: 12 months

Population: Image Assessed at Visit

Fusion is categorized as Partial consolidation and Bridging/Fusion. Partial consolidation is defined as consolidation of bone graft material with no complete bridging seen. Bridging/Fusion is defined as clear evidence of solid bridging bone between posterolateral gutters, facet joints and/or transverse processes.

Outcome measures

Measure	Up to Post Operative n=80 Number of Image Assessed AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Fusion Status on CT at 12 Months Fused	63 Number of Image Assessed	—	—	—	—	—
Fusion Status on CT at 12 Months Not Fused	17 Number of Image Assessed	—	—	—	—	—

SECONDARY outcome

Timeframe: 12m

Population: Each Arm/group has different overall number of participants assessed.

X-rays at pre-operative and post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include:

• Posterior/Transverse process fusion, Right side (by level)
• Posterior/Transverse process fusion, Left side (by level)
• Anterior fusion, if TLIF procedure done, by level
• Overall fusion by level
• Device Condition
• Device Subsidence
• Device Migration

Outcome measures

Measure	Up to Post Operative n=84 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=84 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months n=104 Participants AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Radiographic Assessments 3:2 (Vesuvius Fibers: BMA) · Bridging/Fusion	13 Participants	—	—	—	—	—
Radiographic Assessments 3:2 (Vesuvius Fibers: BMA) · Partial Consolidation	13 Participants	—	—	—	—	—
Radiographic Assessments 3:2 (Vesuvius Fibers: BMA) · Absent	4 Participants	—	—	—	—	—
Radiographic Assessments 3:2 (Vesuvius Fibers: BMA) · Unknown	1 Participants	—	—	—	—	—
Radiographic Assessments 1:1 (Vesuvius Fibers: BMA) · Bridging/Fusion	7 Participants	—	—	—	—	—
Radiographic Assessments 1:1 (Vesuvius Fibers: BMA) · Partial Consolidation	9 Participants	—	—	—	—	—
Radiographic Assessments 1:1 (Vesuvius Fibers: BMA) · Absent	9 Participants	—	—	—	—	—
Radiographic Assessments 1:1 (Vesuvius Fibers: BMA) · Unknown	1 Participants	—	—	—	—	—
Radiographic Assessments Other · Bridging/Fusion	11 Participants	—	—	—	—	—
Radiographic Assessments Other · Partial Consolidation	9 Participants	—	—	—	—	—
Radiographic Assessments Other · Absent	5 Participants	—	—	—	—	—
Radiographic Assessments Other · Unknown	2 Participants	—	—	—	—	—
Radiographic Assessments 1 Level · Bridging/Fusion	—	27 Participants	—	—	—	—
Radiographic Assessments 1 Level · Partial Consolidation	—	21 Participants	—	—	—	—
Radiographic Assessments 1 Level · Absent	—	13 Participants	—	—	—	—
Radiographic Assessments 1 Level · Unknown	—	3 Participants	—	—	—	—
Radiographic Assessments 2 Levels · Bridging/Fusion	—	3 Participants	—	—	—	—
Radiographic Assessments 2 Levels · Partial Consolidation	—	12 Participants	—	—	—	—
Radiographic Assessments 2 Levels · Absent	—	4 Participants	—	—	—	—
Radiographic Assessments 2 Levels · Unknown	—	1 Participants	—	—	—	—
Radiographic Assessments L3-L4 · Bridging/Fusion	—	—	5 Participants	—	—	—
Radiographic Assessments L3-L4 · Partial Consolidation	—	—	7 Participants	—	—	—
Radiographic Assessments L3-L4 · Absent	—	—	2 Participants	—	—	—
Radiographic Assessments L3-L4 · Unknown	—	—	0 Participants	—	—	—
Radiographic Assessments L4-L5 · Bridging/Fusion	—	—	22 Participants	—	—	—
Radiographic Assessments L4-L5 · Partial Consolidation	—	—	25 Participants	—	—	—
Radiographic Assessments L4-L5 · Absent	—	—	12 Participants	—	—	—
Radiographic Assessments L4-L5 · Unknown	—	—	4 Participants	—	—	—
Radiographic Assessments L5-S1 · Bridging/Fusion	—	—	7 Participants	—	—	—
Radiographic Assessments L5-S1 · Partial Consolidation	—	—	11 Participants	—	—	—
Radiographic Assessments L5-S1 · Absent	—	—	8 Participants	—	—	—
Radiographic Assessments L5-S1 · Unknown	—	—	1 Participants	—	—	—

SECONDARY outcome

Timeframe: 12 Months and 24 Months

Population: The participants data analyzed differ from the overall number of participants for the Arms. Cages were optional per protocol as such the decrease in the number of participants.

