Comparison of the more than 5-year clinical outcomes of cervical disc arthroplasty versus anterior cervical discectomy and fusion: A protocol for a systematic review and meta-analysis of prospective randomized controlled trials

Min-Min Shao, Chun-Hui Chen, Zhong-Ke Lin, Xiang-Yang Wang, Qi-Shan Huang, Yong-Long Chi, Ai-Min Wu, Min-Min Shao, Chun-Hui Chen, Zhong-Ke Lin, Xiang-Yang Wang, Qi-Shan Huang, Yong-Long Chi, Ai-Min Wu

Abstract

Background: Anterior cervical discectomy and fusion (ACDF) was almost the "golden standard" technique in treatment of symptomatic cervical degenerative disc disease, however, it cause motion loss of the indexed level, increase the intradiscal pressure and motion of the adjacent levels, and may accelerate the degeneration of adjacent level. Cervical disc arthroplasty (CDA) was designed to preserve the motion of index level, avoid the over-activity of adjacent levels and reduce the degeneration of adjacent disc levels, the process of degeneration of adjacent level is very slowly, long term follow up studies should be conducted, this study aim to compare the more than 5 years' long-term clinical outcomes and safety between CDA and ACDF.

Methods: A systematic review and meta-analysis that will be performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). The electric database of Medline, Embase, and Cochrane library will be systematic search. A standard data form will be used to extract the data of included studies. We will assess the studies according to the Cochrane Handbook for Systematic Reviews of Interventions, and perform analysis in software STATA 12.0. Fixed-effects models will be used for homogeneity data, while random-effects will be used for heterogeneity data. The overall effect sizes will be determined as weighted mean difference (WMD) for continuous outcomes and Relative risk (RR) for dichotomous outcomes.

Results: The results of study will be disseminated via both international conference and peer-review journal.

Conclusion: The conclusion of our study will provide the long-term and updated evidence of clinical outcomes and safety between CDA and ACDF, and help surgeon to change better surgical technique for patients.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

