CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease
This study has been completed.
Information provided by:
First received: September 13, 2005
Last updated: September 14, 2005
Last verified: September 2005
No Study Results Posted on ClinicalTrials.gov for this Study
|Study Status:||This study has been completed.|
|Estimated Study Completion Date:||No date given|
|Estimated Primary Completion Date:||No date given|
Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, Garcia R Jr, Regan JJ, Ohnmeiss DD. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine. 2005 Jul 15;30(14):1565-75; discussion E387-91.
McAfee PC, Cunningham B, Holsapple G, Adams K, Blumenthal S, Guyer RD, Dmietriev A, Maxwell JH, Regan JJ, Isaza J. A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine. 2005 Jul 15;30(14):1576-83; discussion E388-90.
Geisler FH, Blumenthal SL, Guyer RD, McAfee PC, Regan JJ, Johnson JP, Mullin B. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine. 2004 Sep;1(2):143-54.