X-rays at post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include:

Device Condition Device Subsidence Device Migration

Outcome measures

Measure	Up to Post Operative n=79 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=29 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months n=29 Participants AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Radiographic Assessments 12 Mo Hardware Condition · Intact	51 Participants	16 Participants	19 Participants	—	—	—
Radiographic Assessments 12 Mo Hardware Condition · Loosening	12 Participants	4 Participants	1 Participants	—	—	—
Radiographic Assessments 12 Mo Hardware Condition · Fracture	1 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Mo Hardware Condition · Absent	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Mo Hardware Condition · Partial Consolidation	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Mo Hardware Condition · Bridging/Fusion	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Mo Hardware Condition · Unable to assess	0 Participants	1 Participants	1 Participants	—	—	—
Radiographic Assessments 24 Mo Hardware Condition · Intact	32 Participants	10 Participants	13 Participants	—	—	—
Radiographic Assessments 24 Mo Hardware Condition · Loosening	4 Participants	4 Participants	1 Participants	—	—	—
Radiographic Assessments 24 Mo Hardware Condition · Fracture	1 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Mo Hardware Condition · Absent	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Mo Hardware Condition · Partial Consolidation	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Mo Hardware Condition · Bridging/Fusion	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Mo Hardware Condition · Unable to assess	2 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Mo Cage Condition · Intact	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Mo Cage Condition · Loosening	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Mo Cage Condition · Fracture	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 12 Mo Cage Condition · Absent	8 Participants	2 Participants	4 Participants	—	—	—
Radiographic Assessments 12 Mo Cage Condition · Partial Consolidation	3 Participants	5 Participants	4 Participants	—	—	—
Radiographic Assessments 12 Mo Cage Condition · Bridging/Fusion	10 Participants	2 Participants	3 Participants	—	—	—
Radiographic Assessments 12 Mo Cage Condition · Unable to assess	1 Participants	1 Participants	1 Participants	—	—	—
Radiographic Assessments 24 Mo Cage Condition · Intact	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Mo Cage Condition · Loosening	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Mo Cage Condition · Fracture	0 Participants	0 Participants	0 Participants	—	—	—
Radiographic Assessments 24 Mo Cage Condition · Absent	3 Participants	1 Participants	1 Participants	—	—	—
Radiographic Assessments 24 Mo Cage Condition · Partial Consolidation	1 Participants	2 Participants	2 Participants	—	—	—
Radiographic Assessments 24 Mo Cage Condition · Bridging/Fusion	12 Participants	2 Participants	3 Participants	—	—	—
Radiographic Assessments 24 Mo Cage Condition · Unable to assess	1 Participants	1 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-Op), 24 months

Population: While 53 participants completed the study, 1 patient did not complete the survey at 24 Month. 2 patient did not complete the survey at 12 Month. 5 patient did not complete the survey at 6 Month. 4 patient did not complete the survey at 3 Month. 2 patient did not complete the survey at Initial Post-Op. 1 patient did not complete the survey at Pre-Op.

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 0 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

Measure	Up to Post Operative n=107 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=101 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months n=98 Participants AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months n=90 Participants AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months n=83 Participants AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall n=52 Participants Overall AEs and SAEs
Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) Baseline	45.1 score on a scale Standard Deviation 17.2	36.4 score on a scale Standard Deviation 19.5	24.3 score on a scale Standard Deviation 18.3	20.5 score on a scale Standard Deviation 18.2	18.0 score on a scale Standard Deviation 18.3	16.6 score on a scale Standard Deviation 18.4
Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) Change from Baseline	NA score on a scale Standard Deviation NA This field is not applicable as it is the baseline and there would not be any change from the baseline	-8.0 score on a scale Standard Deviation 20.9	-20.3 score on a scale Standard Deviation 19.9	-24.4 score on a scale Standard Deviation 19.7	-25.8 score on a scale Standard Deviation 18.9	-26.3 score on a scale Standard Deviation 21.0

SECONDARY outcome

Timeframe: Baseline (up to 8 weeks post-operatively) to 24 months

Population: While 53 participants completed the study, 1-2 patients did not complete the survey

VAS scale ranged from 0 to 100mm with the 100mm accounting for the highest level of pain

Outcome measures

Measure	Up to Post Operative n=52 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=51 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months n=52 Participants AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months n=51 Participants AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months n=51 Participants AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months	-44.3 score on a scale Standard Deviation 30.51	-38.6 score on a scale Standard Deviation 35.82	-27.9 score on a scale Standard Deviation 39.02	-37.9 score on a scale Standard Deviation 38.90	-36.1 score on a scale Standard Deviation 42.90	—

SECONDARY outcome

Timeframe: Baseline (up to 8 weeks post-operatively) to 24 months

Population: While 53 participants completed the study, 1 patient did not complete the survey.

