Clinical results of ProDisc-II lumbar total disc replacement: report from the United States clinical trial

Rick B Delamarter; Hyun W Bae; Ben B Pradhan

doi:10.1016/j.ocl.2005.03.004

Clinical results of ProDisc-II lumbar total disc replacement: report from the United States clinical trial

Orthop Clin North Am. 2005 Jul;36(3):301-13. doi: 10.1016/j.ocl.2005.03.004.

Authors

Rick B Delamarter¹, Hyun W Bae, Ben B Pradhan

Affiliation

¹ Spine Research Foundation, The Spine Institute at Saint John's Health Center, Suite 400, 1301 20th Street, Santa Monica, CA 90404, USA.

PMID: 15950690
DOI: 10.1016/j.ocl.2005.03.004

Abstract

The much-awaited clinical use of lumbar artificial discs has begun in the United States. The United States Investigational Device Exemption (US IDE) clinical trial of the ProDisc-II prosthetic disc (Synthes, Paoli, PA) was recently completed, with all indications that it meets or surpasses the test of equivalence against fusion controls. This is a review of the clinical performance of the ProDisc-II artificial disc and includes an interim report from the US IDE trial at one site.

Publication types

Comparative Study
Review

MeSH terms

Adult
Arthroplasty, Replacement / adverse effects
Arthroplasty, Replacement / methods*
Female
Follow-Up Studies
Humans
Intervertebral Disc Displacement / diagnostic imaging
Intervertebral Disc Displacement / surgery
Joint Prosthesis*
Lumbar Vertebrae / pathology
Lumbar Vertebrae / surgery*
Male
Middle Aged
Multicenter Studies as Topic
Pain Measurement
Prospective Studies
Prosthesis Design
Radiography
Randomized Controlled Trials as Topic
Range of Motion, Articular / physiology*
Recovery of Function
Risk Assessment
Spinal Osteophytosis / diagnostic imaging
Spinal Osteophytosis / surgery*
Treatment Outcome
United States