Lumbar Spinal Stenosis
Conditions
Keywords
Lumbar Spinal Stenosis, X STOP
Brief summary
The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery.
Detailed description
Evaluate the long term safety and effectiveness of the X-Stop interspinous process decompression system In the patients who received the X-Stop under the IDE. These patients consist of two cohorts to be evaluated: patients who had moderately impaired physical function prior to X-Stop implantation (as determined by a baseline score \>2.0 in the physical function (PF) domain of the Zurich claudication questionnaire), and patients who had mildly impaired physical function prior to X-Stop surgery(as determined by a baseline score \<=2.0 in the PF domain of the Zurich claudication questionnaire (ZCQ), through the fifth postoperative year. Clinical examination will be performed at each office visit to confirm the absence of neurological complications. X-ray films (AP/lateral views) taken during the fifth postoperative year will, be analyzed to confirm A) maintenance of distraction and B) the absence of radiological evidence of device-related complications. Secondary endpoints will include mean scores from the SF-36, and incidence rates of adverse events, device failures, and secondary surgeries.
Interventions
DEVICEX STOP® Interspinous Process Decompression System
The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It is made from Ti-6AI-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a spacer assembly and a wing assembly.
Sponsors
Medtronic Spine LLC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria: 1. Completed participation in the Pivotal Trial, CAP, or COS and has the X STOP implant(s) intact at the time of LTOS enrollment; OR is an active CAP/COS participant, has the X STOP implant(s) intact, and has not completed a 24-month follow-up visit in his/her CAP/COS study. 2. Is willing and able to provide Informed Consent 3. Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.
Exclusion criteria
A patient will not be admitted into the LTOS program if he/she meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Rates (At ≥ 5 Years) | 3+ years following first 2 years post-X-STOP implant through IDE study | Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of \<2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study | ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). 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 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score. |
| Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | 3+ years following first 2 years post-X-STOP implant through IDE study | ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores \<2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction. |
| Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study | Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary \[PCS\] and mental component summary \[MCS\]). Scores for each subdomain and component summary range from 0 worst to 100 best. The change from baseline to the 5 year postoperative visit for each of these domains is presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | 3+ years following first 2 years post-X-STOP implant through IDE study | The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other. |
| Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | 3+ years following first 2 years post-X-STOP implant through IDE study | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Target Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ). | 55 |
| Safety Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ. | 14 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | personal reasons/family concerns | 1 | 0 |
Baseline characteristics
| Characteristic | Safety | Total | Target |
|---|---|---|---|
| Age, Continuous | 76.0 years STANDARD_DEVIATION 8.9 | 72.9 years STANDARD_DEVIATION 10.1 | 72.1 years STANDARD_DEVIATION 10.2 |
| Race/Ethnicity, Customized Asian | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Native Hawaiian / Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Unknown | 2 participants | 7 participants | 5 participants |
| Race/Ethnicity, Customized White | 12 participants | 58 participants | 46 participants |
| Sex: Female, Male Female | 8 Participants | 31 Participants | 23 Participants |
| Sex: Female, Male Male | 6 Participants | 38 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 48 / 55 | 13 / 14 | 61 / 69 |
| serious Total, serious adverse events | 11 / 55 | 4 / 14 | 15 / 69 |
Outcome results
Primary
Treatment Success Rates (At ≥ 5 Years)
Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of \<2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.
