Trial Outcomes & Findings for Condition of Approval Study (NCT NCT00517751)

NCT ID: NCT00517751

Last Updated: 2018-01-02

Results Overview

Treatment success rate is reported as the percentage of participants who met all of the following criteria: 1. Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (ZCQ) compared to preoperative baseline 2. Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline 3. Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score \< 2.5 4. No additional surgery for lumbar stenosis performed 5. Maintenance of distraction 6. No dislodgement of the implant 7. No device-related complications

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 176 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2018-01-02

Participant Flow

Due to early study termination, the final analysis is consistent with the last annual report submission to the FDA and data reported on FDA's post-approval webpage reporting on 162 of 176 enrolled subjects.

Participant milestones

Measure	X-STOP PEEK In this arm, patients underwent X-STOP PEEK surgery.
Overall Study STARTED	162
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	129

Reasons for withdrawal

Measure	X-STOP PEEK In this arm, patients underwent X-STOP PEEK surgery.
Overall Study Death	3
Overall Study Withdrawal by Subject	37
Overall Study Lost to Follow-up	4
Overall Study patient not over due	6
Overall Study Patient not due for visit	76
Overall Study Missing	3

Baseline Characteristics

Condition of Approval Study

Baseline characteristics by cohort

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Age, Continuous	71.5 years STANDARD_DEVIATION 8.40 • n=93 Participants
Sex: Female, Male Female	75 Participants n=93 Participants
Sex: Female, Male Male	87 Participants n=93 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=93 Participants
Race/Ethnicity, Customized Asian	1 participants n=93 Participants
Race/Ethnicity, Customized Black or African American	4 participants n=93 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 participants n=93 Participants
Race/Ethnicity, Customized Native Hawaiian or other pacific islander	1 participants n=93 Participants
Race/Ethnicity, Customized Caucasian	152 participants n=93 Participants
Race/Ethnicity, Customized Other	0 participants n=93 Participants
Height	67.2 inches STANDARD_DEVIATION 3.93 • n=93 Participants
Weight	188.0 lbs STANDARD_DEVIATION 37.40 • n=93 Participants
Body Mass Index	29.3 kg/m^2 STANDARD_DEVIATION 4.72 • n=93 Participants

PRIMARY outcome

Timeframe: 24 months

Population: At 24 months, 94 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.

Treatment success rate is reported as the percentage of participants who met all of the following criteria:

1. Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (ZCQ) compared to preoperative baseline

2. Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline

3. Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5

4. No additional surgery for lumbar stenosis performed

5. Maintenance of distraction

6. No dislodgement of the implant

7. No device-related complications

Outcome measures

Measure	X-STOP PEEK n=94 Participants In this arm, patients underwent X-STOP PEEK surgery.
Treatment Success Rate at 24 Months	30.9 percentage of participants

SECONDARY outcome

Timeframe: 60 months

Population: At 60 months, 62 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.

Treatment success rate is reported as the percentage of participants who met all of the following criteria:

1. Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline

2. Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline

3. Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5

4. No additional surgery for lumbar stenosis performed

5. Maintenance of distraction

6. No dislodgement of the implant

7. No device-related complications

Outcome measures

Measure	X-STOP PEEK n=62 Participants In this arm, patients underwent X-STOP PEEK surgery.
Treatment Success Rate at 60 Months	24.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. If more than two items were missing, the SS score was considered as missing.

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) SS score baseline (n=161)	3.29 units on a scale Standard Deviation 0.58
Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) SS score at 6 weeks (n=151)	2.10 units on a scale Standard Deviation 0.70
Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) SS score at 12 months (n=103)	2.26 units on a scale Standard Deviation 0.77
Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) SS score at 24 months (n=88)	2.38 units on a scale Standard Deviation 0.85
Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) SS score at 36 months (n=71)	2.25 units on a scale Standard Deviation 0.78
Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) SS score at 48 months (n=59)	2.32 units on a scale Standard Deviation 0.81
Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) SS score at 60 months (n=46)	2.38 units on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months

Success rate in SS domain of ZCQ is reported as percentage of participants who had success in SS domain of the ZCQ. The SS success was defined as clinically significant improvement by at least 0.5 point in SS score compared to preoperative baseline.

