Mid- to Long-Term Outcomes of Cervical Disc Arthroplasty versus Anterior Cervical Discectomy and Fusion for Treatment of Symptomatic Cervical Disc Disease: A Systematic Review and Meta-Analysis of Eight Prospective Randomized Controlled Trials

Yan Hu, Guohua Lv, Siying Ren, Daniel Johansen, Yan Hu, Guohua Lv, Siying Ren, Daniel Johansen

Abstract

Purpose: This study aimed to investigate the mid- to long-term outcomes of cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) for the treatment of 1-level or 2-level symptomatic cervical disc disease.

Methods: Medline, Embase, and the Cochrane Central Register of Controlled Trials databases were searched to identify relevant randomized controlled trials that reported mid- to long-term outcomes (at least 48 months) of CDA versus ACDF. All data were analyzed by Review Manager 5.3 software. The relative risk (RR) and 95% confidence intervals (CIs) were calculated for dichotomous variables. The weighted mean difference (WMD) and 95%CIs were calculated for continuous variables. A random effect model was used for heterogeneous data; otherwise, a fixed effect model was used.

Results: Eight prospective randomized controlled trials (RCTs) were retrieved in this meta-analysis, including 1317 and 1051 patients in CDA and ACDF groups, respectively. Patients after an ACDF had a significantly lower rate of follow-up than that after CDA. Pooled analysis showed patients in CDA group achieved significantly higher rates of overall success, Neck Disability Index (NDI) success, neurological success and significantly lower rates of implant/surgery-related serious adverse events and secondary procedure compared with that in ACDF group. The long-term functional outcomes (NDI, Visual Analog Scale (VAS) neck and arm pain scores, the Short Form 36 Health Survey physical component score (SF-36 PCS)), patient satisfaction and recommendation, and the incidence of superior adjacent segment degeneration also favored patients in CDA group with statistical difference. Regarding inferior adjacent segment degeneration, patients in CDA group had a lower rate without statistical significance.

Conclusions: This meta-analysis showed that cervical disc arthroplasty was superior over anterior discectomy and fusion for the treatment of symptomatic cervical disc disease in terms of overall success, NDI success, neurological success, implant/surgery-related serious adverse events, secondary procedure, functional outcomes, patient satisfaction and recommendation, and superior adjacent segment degeneration.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flow chart showing search strategy.
Fig 1. Flow chart showing search strategy.
Fig 2. Forest plot for overall success…
Fig 2. Forest plot for overall success and NDI success.
Fig 3. Forest plot for neurological success…
Fig 3. Forest plot for neurological success and implant/surgery-related serious adverse events.
Fig 4. Forest plot for secondary procedure.
Fig 4. Forest plot for secondary procedure.
Fig 5. Forest plot for functional outcomes.
Fig 5. Forest plot for functional outcomes.
Fig 6. Forest plot for patient satisfaction…
Fig 6. Forest plot for patient satisfaction and recommendation.
Fig 7. Forest plot for radiological adjacent…
Fig 7. Forest plot for radiological adjacent segment degeneration.
Fig 8. Forest plot for follow-up rate.
Fig 8. Forest plot for follow-up rate.