SF-12v2 ranged between 0 and 100 points. The higher the points the better the self-assessed quality of life.

Outcome measures

Measure	Up to Post Operative n=52 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=52 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months	4.603 score on a scale Standard Deviation 10.257	11.734 score on a scale Standard Deviation 10.042	—	—	—	—

SECONDARY outcome

Timeframe: 12 months, 24 months

Population: All participants for both intervals filled out the surveys

Patient Satisfaction at 12 Mo and 24 Mo

Outcome measures

Measure	Up to Post Operative n=85 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=53 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Patient Satisfaction Satisfied · Yes	72 Participants	43 Participants	—	—	—	—
Patient Satisfaction Satisfied · No	5 Participants	6 Participants	—	—	—	—
Patient Satisfaction Satisfied · Not Reported	8 Participants	4 Participants	—	—	—	—
Patient Satisfaction Repeat Procedure · Yes	71 Participants	45 Participants	—	—	—	—
Patient Satisfaction Repeat Procedure · No	5 Participants	4 Participants	—	—	—	—
Patient Satisfaction Repeat Procedure · Not Reported	9 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At time of surgery

Population: 5 Subjects did not have a surgical time recorded

The length of the surgical procedure from the initial incision to final closure.

Outcome measures

Measure	Up to Post Operative n=103 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Length of Surgery Time	3.12 Hours Standard Deviation 1.29	—	—	—	—	—

SECONDARY outcome

Timeframe: At time of surgery

Population: 6 Subjects did not have anesthesia time recorded

The length of time the patient is under anesthesia.

Outcome measures

Measure	Up to Post Operative n=102 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Length of Anesthesia Time	4.23 Hours Standard Deviation 1.40	—	—	—	—	—

SECONDARY outcome

Timeframe: At time of surgery

Population: 1 Subject did not have the amount of blood loss recorded

The amount of blood loss over the entire length of the surgery

Outcome measures

Measure	Up to Post Operative n=107 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Estimated Blood Loss	250.50 Cubic Centimeters Standard Deviation 238.79	—	—	—	—	—

SECONDARY outcome

Timeframe: Admission to discharge

Population: All patients are accounted for

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

Outcome measures

Measure	Up to Post Operative n=108 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall Overall AEs and SAEs
Length of Hospital Stay	4.15 Days Standard Deviation 1.83	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-Op to 24 months

Population: Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.

The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the percentage increase of participants who were able to return to work without any restrictions.

Outcome measures

Measure	Up to Post Operative n=108 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=103 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months n=100 Participants AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months n=95 Participants AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months n=85 Participants AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall n=53 Participants Overall AEs and SAEs
Time to Return to Work/School Unable to go due to back/leg pain/conditions	14 Participants	43 Participants	15 Participants	3 Participants	4 Participants	5 Participants
Time to Return to Work/School Attending work/school with some restrictions	20 Participants	15 Participants	24 Participants	18 Participants	10 Participants	1 Participants
Time to Return to Work/School Attending work/school with no restrictions	31 Participants	2 Participants	19 Participants	28 Participants	36 Participants	28 Participants
Time to Return to Work/School Missing	0 Participants	0 Participants	0 Participants	4 Participants	3 Participants	1 Participants
Time to Return to Work/School Unemployment, unrelated to back/leg conditions	21 Participants	19 Participants	20 Participants	23 Participants	15 Participants	2 Participants
Time to Return to Work/School Not attending work/school by choice	22 Participants	24 Participants	22 Participants	19 Participants	17 Participants	16 Participants

SECONDARY outcome

Timeframe: Pre-Op to 24 months

Population: Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.