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ) SS success at 6 weeks (n=150)	78.0 percentage of participants
Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ) SS success at 12 months (n=102)	71.6 percentage of participants
Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ) SS success at 24 months (n=87)	62.1 percentage of participants
Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ) SS success at 36 months (n=70)	64.3 percentage of participants
Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ) SS success at 48 months (n=59)	61.0 percentage of participants
Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ) SS success at 60 months (n=46)	56.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. If more than one item were missing, the PF score was considered as missing.

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) PF score at baseline (n=162)	2.67 units on a scale Standard Deviation 0.36
Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) PF score at 6 weeks (n=150)	1.79 units on a scale Standard Deviation 0.60
Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) PF score at 12 months (n=103)	1.71 units on a scale Standard Deviation 0.62
Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) PF score at 24 months (n=87)	1.89 units on a scale Standard Deviation 0.69
Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) PF score at 36 months (n=71)	1.93 units on a scale Standard Deviation 0.76
Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) PF score at 48 months (n=59)	1.87 units on a scale Standard Deviation 0.67
Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) PF score at 60 months (n=46)	1.92 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months

Success rate in PF domain of ZCQ is reported as percentage of participants who had success in PF domain of ZCQ. The PF success was defined as clinically significant improvement by at least 0.5 points in PF score compared to preoperative baseline.

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ) PF success at 6 weeks (n=150)	70.7 percentage of participants
Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ) PF success at 12 months (n=103)	71.8 percentage of participants
Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ) PF success at 24 months (n=87)	59.8 percentage of participants
Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ) PF success at 36 months (n=71)	56.3 percentage of participants
Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ) PF success at 48 months (n=59)	61.0 percentage of participants
Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ) PF success at 60 months (n=46)	54.3 percentage of participants

SECONDARY outcome

Timeframe: 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS score at 6 weeks (n=150)	1.75 units on a scale Standard Deviation 0.74
Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS score at 12 months (n=103)	1.78 units on a scale Standard Deviation 0.75
Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS score at 24 months (n=88)	1.90 units on a scale Standard Deviation 0.81
Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS score at 36 months (n=70)	1.84 units on a scale Standard Deviation 0.81
Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS score at 48 months (n=59)	1.89 units on a scale Standard Deviation 0.90
Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS score at 60 months (n=46)	1.91 units on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months

Success rate in PS domain of ZCQ at post treatment is reported as the percentage of participants who had success in PS domain of ZCQ. The PS success was defined as PS score less than 2.5.

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS success at 6 weeks (n=150)	81.3 percentage of participants
Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS success at 12 months (n=103)	80.6 percentage of participants
Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS success at 24 months (n=88)	72.7 percentage of participants
Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS success at 36 months (n=70)	72.9 percentage of participants
Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS success at 48 months (n=59)	67.8 percentage of participants
Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment PS success at 60 months (n=46)	69.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Oswestry Disability Index (ODI) Score ODI score at baseline (n=162)	38.81 units on a scale Standard Deviation 14.11
Oswestry Disability Index (ODI) Score ODI score at 6 weeks (n=151)	22.98 units on a scale Standard Deviation 16.23
Oswestry Disability Index (ODI) Score ODI score at 12 months (n=103)	20.34 units on a scale Standard Deviation 16.27
Oswestry Disability Index (ODI) Score ODI score at 24 months (n=88)	23.99 units on a scale Standard Deviation 17.08
Oswestry Disability Index (ODI) Score ODI score at 36 months (n=71)	23.04 units on a scale Standard Deviation 17.23
Oswestry Disability Index (ODI) Score ODI score at 48 months (n=59)	25.27 units on a scale Standard Deviation 18.22
Oswestry Disability Index (ODI) Score ODI score at 60 months (n=46)	24.88 units on a scale Standard Deviation 18.53

