Cervical Disc Arthroplasty: Rationale, Designs, and Results of Randomized Controlled Trials

被引:0
作者
Robertson, Djani M. [1 ]
Ton, Andy [2 ]
Brown, Michael [2 ]
Shahrestani, Shane [2 ,3 ]
Mills, Emily S. [2 ]
Wang, Jeffrey C. [2 ]
Hah, Raymond J. [2 ]
Alluri, Ram K. [2 ]
机构
[1] NYU, Langone Med Ctr, Dept Orthoped Surg, New York, NY USA
[2] Keck Med Ctr USC, Dept Orthopaed Surg, 1450 San Pablo St,HC4 Suite 5400, Los Angeles, CA 90033 USA
[3] CALTECH, Dept Med Engn, Pasadena, CA USA
关键词
cervical; cervical disc arthroplasty; cervical disc replacement; anterior cervical discectomy and fusion; degenerative disc disease; myelopathy; 7-YEAR FOLLOW-UP; INVESTIGATIONAL DEVICE EXEMPTION; LONG-TERM OUTCOMES; ARTIFICIAL DISC; SINGLE-LEVEL; HETEROTOPIC OSSIFICATION; CLINICAL-OUTCOMES; MOBI-C; COST-EFFECTIVENESS; REPLACEMENT;
D O I
10.14444/8586
中图分类号
R61 [外科手术学];
学科分类号
摘要
Background: This review outlines clinical data and characteristics of current Food and Drug Administration (FDA)- approved implants in cervical disc replacement/cervical disc arthroplasty (CDR/CDA) to provide a centralized resource for spine surgeons. Methods: Randomized controlled trials (RCTs) on CDR/CDA were identified using a search of the PubMed, Web of Science, and Google Scholar databases. The initial search identified 69 studies. Duplicates were removed, and the following inclusion criteria were applied when determining eligibility of RCTs for the current review: (1) discussing CDR/CDA prosthesis and (2) published within between 2010 and 2020. Studies without clinical data or that were not RCTs were excluded. All articles were reviewed independently by 2 authors, with the involvement of an arbitrator to facilitate consensus on any discrepancies. Results: A total of 34 studies were included in the final review. Findings were synthesized into a comprehensive table describing key features and clinical results for each FDA- approved CDR/CDA implant and are overall suggestive of expanding indications and increasing utilization. Conclusions: RCTs have provided substantial evidence to support CDR/CDA for treating single- and 2- level cervical degenerative disc disease in place of conventional anterior cervical discectomy and fusion. Clinical Relevance: This review provides a resource that consolidates relevant clinical data for current FDA- approved implants to help spine surgeons make an informed decision during preoperative planning. Level of Evidence: 5
引用
收藏
页码:258 / 276
页数:20
相关论文
共 63 条
[1]   The Mobi-C cervical disc for one-level and two-level cervical disc replacement: a review of the literature [J].
Alvin, Matthew D. ;
Mroz, Thomas E. .
MEDICAL DEVICES-EVIDENCE AND RESEARCH, 2014, 7 :397-403
[2]   History of cervical disc arthroplasty [J].
Baaj, Ali A. ;
Uribe, Juan S. ;
Vale, Fernando L. ;
Preul, Mark C. ;
Crawford, Neil R. .
NEUROSURGICAL FOCUS, 2009, 27 (03) :E10.1-E10.7
[3]   The Mobi-C® cervical disc and other devices for two-level disc replacement: overview of its safety and efficacy [J].
Badve, Siddharth A. ;
Kurra, Swamy ;
Nunley, Pierce D. ;
Lavelle, William F. .
EXPERT REVIEW OF MEDICAL DEVICES, 2019, 16 (04) :307-315
[4]   Hybrid Anterior Cervical Discectomy and Fusion and Cervical Disc Arthroplasty: An Analysis of Short-Term Complications, Reoperations, and Readmissions [J].
Boddapati, Venkat ;
Lee, Nathan J. ;
Mathew, Justin ;
Vulapalli, Meghana M. ;
Lombardi, Joseph M. ;
Dyrszka, Marc D. ;
Sardar, Zeeshan M. ;
Lehman, Ronald A. ;
Riew, K. Daniel .
GLOBAL SPINE JOURNAL, 2021, 11 (08) :1183-1189
[5]   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
[6]   Radiological and clinical outcomes of 3-level cervical disc arthroplasty [J].
Chang, Hsuan-Kan ;
Huang, Wen-Cheng ;
Tu, Tsung-Hsi ;
Fay, Li-Yu ;
Kuo, Chao-Hung ;
Chang, Chih-Chang ;
Wu, Ching-Lan ;
Lirng, Jiing-Feng ;
Wu, Jau-Ching ;
Cheng, Henrich ;
Hsu, Shih-Ming .
JOURNAL OF NEUROSURGERY-SPINE, 2020, 32 (02) :174-181
[7]   Prevalence of heterotopic ossification after cervical total disc arthroplasty: a meta-analysis [J].
Chen, Jian ;
Wang, Xinwei ;
Bai, Wanshan ;
Shen, Xiaolong ;
Yuan, Wen .
EUROPEAN SPINE JOURNAL, 2012, 21 (04) :674-680
[8]   Superiority of the BryanA® Disc Prosthesis for Cervical Myelopathy: A Randomized Study with 3-year Followup [J].
Cheng, Lei ;
Nie, Lin ;
Li, Mu ;
Huo, Yong ;
Pan, Xin .
CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 2011, 469 (12) :3408-3414
[9]   Fusion versus Bryan Cervical Disc in two-level cervical disc disease: a prospective, randomised study [J].
Cheng, Lei ;
Nie, Lin ;
Zhang, Li ;
Hou, Yong .
INTERNATIONAL ORTHOPAEDICS, 2009, 33 (05) :1347-1351
[10]   Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site - Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2005 [J].
Coric, D ;
Finger, F ;
Boltes, P .
JOURNAL OF NEUROSURGERY-SPINE, 2006, 4 (01) :31-35