Time frame: 3+ years following first 2 years post-X-STOP implant through IDE study
Population: Patients who received the X-STOP and 1) completed the IDE trial or CAP/COS under IDE #G990128 or 2) were participating in the CAP/COS program, were eligible for the LTOS study. 55 included in analysis met moderately impaired baseline physical function. 14 had mildly impaired physical function at baseline and were analyzed as separate safety cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Target | Treatment Success Rates (At ≥ 5 Years) | Treatment success rate (n=49, 13, 62) | 40.8 percentage of participants |
| Target | Treatment Success Rates (At ≥ 5 Years) | SS improved >=0.5 point (n=52, 13, 65) | 53.8 percentage of participants |
| Target | Treatment Success Rates (At ≥ 5 Years) | PF improved >=0.5 point (n=52, 14, 66) | 73.1 percentage of participants |
| Target | Treatment Success Rates (At ≥ 5 Years) | PS Score <2.5 (n=53, 14, 67) | 81.1 percentage of participants |
| Target | Treatment Success Rates (At ≥ 5 Years) | No additional surgery at index level(n=53, 14, 67) | 94.3 percentage of participants |
| Target | Treatment Success Rates (At ≥ 5 Years) | Maintenance of distraction (n=42, 11, 53) | 95.2 percentage of participants |
| Target | Treatment Success Rates (At ≥ 5 Years) | No dislodgement of implant (n=43, 11, 54) | 100.0 percentage of participants |
| Target | Treatment Success Rates (At ≥ 5 Years) | No device-related complication (n=53, 14, 67) | 94.3 percentage of participants |
| Safety | Treatment Success Rates (At ≥ 5 Years) | PF improved >=0.5 point (n=52, 14, 66) | 50.0 percentage of participants |
| Safety | Treatment Success Rates (At ≥ 5 Years) | No dislodgement of implant (n=43, 11, 54) | 81.8 percentage of participants |
| Safety | Treatment Success Rates (At ≥ 5 Years) | PS Score <2.5 (n=53, 14, 67) | 92.9 percentage of participants |
| Safety | Treatment Success Rates (At ≥ 5 Years) | No additional surgery at index level(n=53, 14, 67) | 100.0 percentage of participants |
| Safety | Treatment Success Rates (At ≥ 5 Years) | Maintenance of distraction (n=42, 11, 53) | 90.9 percentage of participants |
| Safety | Treatment Success Rates (At ≥ 5 Years) | Treatment success rate (n=49, 13, 62) | 30.8 percentage of participants |
| Safety | Treatment Success Rates (At ≥ 5 Years) | SS improved >=0.5 point (n=52, 13, 65) | 84.6 percentage of participants |
| Safety | Treatment Success Rates (At ≥ 5 Years) | No device-related complication (n=53, 14, 67) | 100.0 percentage of participants |
| Total | Treatment Success Rates (At ≥ 5 Years) | PF improved >=0.5 point (n=52, 14, 66) | 68.2 percentage of participants |
| Total | Treatment Success Rates (At ≥ 5 Years) | SS improved >=0.5 point (n=52, 13, 65) | 60.0 percentage of participants |
| Total | Treatment Success Rates (At ≥ 5 Years) | Treatment success rate (n=49, 13, 62) | 38.7 percentage of participants |
| Total | Treatment Success Rates (At ≥ 5 Years) | PS Score <2.5 (n=53, 14, 67) | 83.6 percentage of participants |
| Total | Treatment Success Rates (At ≥ 5 Years) | No dislodgement of implant (n=43, 11, 54) | 96.3 percentage of participants |
| Total | Treatment Success Rates (At ≥ 5 Years) | Maintenance of distraction (n=42, 11, 53) | 94.3 percentage of participants |
| Total | Treatment Success Rates (At ≥ 5 Years) | No additional surgery at index level(n=53, 14, 67) | 95.5 percentage of participants |
| Total | Treatment Success Rates (At ≥ 5 Years) | No device-related complication (n=53, 14, 67) | 92.5 percentage of participants |
Secondary
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)
Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary \[PCS\] and mental component summary \[MCS\]). Scores for each subdomain and component summary range from 0 worst to 100 best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.
Time frame: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Physical Functioning (n=52, 14, 66) | 28.0 units on a scale | Standard Deviation 30 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Mental Health (n=52, 14, 66) | 3.8 units on a scale | Standard Deviation 19.5 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Role-Physical (n=50, 14, 64) | 28.5 units on a scale | Standard Deviation 51.8 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Vitality (n=52, 14, 66) | 7.9 units on a scale | Standard Deviation 25.2 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | PCS (n=49, 13, 62) | 8.6 units on a scale | Standard Deviation 10.4 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | General Health (n=52, 14, 66) | -5.4 units on a scale | Standard Deviation 14.1 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Bodily Pain (n=52, 14, 66) | 23.4 units on a scale | Standard Deviation 26.2 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Role-Emotional (n=50, 13, 63) | 24.0 units on a scale | Standard Deviation 58.7 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | MCS (n=49, 13, 62) | 3.9 units on a scale | Standard Deviation 12.6 |
| Target | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Social Functioning (n=52, 14, 66) | 32.0 units on a scale | Standard Deviation 34.9 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | PCS (n=49, 13, 62) | 11.6 units on a scale | Standard Deviation 9.2 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Bodily Pain (n=52, 14, 66) | 31.1 units on a scale | Standard Deviation 19.9 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | General Health (n=52, 14, 66) | -0.9 units on a scale | Standard Deviation 11.4 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | MCS (n=49, 13, 62) | 2.7 units on a scale | Standard Deviation 8.9 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Mental Health (n=52, 14, 66) | 3.4 units on a scale | Standard Deviation 10.9 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Physical Functioning (n=52, 14, 66) | 27.1 units on a scale | Standard Deviation 15.9 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Role-Emotional (n=50, 13, 63) | 35.9 units on a scale | Standard Deviation 44 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Role-Physical (n=50, 14, 64) | 50.0 units on a scale | Standard Deviation 42.7 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Social Functioning (n=52, 14, 66) | 15.2 units on a scale | Standard Deviation 23.1 |
