Condition of Approval Study (COAST)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Lumbar Spinal Stenosis With X-STOP® PEEK Spacer in Moderately Symptomatic Patients|
- Treatment response rates equivalent to overall success reported in the IDE pivotal trial as measured by improvement in ZCQ scores, no additional surgery for LSS, maintenance of distraction, no dislodgement of the implant or device related complications. [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Secondary endpoints: SF-36, ODI, and NRS scores, Adverse event rate,device failures, MRI evaluation of adjacent levels and secondary surgeries. [ Time Frame: Two to Five years ] [ Designated as safety issue: No ]
- Treatment response rates at 5 years as measured by ZCQ, no additional LSS surgery, maintenance of distraction, no dislodgement or device complications. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||July 2019 (Final data collection date for primary outcome measure)|
Experimental: X-STOP PEEK
In this arm, patients will undergo X-STOP PEEK surgery.
Device: X-STOP PEEK
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517751
|Contact: Clinical Department||1800-876-3133 ext firstname.lastname@example.org|
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|Principal Investigator:||Jim Malcolm, MD||Pinnacle Orthopedics|