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

Outcome measures

Measure	Up to Post Operative n=108 Participants AEs and SAEs that occurred at the beginning of the study up to Post Operative	Post-Operative to 3 Months n=103 Participants AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months	3 to 6 Months n=100 Participants AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months	6 to 12 Months n=95 Participants AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months	12 to 24+ Months n=85 Participants AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months	Overall n=53 Participants Overall AEs and SAEs
Use of Narcotics Post-surgery Back Meds · Chronic daily short-acting narcotics	26 Participants	36 Participants	16 Participants	12 Participants	7 Participants	2 Participants
Use of Narcotics Post-surgery Back Meds · Chronic daily long-acting narcotics	5 Participants	6 Participants	5 Participants	1 Participants	3 Participants	1 Participants
Use of Narcotics Post-surgery Back Meds · IV or injected narcotics	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Back Meds · Epidural/Facet injections	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Use of Narcotics Post-surgery Back Meds · Missing	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants
Use of Narcotics Post-surgery Non-Back Meds · None	79 Participants	80 Participants	81 Participants	64 Participants	60 Participants	36 Participants
Use of Narcotics Post-surgery Non-Back Meds · Non-narcotics or NSAIDs	20 Participants	15 Participants	14 Participants	25 Participants	16 Participants	14 Participants
Use of Narcotics Post-surgery Non-Back Meds · Intermittent short-acting narcotics	6 Participants	7 Participants	2 Participants	4 Participants	5 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · Chronic daily short-acting narcotics	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	1 Participants
Use of Narcotics Post-surgery Non-Back Meds · Chronic daily long-acting narcotics	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · IV or injected narcotics	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · Epidural/Facet injections	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · Missing	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants
Use of Narcotics Post-surgery Back Meds · None	11 Participants	9 Participants	24 Participants	34 Participants	43 Participants	27 Participants
Use of Narcotics Post-surgery Back Meds · Non-narcotics or NSAIDs	42 Participants	15 Participants	32 Participants	32 Participants	23 Participants	19 Participants
Use of Narcotics Post-surgery Back Meds · Intermittent short-acting narcotics	20 Participants	37 Participants	23 Participants	14 Participants	7 Participants	2 Participants

Adverse Events

Participants With Adverse Events

Serious events: 25 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants With Adverse Events n=108 participants at risk Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events. 3 of the 25 SAE participants did not experience a non-SAE events. The other 22 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
Cardiac disorders Coronary artery disease	0.93% 1/108 • Number of events 1 • From 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 Gastrointestinal anastomotic stenosis	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Incision site pain	0.93% 1/108 • Number of events 1 • From 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 Wound dehiscence	1.9% 2/108 • Number of events 2 • From 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	1.9% 2/108 • Number of events 2 • From 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 Pseudarthrosis	0.93% 1/108 • Number of events 1 • From 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm malignant	0.93% 1/108 • Number of events 1 • From 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 Carpal tunnel syndrome	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	1.9% 2/108 • Number of events 2 • From 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 Ileus	0.93% 1/108 • Number of events 1 • From 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 Gallbladder disorder	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Post procedural	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Joint hyperextension	0.93% 1/108 • Number of events 1 • From 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 Kyphosis	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Drug abuse	0.93% 1/108 • Number of events 1 • From 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 Mental status changes	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Cardiac pacemaker insertion	0.93% 1/108 • Number of events 1 • From 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 Haemorrhage	0.93% 1/108 • Number of events 1 • From 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 Iliac vein perforation	0.93% 1/108 • Number of events 1 • From 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 Myocardial infarction	0.93% 1/108 • Number of events 1 • From 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