References

    1. Schimandle JH, Heller JG. Nonoperative treatment of degenerative cervical disk disease. J South Orthop Assoc 1996;5:207–12.
    1. Alvin MD, Qureshi S, Klineberg E, et al. Cervical degenerative disease: systematic review of economic analyses. Spine 2014;39(22 suppl 1):S53–64.
    1. Huang ZY, Wu AM, Li QL, et al. Comparison of two anterior fusion methods in two-level cervical spondylosis myelopathy: a meta-analysis. BMJ Open 2014;4:e004581.
    1. Albert TJ, Murrell SE. Surgical management of cervical radiculopathy. J Am Acad Orthop Surg 1999;7:368–76.
    1. Boyce RH, Wang JC. Evaluation of neck pain, radiculopathy, and myelopathy: imaging, conservative treatment, and surgical indications. Instr Course Lect 2003;52:489–95.
    1. Ba Z, Zhao W, Wu D, et al. Box cages packed with local decompression bone were efficient in anterior cervical discectomy and fusion: five- to 10-year follow-up. Spine 2012;37:E1260–3.
    1. Song KJ, Choi BY. Current concepts of anterior cervical discectomy and fusion: a review of literature. Asian Spine J 2014;8:531–9.
    1. Lied B, Roenning PA, Sundseth J, et al. Anterior cervical discectomy with fusion in patients with cervical disc degeneration: a prospective outcome study of 258 patients (181 fused with autologous bone graft and 77 fused with a PEEK cage). BMC Surg 2010;10:10.
    1. Hilibrand AS, Carlson GD, Palumbo MA, et al. Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am 1999;81:519–28.
    1. Ishihara H, Kanamori M, Kawaguchi Y, et al. Adjacent segment disease after anterior cervical interbody fusion. Spine J 2004;4:624–8.
    1. Kelly MP, Mok JM, Frisch RF, et al. Adjacent segment motion after anterior cervical discectomy and fusion versus Prodisc-c cervical total disk arthroplasty: analysis from a randomized, controlled trial. Spine 2011;36:1171–9.
    1. Rosenthal P, Kim KD. Cervical adjacent segment pathology following fusion: Is it due to fusion? World J Orthop 2013;4:112–3.
    1. Kong L, Cao J, Wang L, et al. Prevalence of adjacent segment disease following cervical spine surgery: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore) 2016;95:e4171.
    1. Eck JC, Humphreys SC, Lim TH, et al. Biomechanical study on the effect of cervical spine fusion on adjacent-level intradiscal pressure and segmental motion. Spine 2002;27:2431–4.
    1. Park DH, Ramakrishnan P, Cho TH, et al. Effect of lower two-level anterior cervical fusion on the superior adjacent level. J Neurosurg Spine 2007;7:336–40.
    1. van Eck CF, Regan C, Donaldson WF, et al. The revision rate and occurrence of adjacent segment disease after anterior cervical discectomy and fusion: a study of 672 consecutive patients. Spine 2014;39:2143–7.
    1. Chung JY, Kim SK, Jung ST, et al. Clinical adjacent-segment pathology after anterior cervical discectomy and fusion: results after a minimum of 10-year follow-up. Spine J 2014;14:2290–8.
    1. Janssen ME, Zigler JE, Spivak JM, et al. ProDisc-C total disc replacement versus anterior cervical discectomy and fusion for single-level symptomatic cervical disc disease: seven-year follow-up of the prospective randomized U.S. Food and Drug Administration Investigational Device Exemption Study. J Bone Joint Surg Am 2015;97:1738–47.
    1. Radcliff K, Coric D, Albert T. 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. J Neurosurg Spine 2016;25:213–24.
    1. Duggal N, Pickett GE, Mitsis DK, et al. Early clinical and biomechanical results following cervical arthroplasty. Neurosurg Focus 2004;17:E9.
    1. Bryan VE., Jr Cervical motion segment replacement. Eur Spine J 2002;11(suppl 2):S92–7.
    1. Coric D, Nunley PD, Guyer RD, et al. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine 2011;15:348–58.
    1. Lei T, Liu Y, Wang H, et al. Clinical and radiological analysis of Bryan cervical disc arthroplasty: eight-year follow-up results compared with anterior cervical discectomy and fusion. Int Orthop 2016;40:1197–203.
    1. Phillips FM, Geisler FH, Gilder KM, et al. Long-term outcomes of the US FDA IDE prospective, randomized controlled clinical trial comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. Spine 2015;40:674–83.
    1. Zhang J, Meng F, Ding Y, et al. Hybrid surgery versus anterior cervical discectomy and fusion in multilevel cervical disc diseases: a meta-analysis. Medicine (Baltimore) 2016;95:e3621.
    1. Yin S, Yu X, Zhou S, et al. Is cervical disc arthroplasty superior to fusion for treatment of symptomatic cervical disc disease? A meta-analysis. Clin Orthop Relat Res 2013;471:1904–19.
    1. Yang B, Li H, Zhang T, et al. The incidence of adjacent segment degeneration after cervical disc arthroplasty (CDA): a meta analysis of randomized controlled trials. PLoS One 2012;7:e35032.
    1. Burkus JK, Traynelis VC, Haid RW, Jr, et al. Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: clinical article. J Neurosurg Spine 2014;21:516–28.
    1. Zigler JE, Delamarter R, Murrey D, et al. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine 2013;38:203–9.
    1. Jackson RJ, Davis RJ, Hoffman GA, et al. Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. J Neurosurg Spine 2016;24:734–45.
    1. Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ 2015;349:g7647.
    1. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol 2009;62:e1–34.
    1. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009;6:e1000097.
    1. Huedo-Medina TB, Sanchez-Meca J, Marin-Martinez F, et al. Assessing heterogeneity in meta-analysis: Q statistic or I2 index? Psychol Methods 2006;11:193–206.
    1. Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–34.
    1. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994;50:1088–101.

Source: PubMed

3
Předplatit