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


Personnel

Mark N. Hadley, MD

Patrick R. Pritchard, MD

Mamerhi O. Okor, MD

M.R. Chambers, DVM, MD


Publications

Hadley MN. (Editorial) Metastatic spinal cord tumors. J Neurosurg Spine, 11(1):53-55, 2009.

Pryputniewicz D, Moore TA II, Hadley, MN. The Far-Lateral Extracavitary Approach to the Thoracic Spine and Spinal Cord. J Neurosurgery: Spine, in review, 2010.

Moore TA, Wolff CL, Hadi BA, Hadley MN. Blood loss during thoracolumbar stabilization and fusion procedures. In reivew: Neurosurgery, May 2010.

Hadley MN, McKibben M. Ethical and Medicolegal Aspects of Spinal Surgery. In:Spine Surgery: Techniques, Complication Avoidance, and Management (Third Edition), Benzel EC (ed), Elsevier, 2010.

Pryputniewicz DM, Hadley MN. Axis Fractures, Neurosurgery 66(3Suppl.):68-82, 2010.