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
General Health Status -- SF-36 PCS SF-36 PCS at baseline (n=162)	27.1 units on a scale Standard Deviation 6.8
General Health Status -- SF-36 PCS SF-36 PCS at 6 week (n=150)	36.3 units on a scale Standard Deviation 10.5
General Health Status -- SF-36 PCS SF-36 PCS at 12 months (n=103)	38.4 units on a scale Standard Deviation 12.2
General Health Status -- SF-36 PCS SF-36 PCS at 24 months (n=88)	35.2 units on a scale Standard Deviation 12.0
General Health Status -- SF-36 PCS SF-36 PCS at 36 months (n=70)	36.4 units on a scale Standard Deviation 12.5
General Health Status -- SF-36 PCS SF-36 PCS at 48 months (n=58)	35.7 units on a scale Standard Deviation 11.8
General Health Status -- SF-36 PCS SF-36 PCS at 60 months (n=46)	35.6 units on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

MCS score is between 0 and 100, with higher scores denoting better quality of life.

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
General Health Status -- SF-36 MCS SF-36 MCS at baseline (n=162)	51.5 units on a scale Standard Deviation 10.8
General Health Status -- SF-36 MCS SF-36 MCS at 6 weeks (n=150)	54.6 units on a scale Standard Deviation 9.5
General Health Status -- SF-36 MCS SF-36 MCS at 12 months (n=103)	53.8 units on a scale Standard Deviation 10.1
General Health Status -- SF-36 MCS SF-36 MCS at 24 months (n=88)	53.4 units on a scale Standard Deviation 11.1
General Health Status -- SF-36 MCS SF-36 MCS at 36 months (n=70)	54.6 units on a scale Standard Deviation 10.8
General Health Status -- SF-36 MCS SF-36 MCS at 48 months (n=58)	54.1 units on a scale Standard Deviation 11.9
General Health Status -- SF-36 MCS SF-36 MCS at 60 months (n=46)	52.8 units on a scale Standard Deviation 12.5

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Back Pain in Numerical Rating Scales (NRS) Back pain at baseline (n=161)	6.4 units on a scale Standard Deviation 2.4
Back Pain in Numerical Rating Scales (NRS) Back pain at 6 weeks (n=150)	3.2 units on a scale Standard Deviation 2.4
Back Pain in Numerical Rating Scales (NRS) Back pain at 12 months (n=103)	3.5 units on a scale Standard Deviation 2.8
Back Pain in Numerical Rating Scales (NRS) Back pain at 24 months (n=88)	4.0 units on a scale Standard Deviation 3.0
Back Pain in Numerical Rating Scales (NRS) Back pain at 36 months (n=70)	3.7 units on a scale Standard Deviation 2.9
Back Pain in Numerical Rating Scales (NRS) Back pain at 48 months (n=59)	3.7 units on a scale Standard Deviation 3.2
Back Pain in Numerical Rating Scales (NRS) Back pain at 60 months (n=46)	3.5 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

Left leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Left Leg Pain in Numerical Rating Scales (NRS) Left leg pain at baseline (n=161)	5.5 units on a scale Standard Deviation 3.0
Left Leg Pain in Numerical Rating Scales (NRS) Left leg pain at 6 weeks (n=150)	1.9 units on a scale Standard Deviation 2.6
Left Leg Pain in Numerical Rating Scales (NRS) Left leg pain at 12 months (n=103)	2.1 units on a scale Standard Deviation 2.8
Left Leg Pain in Numerical Rating Scales (NRS) Left leg pain at 24 months (n=87)	2.7 units on a scale Standard Deviation 2.9
Left Leg Pain in Numerical Rating Scales (NRS) Left leg pain at 36 months (n=70)	2.8 units on a scale Standard Deviation 3.0
Left Leg Pain in Numerical Rating Scales (NRS) Left leg pain at 48 months (n=59)	2.5 units on a scale Standard Deviation 2.9
Left Leg Pain in Numerical Rating Scales (NRS) Left leg pain at 60 months (n=46)	2.7 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

