Jack E. Zigler

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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)
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)
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)
There is an increasing population of immunocompromised patients with HIV, IV drug abuse, organ transplantation, and long-term steroid treatment developing spinal infections. Delayed diagnosis because of blunted host immune response and lack of outward signs and symptoms places the treating physician at a disadvantage in the treatment of this type 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)
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 Disc replacement arthroplasty previously has been shown to be an effective alternative to spine fusion for the treatment of single-level lumbar degenerative disc disease. The purpose of the present study was to determine the twenty-four-month results of a clinical trial of the ProDisc-L total disc replacement as compared with spinal fusion for(More)
OBJECT The authors report the 5-year results for radiographically demonstrated adjacent-level degenerative changes from a prospective multicenter study in which patients were randomized to either total disc replacement (TDR) or circumferential fusion for single-level lumbar degenerative disc disease (DDD). METHODS Two hundred thirty-six patients with(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)