| Safety | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Vitality (n=52, 14, 66) | 10.0 units on a scale | Standard Deviation 14.3 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Vitality (n=52, 14, 66) | 8.3 units on a scale | Standard Deviation 23.3 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Role-Emotional (n=50, 13, 63) | 26.5 units on a scale | Standard Deviation 55.9 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Bodily Pain (n=52, 14, 66) | 25.0 units on a scale | Standard Deviation 25.1 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Social Functioning (n=52, 14, 66) | 28.4 units on a scale | Standard Deviation 33.3 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Role-Physical (n=50, 14, 64) | 33.2 units on a scale | Standard Deviation 50.4 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Mental Health (n=52, 14, 66) | 3.7 units on a scale | Standard Deviation 17.9 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | MCS (n=49, 13, 62) | 3.7 units on a scale | Standard Deviation 11.9 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | PCS (n=49, 13, 62) | 9.2 units on a scale | Standard Deviation 10.2 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Physical Functioning (n=52, 14, 66) | 27.8 units on a scale | Standard Deviation 27.5 |
| Total | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | General Health (n=52, 14, 66) | -4.2 units on a scale | Standard Deviation 13.6 |
Secondary
Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)
ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). 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 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.
Time frame: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Target | Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | Mean Change in SS (n=52, 13, 65) | -0.8 units on a scale | Standard Deviation 0.9 |
| Target | Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | Mean change in PF (n=52, 14, 66) | -1.0 units on a scale | Standard Deviation 0.7 |
| Safety | Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | Mean Change in SS (n=52, 13, 65) | -1.0 units on a scale | Standard Deviation 0.5 |
| Safety | Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | Mean change in PF (n=52, 14, 66) | -0.4 units on a scale | Standard Deviation 0.4 |
| Total | Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | Mean Change in SS (n=52, 13, 65) | -0.8 units on a scale | Standard Deviation 0.8 |
| Total | Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | Mean change in PF (n=52, 14, 66) | -0.8 units on a scale | Standard Deviation 0.7 |
Secondary
Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)
ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores \<2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.
Time frame: 3+ years following first 2 years post-X-STOP implant through IDE study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Target | Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | 1.7 units on a scale | Standard Deviation 0.8 |
| Safety | Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | 1.5 units on a scale | Standard Deviation 0.6 |
| Total | Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | 1.6 units on a scale | Standard Deviation 0.7 |
Other Pre-specified
Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study
Time frame: 3+ years following first 2 years post-X-STOP implant through IDE study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Target | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Procedure related | 1 participants |
| Target | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Implant related | 0 participants |
| Target | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Implant & Procedure related | 2 participants |
| Target | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Not related | 15 participants |
| Target | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Undetermined | 3 participants |
| Safety | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Not related | 5 participants |
| Safety | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Implant related | 0 participants |
| Safety | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Procedure related | 0 participants |
| Safety | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Implant & Procedure related | 0 participants |
| Safety | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Undetermined | 0 participants |
| Total | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Implant & Procedure related | 2 participants |
| Total | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Implant related | 0 participants |
| Total | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Not related | 20 participants |
| Total | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Procedure related | 1 participants |
| Total | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Undetermined | 3 participants |
Other Pre-specified
Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study
The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.
Time frame: 3+ years following first 2 years post-X-STOP implant through IDE study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Target | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Supplemental Fixations | 0 participants |
| Target | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Removal | 3 participants |
| Target | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Re-operations | 0 participants |
| Target | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with other subsequent surgeries | 2 participants |
| Target | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Revision | 2 participants |
| Target | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Subsequent surgeries | 5 participants |
| Safety | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Removal | 0 participants |
| Safety | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Subsequent surgeries | 1 participants |
| Safety | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Revision | 0 participants |
| Safety | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Re-operations | 0 participants |
| Safety | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Supplemental Fixations | 0 participants |
| Safety | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with other subsequent surgeries | 1 participants |
| Total | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Revision | 2 participants |
| Total | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with other subsequent surgeries | 3 participants |
| Total | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Supplemental Fixations | 0 participants |
| Total | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Removal | 3 participants |
| Total | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Subsequent surgeries | 6 participants |
| Total | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | Number of Patients with Re-operations | 0 participants |