Right leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Right Leg Pain in Numerical Rating Scales (NRS) Right leg pain at baseline (n=161)	5.5 units on a scale Standard Deviation 3.0
Right Leg Pain in Numerical Rating Scales (NRS) Right leg pain at 6 weeks (n=150)	2.0 units on a scale Standard Deviation 2.5
Right Leg Pain in Numerical Rating Scales (NRS) Right leg pain at 12 months (n=103)	2.4 units on a scale Standard Deviation 2.7
Right Leg Pain in Numerical Rating Scales (NRS) Right leg pain at 24 months (n=88)	2.9 units on a scale Standard Deviation 3.1
Right Leg Pain in Numerical Rating Scales (NRS) Right leg pain at 36 months (n=70)	2.3 units on a scale Standard Deviation 2.7
Right Leg Pain in Numerical Rating Scales (NRS) Right leg pain at 48 months (n=59)	2.7 units on a scale Standard Deviation 3.2
Right Leg Pain in Numerical Rating Scales (NRS) Right leg pain at 60 months (n=46)	2.8 units on a scale Standard Deviation 3.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.

The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 24 months is reported.

Outcome measures

Measure	X-STOP PEEK n=53 Participants In this arm, patients underwent X-STOP PEEK surgery.
Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months	9.4 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 months

Population: At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.

The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 60 months is reported.

Outcome measures

Measure	X-STOP PEEK n=16 Participants In this arm, patients underwent X-STOP PEEK surgery.
Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.

The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 24 months is reported.

Outcome measures

Measure	X-STOP PEEK n=53 Participants In this arm, patients underwent X-STOP PEEK surgery.
Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months	9.4 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 months

Population: At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.

The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 60 months is reported.

Outcome measures

Measure	X-STOP PEEK n=16 Participants In this arm, patients underwent X-STOP PEEK surgery.
Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months	25.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Overall study period

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Percent of Subjects Who Reported Implant-Related Adverse Events	11.1 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Overall study period

Outcome measures

Measure	X-STOP PEEK n=162 Participants In this arm, patients underwent X-STOP PEEK surgery.
Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery	19.8 percentage of participants

Adverse Events

X-STOP PEEK

Serious events: 65 serious events

Other events: 118 other events

Deaths: 0 deaths

Serious adverse events

Measure	X-STOP PEEK n=162 participants at risk In this arm, patients will undergo X-STOP PEEK surgery.
Blood and lymphatic system disorders Anaemia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Acute myocardial infarction	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Angina pectoris	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Atrial fibrillation	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Cardiac disorder	0.62% 1/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Cardiogenic shock	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Cardiomyopathy	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Coronary artery disease	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Diastolic dysfunction	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Intracardiac thrombus	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Myocardial infarction	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Myocarditis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Supraventricular tachycardia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Ventricular tachycardia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Ear and labyrinth disorders Ear pain	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Ear and labyrinth disorders Haematotympanum	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Cataract	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Cataract cortical	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Macular hole	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Diverticulum	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Rectal fissure	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Adverse drug reaction	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Death	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Device dislocation	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Device ineffective	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Gait disturbance	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Medical device pain	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Pyrexia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Anal abscess	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Cellulitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Clostridial infection	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Device related infection	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Meningitis bacterial	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Pneumonia	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Post procedural infection	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Postoperative wound infection	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Sepsis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Wound infection staphylococcal	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Animal bite	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Ankle fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Fall	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Hip fracture	1.2% 2/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Incision site complication	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Injury	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Joint dislocation	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Procedural pain	0.62% 1/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Seroma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Spinal compression fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Spinal fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Toxicity to various agents	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Urinary retention postoperative	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Vascular graft complication	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Wound dehiscence	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Anticoagulation drug level above therapeutic	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Blood magnesium decreased	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Blood pressure decreased	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Blood pressure increased	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Cardiac stress test abnormal	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Metabolic acidosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Total fluid volume decreased	0.62% 1/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Back pain	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.2% 2/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Joint ankylosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	2.5% 4/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Muscular weakness	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Osteoarthritis	4.3% 7/162 • Number of events 8 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Pain in extremity	3.1% 5/162 • Number of events 5 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Periarthritis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Scoliosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Spondylolisthesis	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Morton's neuroma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Carpal tunnel syndrome	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Cerebrovascular accident	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Cervical myelopathy	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Cervicobrachial syndrome	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Dizziness	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Hypoaesthesia	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Intracranial hypotension	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Lumbar radiculopathy	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Radiculopathy	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Sensory disturbance	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Spinal claudication	5.6% 9/162 • Number of events 9 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Delusion	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Hallucination	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Renal failure	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Renal failure acute	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Urinary retention	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Reproductive system and breast disorders Cervical polyp	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Aspiration	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Social circumstances Activities of daily living impaired	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Abdominal hernia repair	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Carotid endarterectomy	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures External fixation of fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Hip arthroplasty	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Joint dislocation reduction	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Leg amputation	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Medical device removal	12.3% 20/162 • Number of events 22 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Shoulder arthroplasty	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Aortic aneurysm	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Deep vein thrombosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Hematoma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Hypotension	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Iliac artery thrombosis	0.62% 1/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Vascular insufficiency	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.

