Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L™ artificial disc in the treatment of degenerative disc disease

BMC Surgery

Study Protocol

Fred F Mo¹  James J Yue¹ 

[1] Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, 800 Howard Ave, 06511, New Haven, CT, USA;

关键词: Disc Degeneration;    Disc Height;    Degenerative Disc Disease;    Spondylolysis;    Total Disc Replacement;   

DOI  :  10.1186/1471-2482-10-14

 received in 2009-10-08, accepted in 2010-04-09,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundThe 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/DesignThe 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.DiscussionThe 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.Trial RegistrationCurrent Controlled Trials NCT00589797.

【 授权许可】

CC BY   
© Yue and Mo; licensee BioMed Central Ltd. 2010