Condition of Approval Study

Study Overview
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Brief Summary
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This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline (i.e., an indicated population) who elect to undergo X STOP PEEK surgery.

Detailed Description
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This prospective, multicenter longitudinal five-year study of X-STOP PEEK implant usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline (i.e., an indicated population) who elect to undergo X-STOP PEEK surgery. This post-approval study will enroll 240 patients at up to 8 clinical sites where all participating spine surgeons have completed a company-sponsored physician training program. The clinical sites recruited to participate in this study comprise a geographically diverse mix of academic, referral, and/or community based sites. Safety and effectiveness data will be assessed at baseline and annually through five (5) years postoperatively. Office visits will be scheduled preoperatively, and at 6 weeks, 1, 2, 3, 4, and 5 years postoperatively. Clinical/neurological and radiographic examination will be performed during each office visit. A baseline patient history (including medication usage) will be taken, and concomitant medications will be recorded at each postoperative follow-up visit. In addition, patients will be asked to complete the following questionnaires prior to consultation with their physicians or their staff: Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and SF-36 Health Survey. At the 2-, 3-, 4- and 5-year office visit, patients will also be asked two questions assessing the value of surgery and the overall improvement in the quality of life postoperatively. The primary study endpoint in this study is treatment success. Secondary endpoints will include scores from the SF-36, ODI, and NRS, as well as incidence rates of adverse events, device failures, and secondary surgeries.

Official Title
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Treatment of Lumbar Spinal Stenosis With X-STOP® PEEK Spacer in Moderately Symptomatic Patients

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: X-STOP PEEK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: has a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire is 50 years old or older has leg/buttock/groin pain with or without back pain NOTE: Leg/buttock/groin pain must be completely relieved when flexed such as when sitting in a chair. If back pain is also present, it must be partially relieved when flexed. can sit for 50 minutes without pain can walk 50 feet or more has a confirmed diagnosis of neurogenic intermittent claudication secondary to lumbar spinal stenosis, with X-Ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing has completed at least six months of conservative care therapy which may include but is not limited to physical therapy, bracing, systemic or injected medications has signed a patient informed consent document is physically and mentally willing and able or has a caregiver who can comply with the postoperative and routinely scheduled clinical and radiographic evaluations lives in the immediate area and has no plans to relocate to another geographic area before completion of the study or lives outside the immediate area and will comply with the scheduled postoperative visits with a prearranged and designated physician Exclusion Criteria: has a baseline score less than or equal to 2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire cannot sit for 50 minutes cannot walk more than 50 feet has unremitting pain in any spinal position has axial back pain only without leg/buttock/groin pain has a fixed motor deficit has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction has severe symptomatic lumbar spinal stenosis at more than two levels has significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1 to 4) has an ankylosed segment at the affected level(s); has significant scoliosis (Cobb angle is greater than 25 degrees) has an acute fracture of the spinous process or pars interarticularis has sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and /or hips has severe osteoporosis of the spine or hip, defined as bone mineral density (BMD) in the spine or hip more than 2.5 SD below the mean of adult normals in the presence of one or more fragility fractures has Paget's disease at the involved segment(s) or metastasis to the vertebrae has had any surgery of the lumbar spine has significant peripheral neuropathy demonstrated by nerve conduction velocity tests has acute denervation secondary to radiculopathy, as shown by EMG has significant peripheral vascular disease characterized by diminished dorsalis pedus or tibial pulses has extreme obesity as defined by a Body Mass Index (BMI) greater than 40 kg/m2 has an active systemic infection or infection localized to the site of implantation has an active systemic disease such as AIDS, HIV, hepatitis, etc. has a medical condition that may interfere with postoperative management and follow-up, or may result in patient death prior to study completion (e.g., Alzheimer's disease, unstable cardiac disease, active malignancy) has a recent history of narcotic abuse (i.e., within last 3 years) has a known allergy to titanium,titanium alloy, or polyetheretherketone is immunologically suppressed, or has received or is receiving steroids at any dose daily for more than one month within the last 12 months is currently involved in a study of another investigational product that may affect the outcome of this study is pregnant or planning to become pregnant during the study period cannot undergo MRI or tolerate closed MRI scanning.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: X-STOP PEEK<br>In this arm, patients will undergo X-STOP PEEK surgery. | Device: X-STOP PEEK<br>* Placement of X-STOP PEEK in up to two levels in the lumbar spine for patients diagnosed with moderately symptomatic lumbar spinal stenosis in accordance with current labeling instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success Rate at 24 Months | Treatment success rate is reported as the percentage of participants who met all of the following criteria: 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 Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5 No additional surgery for lumbar stenosis performed Maintenance of distraction No dislodgement of the implant No device-related complications | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success Rate at 60 Months | Treatment success rate is reported as the percentage of participants who met all of the following criteria: Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5 No additional surgery for lumbar stenosis performed Maintenance of distraction No dislodgement of the implant No device-related complications | 60 months | 
| Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) | 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. | Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 
| Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ) | 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. | 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months | 
| Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ) | 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. | Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 
| Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ) | 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. | 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months | 
| Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment | 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. | 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 
| Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment | 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. | 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months | 
| Oswestry Disability Index (ODI) Score | 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). | Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 
| General Health Status -- SF-36 PCS | 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. | Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 
| General Health Status -- SF-36 MCS | MCS score is between 0 and 100, with higher scores denoting better quality of life. | Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 
| Back Pain in Numerical Rating Scales (NRS) | 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. | Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 
| Left Leg Pain in Numerical Rating Scales (NRS) | 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. | Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 
| Right Leg Pain in Numerical Rating Scales (NRS) | 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. | Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Spinal Stenosis, X-STOP Spacer, Interspinous process decompression, Neurogenic Intermittent Claudication