Other adverse events

Measure	X-STOP PEEK n=162 participants at risk In this arm, patients will undergo X-STOP PEEK surgery.
Gastrointestinal disorders Duodenal ulcer	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Dyspepsia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Dysphagia	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Faecal incontinence	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Faecaloma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Gastritis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Gastrointestinal infection	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Haemorrhoids	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Levator syndrome	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Nausea	3.7% 6/162 • Number of events 6 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Rectal haemorrhage	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Vomiting	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Adverse drug reaction	2.5% 4/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Asthenia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Axillary pain	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Chest pain	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Complication of device insertion	3.1% 5/162 • Number of events 5 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Device difficult to use	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Device dislocation	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Device material issue	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Fatigue	3.1% 5/162 • Number of events 5 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Gait disturbance	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Malaise	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Non-cardiac chest pain	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Oedema peripheral	1.2% 2/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Pyrexia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
General disorders Xerosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Immune system disorders Autoimmune disorder	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Immune system disorders Hypersensitivity	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Acute sinusitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Blood and lymphatic system disorders Anaemia	2.5% 4/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Blood and lymphatic system disorders Thrombocytopenia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Atrial fibrillation	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Bradycardia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Cardiac failure congestive	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Coronary artery disease	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Diastolic dysfunction	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Cardiac disorders Tachycardia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Ear and labyrinth disorders Ear discomfort	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Ear and labyrinth disorders Vertigo	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Endocrine disorders Hypothyroidism	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Cataract nuclear	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Corneal bleeding	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Glaucoma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Macular degeneration	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Vision blurred	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Eye disorders Vitreous floaters	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Abdominal discomfort	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Abdominal distension	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Abdominal pain	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Abdominal pain lower	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Abdominal pain upper	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Colonic polyp	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Constipation	0.62% 1/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Crohn's disease	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Diarrhoea	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Diverticulitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Gastrointestinal disorders Diverticulum	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Bronchitis	2.5% 4/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Candidiasis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Cystitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Gastrointestinal bacterial infection	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Herpes virus infection	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Herpes zoster	3.1% 5/162 • Number of events 5 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Incision site infection	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Influenza	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Kidney infection	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Laryngitis viral	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Nasopharyngitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Oral herpes	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Otitis externa	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Pharyngitis streptococcal	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Pyelonephritis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Respiratory tract infection bacterial	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Sinusitis	2.5% 4/162 • Number of events 7 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Tooth abscess	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Upper respiratory tract infection	3.1% 5/162 • Number of events 5 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Urinary tract infection	3.7% 6/162 • Number of events 11 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Infections and infestations Wound infection staphylococcal	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Anaemia postoperative	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Back injury	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Clavicle fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Contusion	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Corneal abrasion	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Dural tear	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Excoriation	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Fall	11.1% 18/162 • Number of events 23 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Femur fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Hand fracture	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Incision site complication	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Incision site erythema	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Incision site haemorrhage	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Incision site oedema	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Incision site pain	4.9% 8/162 • Number of events 8 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Incision site pruritus	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Injury	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Joint injury	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Ligament injury	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Ligament rupture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Meniscus lesion	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Muscle strain	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Operative haemorrhage	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Postoperative fever	0.62% 1/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Postoperative ileus	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Postoperative wound complication	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Procedural pain	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Radius fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Rib fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Road traffic accident	2.5% 4/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Scapula fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Seroma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Soft tissue injury	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Spinal fracture	4.9% 8/162 • Number of events 8 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Tendonitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Upper limb fracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Urinary retention postoperative	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Injury, poisoning and procedural complications Wound secretion	3.1% 5/162 • Number