Evidence-based use of arthroplasty in cervical degenerative disc disease
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Cervical disc arthroplasty (CDA) was developed to decrease the rate of symptomatic adjacent-level disease while preserving motion in the cervical spine.
The objectives of this paper are to provide criteria for proper patient selection as well as to present a comprehensive literature review of the current evidence for CDA, including randomized studies, the most recent meta-analysis findings, and long-term follow-up clinical trials as well.
Currently, there are several prospective randomized controlled studies of level I of evidence attesting to the safety and efficacy of CDA in the management of cervical spondylotic disease (CSD) for one- or two-level degenerative diseases. These as well as recent meta-analyses suggest that CDA is potentially similar or even superior to anterior cervical discectomy and fusion (ACDF) when considering several outcomes, including dysphagia and re-operation rate over medium-term follow-up. Less robust studies have also reported satisfactory clinical and radiological outcomes of CDA for hybrid procedures (ACDF combined with CDA), non-contiguous disease, and even for multilevel disease (more than 2 levels).
Based on this evidence we conclude that CDA is a safe and effective alternative to ACDF in properly selected patients for one- or two-level diseases. Defining superiority of specific implants and detailing optimal surgical indications will require further well-designed long-term studies.
KeywordsSpondylotic cervical disease Cervical arthroplasty Anterior cervical approaches Anterior surgery Discectomy Arthroplasty
- 5.Nunley PD, Coric D, Frank KA, Stone MB (2018) Cervical disc arthroplasty: current evidence and real-world application. NeurosurgeryGoogle Scholar
- 7.Murrey D, Janssen M, Delamarter R et al (2009) Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. Spine J 9(4):275–286CrossRefGoogle Scholar
- 10.Delamarter RB, Murrey D, Janssen ME et al (2010) Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients. SAS J 4(4):122–128CrossRefGoogle Scholar
- 11.Coric D, Nunley PD, Guyer RD et al (2011) 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 15(4):348–358CrossRefGoogle Scholar
- 13.Phillips FM, Lee JY, Geisler FH et al (2013) A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. 2-year results from the US FDA IDE clinical trial. Spine (Phila Pa 1976) 38(15):E907–E918CrossRefGoogle Scholar
- 14.Vaccaro A, Beutler W, Peppelman W et al (2013) Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty: two-year results from a prospective, randomized, controlled, multicenter investigational device exemption study. Spine (Phila Pa 1976) 38(26):2227–2239CrossRefGoogle Scholar
- 17.Hisey MS, Bae HW, Davis R, et al (2014) Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine. Int J Spine Surg 8Google Scholar
- 24.Janssen ME, Zigler JE, Spivak JM, Delamarter RB, Darden BV 2nd, Kopjar B (2015) 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 97(21):1738–1747CrossRefGoogle Scholar
- 25.Ghobrial GM, Lavelle WF, Florman JE, Riew KD, Levi AD (2018) Symptomatic adjacent level disease requiring surgery: analysis of 10-year results from a prospective, randomized, clinical trial comparing cervical disc arthroplasty to anterior cervical fusion. NeurosurgeryGoogle Scholar
- 26.Davis RJ, Kim KD, Hisey MS et al (2013) Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine 19(5):532–545CrossRefGoogle Scholar
- 29.Radcliff K, Coric D, Albert T (2016) 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 25(2):213–224CrossRefGoogle Scholar
- 30.Gornet MF, Lanman TH, Burkus JK et al (2017) Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months. J Neurosurg Spine 26(6):653–667CrossRefGoogle Scholar
- 31.Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD (2017) Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine 27(1):7–19CrossRefGoogle Scholar
- 32.Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD (2017) Long term clinical and radiographic outcomes of the Prestige LP artificial cervical discreplacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine 27(1):7–19CrossRefGoogle Scholar
- 39.Zhao H, Duan LJ, Gao YS, Yang YD, Tang XS, Zhao DY, Xiong Y, Hu ZG, Li CH, Yu X (2018) What is the superior surgical strategy for bi-level cervical spondylosis-anterior cervical disc replacement or anterior cervical decompression and fusion?: a meta-analysis from 11 studies. Medicine (Baltimore) 97(13):e0005CrossRefGoogle Scholar
- 44.Alvin MD, Mroz TE (2014) The Mobi-C cervical disc for one-level and two-level cervical disc replacement: a review of the literature. Med Devices (Auckl) 7:397–403Google Scholar
- 46.Blumenthal SL, Ohnmeiss DD, Guyer RD, Zigler JE (2013) Reoperations in cervical total disc replacement compared with anterior cervical fusion: results compiled from multiple prospective food and drug administration investigational device exemption trials conducted at a single site. Spine (Phila Pa 1976) 38(14):1177–1182CrossRefGoogle Scholar
- 47.Jackson RJ, Davis RJ, Hoffman GA et al (2016) 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 24(5):734–745CrossRefGoogle Scholar
- 51.Fernström U (1966) Arthroplasty with intercorporal endoprothesis in herniated disc and in painful disc. Acta Chir Scand Suppl 357:154–159Google Scholar
- 53.Zeng J, Liu H, Chen H, et al. Effect of prosthesis width and depth on heterotopic ossification after cervical disc arthroplasty. Spine (Phila Pa 1976). 2018Google Scholar
- 54.Zeng J, Liu H, Chen H et al (2018) Comparison of heterotopic ossification after fixed- and mobile-core cervical disc arthroplasty. World Neurosurg S1878-8750(18):32121–32121Google Scholar