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STUDY DESIGN A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. OBJECTIVE To evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1(More)
STUDY DESIGN Randomized controlled trial. OBJECTIVE Analyze the clinical outcomes at 5 years comparing cervical total disc replacement (TDR) with ProDisc-C (Synthes Spine USA Products; LLC, West Chester, PA) with anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA Previous reports of 2- and 4-year results have shown that(More)
BACKGROUND CONTEXT Cervical total disc replacement (TDR) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease (SCDD). PURPOSE The purpose of this trial is to compare the safety and efficacy of cervical TDR, ProDisc-C (Synthes Spine Company, L.P., West Chester,(More)
This study represents the first 39 patients with at least 6-month follow-up enrolled in a prospective randomized Food and Drug Administration study evaluating the safety and efficacy of the ProDisc II versus the control, a 360 degrees lumbar spinal fusion. Data were collected preoperatively and at 6 weeks, 3 months, and 6 months postoperatively. Visual(More)
STUDY DESIGN Prospective randomized clinical trial. OBJECTIVE Determine the reasons for, and rates of, secondary surgical intervention up to 5 years at both the index and adjacent levels in patients treated with cervical total disc replacement (TDR) or anterior cervical discectomy and fusion (ACDF). Patients undergoing TDR received ProDisc-C. SUMMARY OF(More)
BACKGROUND In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical(More)
OBJECT The purpose of this study was to evaluate the long-term safety and effectiveness of the ProDisc-L total disc replacement (TDR) as part of an FDA-mandated postmarket approval study. This report summarizes the clinical findings after 5 years of follow-up. METHODS Two hundred thirty-six patients were treated and followed up for 5 years; 161 TDRs and(More)
INTRODUCTION If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following(More)
  • Jack E Zigler
  • 2004
The ProDisc was developed by Thierry Marnay, a French orthopedic surgeon, in the late 1980s. Marnay and his associate implanted ProDiscs into 64 patients from 1990 to 1993. Demonstrating remarkable intellectual restraint, he let this cohort of patients "incubate" so he could see their progress before performing any additional implantations. In 1998, 61 of(More)
STUDY DESIGN This study is based on a review of the literature related to the use of the ProDisc device and a report of the preliminary results of a prospective randomized study. OBJECTIVES To review European results related to the use of the ProDisc device and compare the results of this device to lumbar fusion in a prospective, randomized study being(More)