Condition of Approval Study

Phase 4TerminatedNCT00517751

Medtronic Spine LLC176 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

Lumbar Spinal Stenosis

Interventions

X-STOP PEEKDEVICE

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. has a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire 2. is 50 years old or older 3. 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. 4. can sit for 50 minutes without pain 5. can walk 50 feet or more 6. 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 7. 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 8. has signed a patient informed consent document 9. is physically and mentally willing and able or has a caregiver who can comply with the postoperative and routinely scheduled clinical and radiographic evaluations 10. 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: 1. has a baseline score less than or equal to 2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire 2. cannot sit for 50 minutes 3. cannot walk more than 50 feet 4. has unremitting pain in any spinal position 5. has axial back pain only without leg/buttock/groin pain 6. has a fixed motor deficit 7. has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction 8. has severe symptomatic lumbar spinal stenosis at more than two levels 9. 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) 10. has an ankylosed segment at the affected level(s); 11. has significant scoliosis (Cobb angle is greater than 25 degrees) 12. has an acute fracture of the spinous process or pars interarticularis 13. has sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and /or hips 14. 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 15. has Paget's disease at the involved segment(s) or metastasis to the vertebrae 16. has had any surgery of the lumbar spine 17. has significant peripheral neuropathy demonstrated by nerve conduction velocity tests 18. has acute denervation secondary to radiculopathy, as shown by EMG 19. has significant peripheral vascular disease characterized by diminished dorsalis pedus or tibial pulses 20. has extreme obesity as defined by a Body Mass Index (BMI) greater than 40 kg/m2 21. has an active systemic infection or infection localized to the site of implantation 22. has an active systemic disease such as AIDS, HIV, hepatitis, etc. 23. 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) 24. has a recent history of narcotic abuse (i.e., within last 3 years) 25. has a known allergy to titanium,titanium alloy, or polyetheretherketone 26. is immunologically suppressed, or has received or is receiving steroids at any dose daily for more than one month within the last 12 months 27. is currently involved in a study of another investigational product that may affect the outcome of this study 28. is pregnant or planning to become pregnant during the study period 29. cannot undergo MRI or tolerate closed MRI scanning.

Locations (23)

The Kirklin Clinic - UAB Medical

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Treatment Success Rate at 24 Months

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

Time frame: 24 months

Secondary Outcomes

Treatment Success Rate at 60 Months

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

Time frame: 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.

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

Data from ClinicalTrials.gov

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