Complications of lumbar artificial disc replacement compared to fusion: results from the prospective, randomized, multicenter US Food and Drug Administration …
RT Holt, ME Majd, JE Isaza, SL Blumenthal, PC McAfee… - SAS journal, 2007 - Elsevier
BACKGROUND: Previous reports of lumbar total disc replacement (TDR) have described
significant complications. The US Food and Drug Administration (FDA) investigational …
significant complications. The US Food and Drug Administration (FDA) investigational …
A prospective, randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc replacement with the CHARITE™ …
S Blumenthal, PC McAfee, RD Guyer, SH Hochschuler… - 2005 - journals.lww.com
Study Design. A prospective, randomized, multicenter, Food and Drug Administration-
regulated Investigational Device Exemption clinical trial. Objectives. The purpose of this …
regulated Investigational Device Exemption clinical trial. Objectives. The purpose of this …
A prospective, randomized, multicenter food and drug administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ™ …
PC McAfee, B Cunningham, G Holsapple, K Adams… - 2005 - journals.lww.com
Study Design. A prospective, randomized, multicenter, Food and Drug Administration-
regulated, investigational device exemption clinical trial. Objectives. To compare the safety …
regulated, investigational device exemption clinical trial. Objectives. To compare the safety …
Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a …
FH Geisler, SL Blumenthal, RD Guyer… - … of Neurosurgery: Spine, 2004 - thejns.org
Object. Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc
disease (DDD). Solid fusion, however, can cause stress and increased motion in the …
disease (DDD). Solid fusion, however, can cause stress and increased motion in the …
Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE …
RD Guyer, PC McAfee, RJ Banco, FD Bitan… - The Spine Journal, 2009 - Elsevier
BACKGROUND CONTEXT: The CHARITÉ artificial disc, a lumbar spinal arthroplasty device,
was approved by the United States Food and Drug Administration in 2004 based on two …
was approved by the United States Food and Drug Administration in 2004 based on two …
Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow …
RD Guyer, K Pettine, JS Roh, TA Dimmig, D Coric… - 2014 - journals.lww.com
Study Design. This was a prospective, randomized, controlled multicenter study with 24-
month follow-up. Objective. The purpose of this study was to evaluate the safety and efficacy …
month follow-up. Objective. The purpose of this study was to evaluate the safety and efficacy …
Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study
MF Gornet, JK Burkus, RF Dryer, JH Peloza… - … of Neurosurgery: Spine, 2019 - thejns.org
OBJECTIVE Despite evidence of its safety and effectiveness, the use of lumbar disc
arthroplasty has been slow to expand due in part to concerns about late complications and …
arthroplasty has been slow to expand due in part to concerns about late complications and …
Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the investigational device exemption study of the Charite Artificial …
JJ Regan, PC McAfee, SL Blumenthal, RD Guyer… - Spine, 2006 - journals.lww.com
Study Design. A prospective, randomized, multicenter, Food and Drug Administration
regulated Investigational Device Exemption (IDE) clinical trial. Objectives. To discern …
regulated Investigational Device Exemption (IDE) clinical trial. Objectives. To discern …
Results of the prospective, randomized, multicenter food and drug administration investigational device exemption study of the ProDisc®-L total disc replacement …
J Zigler, R Delamarter, JM Spivak, RJ Linovitz… - 2007 - journals.lww.com
Study Design. A prospective, randomized, multicenter, Food and Drug Administration-
regulated Investigational Device Exemption clinical trial. Objective. To evaluate the safety …
regulated Investigational Device Exemption clinical trial. Objective. To evaluate the safety …
Prospective, randomized, multicenter FDA IDE study of CHARITÉ artificial disc versus lumbar fusion: effect at 5-year follow-up of prior surgery and prior discectomy on …
FH Geisler, PC McAfee, RJ Banco, SL Blumenthal… - SAS journal, 2009 - Elsevier
BACKGROUND: Candidates for spinal arthrodesis or arthroplasty often present with a
history of prior surgery such as laminectomy, laminotomy or discectomy. In this study, lumbar …
history of prior surgery such as laminectomy, laminotomy or discectomy. In this study, lumbar …