Measure	Participants With Adverse Events n=108 participants at risk Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events. 3 of the 25 SAE participants did not experience a non-SAE events. The other 22 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
Cardiac disorders Atrial fibrillation	0.93% 1/108 • Number of events 1 • From 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 Eye contusion	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Anal fissure	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Vomitting	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	2.8% 3/108 • Number of events 3 • From 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	0.93% 1/108 • Number of events 1 • From 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 Gait disturbance	0.93% 1/108 • Number of events 1 • From 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 Impaired healing	3.7% 4/108 • Number of events 5 • From 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 Incision site impaired healing	0.93% 1/108 • Number of events 2 • From 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	0.93% 1/108 • Number of events 2 • From 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 Peripheral swelling	3.7% 4/108 • Number of events 5 • From 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 Post procedural fever	0.93% 1/108 • Number of events 1 • From 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 Abdominal infection	0.93% 1/108 • Number of events 1 • From 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 Pharyngitis	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	5.6% 6/108 • Number of events 9 • From 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 Fractured sacrum	0.93% 1/108 • Number of events 1 • From 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 Implant site erosion	0.93% 1/108 • Number of events 1 • From 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 incision site haemorrhage	0.93% 1/108 • Number of events 1 • From 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 Ligament sprain	0.93% 1/108 • Number of events 1 • From 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 Musculoskeletal procedural complication	2.8% 3/108 • Number of events 3 • From 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 Procedural pain	0.93% 1/108 • Number of events 1 • From 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 accident	0.93% 1/108 • Number of events 1 • From 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 Rotator cuff syndrome	0.93% 1/108 • Number of events 1 • From 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 Spinal compression fracture	0.93% 1/108 • Number of events 1 • From 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 Spinal fracture	0.93% 1/108 • Number of events 1 • From 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 Urinary retention postoperative	1.9% 2/108 • Number of events 2 • From 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 Wound dehiscence	0.93% 1/108 • Number of events 1 • From 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.
Investigations Body temperature increased	0.93% 1/108 • Number of events 2 • From 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.
Investigations Culture negative	0.93% 1/108 • Number of events 1 • From 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.
Investigations Electrocardiogram	0.93% 1/108 • Number of events 1 • From 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.
Investigations Electrocardiogram ambulatory	0.93% 1/108 • Number of events 1 • From 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.
Investigations Lasegue's test positive	1.9% 2/108 • Number of events 3 • From 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 Diabetic neuropathy	0.93% 1/108 • Number of events 1 • From 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	13.0% 14/108 • Number of events 17 • From 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	25.0% 27/108 • Number of events 33 • From 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 Coccydynia	3.7% 4/108 • Number of events 4 • From 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	0.93% 1/108 • Number of events 1 • From 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	1.9% 2/108 • Number of events 2 • From 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 Incomplete spinal fusion	1.9% 2/108 • Number of events 3 • From 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	2.8% 3/108 • Number of events 3 • From 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 Joint swelling	0.93% 1/108 • Number of events 1 • From 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 Limb asymmetry	0.93% 1/108 • Number of events 1 • From 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 Lower limb fracture	0.93% 1/108 • Number of events 1 • From 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	3.7% 4/108 • Number of events 4 • From 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 strain	0.93% 1/108 • Number of events 2 • From 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	0.93% 1/108 • Number of events 1 • From 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	2.8% 3/108 • Number of events 5 • From 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 chest pain	0.93% 1/108 • Number of events 1 • From 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	8.3% 9/108 • Number of events 10 • From 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 Myofascial pain syndrome	0.93% 1/108 • Number of events 1 • From 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	5.6% 6/108 • Number of events 6 • From 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 Osteoporosis	0.93% 1/108 • Number of events 1 • From 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	17.6% 19/108 • Number of events 24 • From 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 Restless legs syndrome	0.93% 1/108 • Number of events 1 • From 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 Sacroilitis	0.93% 1/108 • Number of events 1 • From 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 Sciatica	0.93% 1/108 • Number of events 1 • From 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 disorder	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Wrist fracture	0.93% 1/108 • Number of events 1 • From 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 twitching	0.93% 1/108 • Number of events 2 • From 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 Cerebrospinal fluid leakage	0.93% 1/108 • Number of events 1 • From 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	3.7% 4/108 • Number of events 4 • From 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	0.93% 1/108 • Number of events 1 • From 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	1.9% 2/108 • Number of events 2 • From 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% 6/108 • Number of events 6 • From 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	1.9% 2/108 • Number of events 2 • From 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	2.8% 3/108 • Number of events 3 • From 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 Nerve compression	0.93% 1/108 • Number of events 2 • From 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	0.93% 1/108 • Number of events 1 • From 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	1.9% 2/108 • Number of events 3 • From 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 Incision site impaired healing	0.93% 1/108 • Number of events 1 • From 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 Confusion postoperative	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Calculus urinal	0.93% 1/108 • Number of events 1 • From 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 Haematuria	0.93% 1/108 • Number of events 1 • From 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 Nephrolithiasis	0.93% 1/108 • Number of events 1 • From 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 pain	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 1 • From 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 Basal cell carcinoma	0.93% 1/108 • Number of events 1 • From 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 Rash	1.9% 2/108 • Number of events 4 • From 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 Skin laceration	0.93% 1/108 • Number of events 1 • From 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	0.93% 1/108 • Number of events 2 • From 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 Contusion	0.93% 1/108 • Number of events 1 • From 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	1.9% 2/108 • Number of events 2 • From 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 Hypertension	0.93% 1/108 • Number of events 1 • From 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 Peripheral vascular disorder	0.93% 1/108 • Number of events 1 • From 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 Perthes disease	0.93% 1/108 • Number of events 1 • From 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: marissa.conrad@stryker.com

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