Spine Clinical Trials

Treatment of Lumbar Spinal Stenosis With X-STOP® PEEK Spacer in Moderately Symptomatic Patients: Condition of Approval Study (COAST)

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.

Principal Investigator: M.R. Chambers, DVM, MD
ClinicalTrials.gov Identifier: NCT00517751


Mark N. Hadley, MD

Patrick R. Pritchard, MD

Mamerhi O. Okor, MD

M.R. Chambers, DVM, MD


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