Clinical results of ProDisc-II lumbar total disc replacement: report from the United States clinical trial.
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.
Delamarter
Rick B
RB
Spine Research Foundation, The Spine Institute at Saint John's Health Center, Suite 400, 1301 20th Street, Santa Monica, CA 90404, USA.
Bae
Hyun W
HW
Pradhan
Ben B
BB
D000328:Adult; D019643:Arthroplasty, Replacement / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000000981:diagnostic imaging / Q000601:surgery; D007595:Joint Prosthesis; D008159:Lumbar Vertebrae / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010147:Pain Measurement; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D016032:Randomized Controlled Trials as Topic; D016059:Range of Motion, Articular / Q000502:physiology*; D020127:Recovery of Function; D018570:Risk Assessment; D013128:Spinal Osteophytosis / Q000000981:diagnostic imaging / Q000601:surgery*; D016896:Treatment Outcome; D014481:United States