Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L artificial disc in the treatment of degenerative disc disease.
BACKGROUND
The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control (the Charité Artificial Disc [DePuy Spine] or ProDisc-L Total Disc Replacement [Synthes Spine]) with respect to the rate of individual subject success at 24 months. Individual subject success is a composite of effectiveness and safety.


METHODS
The study proposed is a prospective, randomized, single-masked, controlled, multi-center clinical trial consisting of an estimated 414 subjects with single-level DDD of the lumbar spine (L4/L5, or L5/S1) who have failed to improve with conservative treatment for at least six months prior to enrollment. After enrollment, subjects will be randomized in a 2:1 ratio to either the Activ-L Disc (investigational device) or the control (Charité or ProDisc-L). Radiographic endpoints will be evaluated by an independent reviewer at an imaging core laboratory. Each subject will be followed for 5 years post-treatment.


CONCLUSIONS
The safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine will be equivalent to Charité Artificial Disc [DePuy Spine] or ProDisc-L Total Disc Replacement [Synthes Spine] at 24 months.


BACKGROUND
Current Controlled Trials NCT00589797.
Yue
James J
JJ
Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, 800 Howard Ave, New Haven, CT06511, USA. james.yue@yale.edu
Mo
Fred F
FF
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants; D019919:Prosthesis Implantation / Q000379:methods; D016037:Single-Blind Method; D016896:Treatment Outcome