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

Foreman PM, Markert JM, Diethelm AG, Hadley MN. The History of Neurosurgery at the University of Alabama at Birmingham. Neurosurgery, 75(4): (In press) October 2014.

Griessenauer CJ, Bauer DF, Moore TA 2nd, Pritchard PR, Hadley MN. Surgical manifestations of thoracic arachnoid pathology: series of 28 cases. Journal of Neurosurgery: Spine. (Epub ahead of print 2013 Nov 8.) 2014 Jan 20(1) PMID 24206032

Hadley MN, Walters BC, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Rozzelle CJ, Ryken TC, Theodore N. Chapter 4, Clinical Assessment Following Acute Cervical Spinal Cord Injury. In: Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries: Neurosurgery, 72:3(Supplement), 40-53, 2013. PMID 23417178

Hadley MN, Walters BC, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Rozzelle CJ, Ryken TC, Theodore N. Chapter 8, Pharmacological Therapy for Acute Spinal Cord Injury. In: Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries: Neurosurgery, 72:3(Supplement), 93-105, 2013.PMID 23417182

Hadley MN, Walters BC, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Rozzelle CJ, Ryken TC, Theodore N. Chapter 17, Management of Acute Traumatic Central Cord Syndrome (ATCCS). In: Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries: Neurosurgery, 72:3(Supplement), 195-204, 2013. PMID 23417191

Hadley MN, Walters BC, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Rozzelle CJ, Ryken TC, Theodore N. Chapter 20, Management of Vertebral Artery Injuries Following Non-penetrating Cervical Trauma. In: Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries: Neurosurgery, 72:3(Supplement), 234-243, 2013. PMID 23417194

Walters BC, Hadley MN. Guidelines for GM-1 treatment in acute spinal cord injury: In reply. Neurosurgery. 2013 Aug; 73(2):E384-386. PMID 23624417

Miller JH, Zywicke HA, Fleming JB, Griessenauer CJ, Whisenhunt TR, Okor MO, Harrigan MR, Pritchard PR, Hadley MN. Neurosurgical injuries resulting from the 2011 tornados in Alabama: the experience at the University of Alabama at Birmingham Medical Center. Journal of Neurosurgery, 2013 Jun 118(6):1356-1362. Epub 2013 Apr 23. PMID 23611044

Hadley MN. (Editorial) No increased risk?. Journal of Neurosurgery: Spine. 2013 Feb 18(2):122-124, discussion 124-125. Epub 2012 Dec 11. PMID 23231360.

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