of events 6 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Blood glucose increased	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Blood potassium increased	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Blood pressure decreased	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Blood pressure increased	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Blood triglycerides increased	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Body temperature increased	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Glysolated haemoglobin increased	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Pulse absent	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Spinal x-ray abnormal	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Investigations Weight decreased	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Dehydration	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Diabetes mellitus	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Fluid retention	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Glucose tolerance impaired	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Gout	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Hypercholesterolaemia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Hyperglycaemia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Hyperlipidaemia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Hypokalaemia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 17/162 • Number of events 21 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Arthritis	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Back pain	21.6% 35/162 • Number of events 49 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Bursitis	3.7% 6/162 • Number of events 6 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Coccydynia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Flank pain	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Groin pain	2.5% 4/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Joint swelling	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Joint contracture	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Joint crepitation	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Lower extremity mass	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	3.1% 5/162 • Number of events 5 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Muscle spasms	6.8% 11/162 • Number of events 13 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Muscle tightness	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Muscular weakness	2.5% 4/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.2% 10/162 • Number of events 13 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Myalgia	3.1% 5/162 • Number of events 5 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Neck pain	6.8% 11/162 • Number of events 11 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Osteoarthritis	7.4% 12/162 • Number of events 12 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Osteopenia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Osteoporosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 18/162 • Number of events 19 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Periarthritis	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Plantar fasciitis	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.9% 3/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Scoliosis	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.9% 3/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Morton's neuroma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	1.9% 3/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Amnesia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Carpal tunnel syndrome	1.2% 2/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Cerebral atrophy	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Cerebral small vessel ischaemic disease	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Coordination abnormal	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Diabetic neuropathy	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Dizziness	1.2% 2/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Headache	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Hypoaesthesia	3.7% 6/162 • Number of events 9 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Lethargy	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Lumbar radiculopathy	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Multiple sclerosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Neuralgia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Neuropathy peripheral	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Paraesthesia	1.9% 3/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Poor quality sleep	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Presyncope	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Radicular pain	3.1% 5/162 • Number of events 5 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Senile dementia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Spinal claudication	4.9% 8/162 • Number of events 12 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Nervous system disorders Tarsal tunnel syndrome	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Agitation	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Anxiety	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Depression	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Flashback	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Grief reaction	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Insomnia	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Psychiatric disorders Sleep disorder	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Dysuria	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Haematuria	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Micturition urgency	0.62% 1/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Nocturia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Pollakiuria	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Renal failure	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Strangury	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Renal and urinary disorders Urinary retention	1.9% 3/162 • Number of events 3 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Reproductive system and breast disorders Breast cyst	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Reproductive system and breast disorders Breast mass	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Reproductive system and breast disorders Erectile dysfunction	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Reproductive system and breast disorders Gynaecomastia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Reproductive system and breast disorders Vulvovaginal dryness	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Asthma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Dysponea exertional	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Hiccups	0.62% 1/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Respiratory, thoracic and mediastinal disorders Vocal cord disorder	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Actinic keratosis	2.5% 4/162 • Number of events 4 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Dermatitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Dermatitis contact	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Erythema	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Nail disorder	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Pruritus	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Rash	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Skin and subcutaneous tissue disorders Seborrheic dermatitis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Corneal transplant	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Endodontic procedure	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Hip arthroplasty	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Incisional drainage	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Knee arthroplasty	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Surgical and medical procedures Medical device removal	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Arterial thrombosis	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Arteriovenous fistula	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Haematoma	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Hypotension	0.62% 1/162 • Number of events 1 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.
Vascular disorders Peripheral coldness	1.2% 2/162 • Number of events 2 • Overall study period (up to 60 months) Due to early study termination, not all subjects were followed through 60 months.

Additional Information

Clinical Department

Medtronic Spinal and biologics

Phone: 1800-876-3133

Email: msbkclinicalresearch@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60