Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

被引:122
作者
Radcliff, Kris [1 ]
Coric, Domagoj [2 ]
Albert, Todd [3 ]
机构
[1] Thomas Jefferson Univ, Rothman Inst, Dept Orthoped Surg, 2500 English Creek Ave, Egg Harbor, NJ 08234 USA
[2] Carolinas Med Ctr, Carolina Neurosurg & Spine Associates, Charlotte, NC 28203 USA
[3] Hosp Special Surg, Weill Cornell Med Coll, New York, NY USA
关键词
cervical disc herniation; cervical radiculopathy; cervical disc replacement; cervical arthroplasty; ADJACENT SEGMENT PATHOLOGY; FOLLOW-UP; META-ANALYSIS; PRODISC-C; ARTHROPLASTY; OUTCOMES; RATES; ARTHRODESIS; KINEMATICS; ARTICLE;
D O I
10.3171/2015.12.SPINE15824
中图分类号
R74 [神经病学与精神病学];
学科分类号
100204 [神经病学];
摘要
OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor. RESULTS A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups. CONCLUSIONS Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients.
引用
收藏
页码:213 / 224
页数:12
相关论文
共 41 条
[1]
Kinematics of the Cervical Adjacent Segments After Disc Arthroplasty Compared With Anterior Discectomy and Fusion A Systematic Review and Meta-Analysis [J].
Anderson, Paul A. ;
Sasso, Rick C. ;
Hipp, John ;
Norvell, Daniel C. ;
Raich, Annie ;
Hashimoto, Robin .
SPINE, 2012, 37 (22) :S85-S95
[2]
Segmental Contribution Toward Total Cervical Range of Motion A Comparison of Cervical Disc Arthroplasty and Fusion [J].
Auerbach, Joshua D. ;
Anakwenze, Okechukwu A. ;
Milby, Andrew H. ;
Lonner, Baron S. ;
Balderston, Richard A. .
SPINE, 2011, 36 (25) :E1593-E1599
[3]
Cervical disc prosthesis versus arthrodesis using one-level, hybrid and two-level constructs: an in vitro investigation [J].
Barrey, Cedric ;
Campana, Sophie ;
Persohn, Sylvain ;
Perrin, Gilles ;
Skalli, Wafa .
EUROPEAN SPINE JOURNAL, 2012, 21 (03) :432-442
[4]
Intermediate clinical and radiological results of cervical TDR (Mobi-C®) with up to 2 years of follow-up [J].
Beaurain, J. ;
Bernard, P. ;
Dufour, T. ;
Fuentes, J. M. ;
Hovorka, I. ;
Huppert, J. ;
Steib, J. P. ;
Vital, J. M. ;
Aubourg, L. ;
Vila, T. .
EUROPEAN SPINE JOURNAL, 2009, 18 (06) :841-850
[5]
Boselie TF, 2012, COCHRANE DB SYST REV, V9
[6]
A systematic review of randomized trials on the effect of cervical disc arthroplasty on reducing adjacent-level degeneration [J].
Botelho, Ricardo Vieira ;
dos Santos Moraes, Osmar Jose ;
Fernandes, Gustavo Alberto ;
Buscariolli, Yuri dos Santos ;
Bernardo, Wanderley Marques .
NEUROSURGICAL FOCUS, 2010, 28 (06) :1-11
[7]
Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial [J].
Burkus, J. Kenneth ;
Traynelis, Vincent C. ;
Haid, Regis W., Jr. ;
Mummaneni, Praveen V. .
JOURNAL OF NEUROSURGERY-SPINE, 2014, 21 (04) :516-528
[8]
Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial Presented at the 2009 Joint Spine Section Meeting Clinical article [J].
Burkus, J. Kenneth ;
Haid, Regis W., Jr. ;
Traynelis, Vincent C. ;
Mummaneni, Praveen V. .
JOURNAL OF NEUROSURGERY-SPINE, 2010, 13 (03) :308-318
[9]
Multilevel cervical arthroplasty with artificial disc replacement [J].
Cardoso, Mario J. ;
Rosner, Michael K. .
NEUROSURGICAL FOCUS, 2010, 28 (05) :1-6
[10]
Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the KineflexIC artificial disc investigational device exemption study with a minimum 2-year follow-up Clinical article [J].
Coric, Domagoj ;
Nunley, Pierce D. ;
Guyer, Richard D. ;
Musante, David ;
Carmody, Cameron N. ;
Gordon, Charles R. ;
Lauryssen, Carl ;
Ohnmeiss, Donna D. ;
Boltes, Margaret O. .
JOURNAL OF NEUROSURGERY-SPINE, 2011, 15 (04) :348-358