References

    1. Buchowski JM, Anderson PA, Sekhon L, Riew KD. Cervical disc arthroplasty compared with arthrodesis for the treatment of myelopathy. Surgical technique. J Bone Joint Surg Am. 2009; 91 Suppl 2:223–32. 10.2106/JBJS.I.00564
    1. Rao RD, Currier BL, Albert TJ, Bono CM, Marawar SV, Poelstra KA, et al. Degenerative cervical spondylosis: clinical syndromes, pathogenesis, and management. J Bone Joint Surg Am. 2007; 89(6): 1360–78.
    1. Bohlman HH, Emery SE, Goodfellow DB, Jones PK. Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am. 1993; 75(9): 1298–307.
    1. Hilibrand AS, Carlson GD, Palumbo MA, Jones PK, Bohlman HH. Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am. 1999; 81(4): 519–28.
    1. Majd ME, Vadhva M, Holt RT. Anterior cervical reconstruction using titanium cages with anterior plating. Spine (Phila Pa 1976). 1999; 24(15): 1604–10.
    1. Yue WM, Brodner W, Highland TR. Long-term results after anterior cervical discectomy and fusion with allograft and plating: a 5- to 11- year radiologic and clinical follow-up study. Spine (Phila Pa 1976). 2005; 30(19): 2138–44.
    1. Goffin J, Geusens E, Vantomme N, Quintens E, Waerzeggers Y, Depreitere B, et al. Long-term follow-up after interbody fusion of the cervical spine. J Spinal Disord Tech. 2004; 17(2): 79–85.
    1. Shriver MF, Lewis DJ, Kshettry VR, Rosenbaum BP, Benzel EC, Mroz TE. Pseudoarthrosis rates in anterior cervical discectomy and fusion: a meta-analysis. Spine J. 2015; 15(9): 2016–27. 10.1016/j.spinee.2015.05.010
    1. Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J. 2004; 4(6 Suppl): 190S–194S.
    1. Wigfield C, Gill S, Nelson R, Langdon I, Metcalf N, Robertson J. Influence of an artificial cervical joint compared with fusion on adjacent-level motion in the treatment of degenerative cervical disc disease. J Neurosurg. 2002; 96(1 Suppl): 17–21.
    1. Hilibrand AS, Carlson GD, Palumbo MA, Jones PK, Bohlman HH. Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am. 1999; 81(4): 519–28.
    1. DiAngelo DJ, Roberston JT, Metcalf NH, McVay BJ, Davis RC. Biomechanical testing of an artificial cervical joint and an anterior cervical plate. J Spinal Disord Tech. 2003; 16(4): 314–23.
    1. Dmitriev AE, Cunningham BW, Hu N, Sell G, Vigna F, McAfee PC. Adjacent level intradiscal pressure and segmental kinematics following a cervical total disc arthroplasty: an in vitro human cadaveric model. Spine (Phila Pa 1976). 2005; 30(10): 1165–72.
    1. Gandhi AA, Kode S, DeVries NA, Grosland NM, Smucker JD, Fredericks DC. Biomechanical Analysis of Cervical Disc Replacement and Fusion Using Single Level, Two level and Hybrid Constructs. Spine (Phila Pa 1976). 2015. 40(10): 1578–1585.
    1. Lee JH, Kim JS, Lee JH, Chung ER, Shim CS, Lee SH. Comparison of cervical kinematics between patients with cervical artificial disc replacement and anterior cervical discectomy and fusion for cervical disc herniation. Spine J. 2014; 14(7): 1199–204. 10.1016/j.spinee.2013.08.010
    1. Anakwenze OA, Auerbach JD, Milby AH, Lonner BS, Balderston RA. Sagittal cervical alignment after cervical disc arthroplasty and anterior cervical discectomy and fusion: results of a prospective, randomized, controlled trial. Spine (Phila Pa 1976). 2009; 34(19): 2001–7. 10.1097/BRS.0b013e3181b03fe6
    1. Chen J, Wang X, Bai W, Shen X, Yuan W. Prevalence of heterotopic ossification after cervical total disc arthroplasty: a meta-analysis. Eur Spine J. 2012; 21(4): 674–80. 10.1007/s00586-011-2094-x
    1. Leung C, Casey AT, Goffin J, Kehr P, Liebig K, Lind B, et al. Clinical significance of heterotopic ossification in cervical disc replacement: a prospective multicenter clinical trial. Neurosurgery. 2005; 57(4): 759–63.
    1. Zechmeister I, Winkler R, Mad P. Artificial total disc replacement versus fusion for the cervical spine: a systematic review. Eur Spine J. 2011; 20(2): 177–84. 10.1007/s00586-010-1583-7
    1. Ganbat D, Kim K, Jin YJ, Kim YH. Heterotopic ossification in cervical total disk replacement: a finite element analysis. Proc Inst Mech Eng H. 2014; 228(2): 200–5. 10.1177/0954411914522024
    1. Pickett GE, Sekhon LH, Sears WR, Duggal N. Complications with cervical arthroplasty. J Neurosurg Spine. 2006; 4(2): 98–105.
    1. Wagner SC, Kang DG, Helgeson MD. Implant migration after Bryan cervical disc arthroplasty. Spine J. 2014; 14(10): 2513–4. 10.1016/j.spinee.2014.05.005
    1. Tsermoulas G, Bhattathiri PS. Anterior migration of prosthesis following cervical arthroplasty. Br J Neurosurg. 2013; 27(1): 132–3. 10.3109/02688697.2012.703354
    1. Hacker FM, Babcock RM, Hacker RJ. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site. Spine (Phila Pa 1976). 2013; 38(26): 2223–6. 10.1097/BRS.0000000000000060
    1. Cheng L, Nie L, Li M, Huo Y, Pan X. Superiority of the Bryan(®) disc prosthesis for cervical myelopathy: a randomized study with 3-year follow-up. Clin Orthop Relat Res. 2011; 469(12): 3408–14. 10.1007/s11999-011-2039-z
    1. Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick TA. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007; 6(3): 198–209.
    1. Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, 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(4): 348–58. 10.3171/2011.5.SPINE10769
    1. Park DK, Lin EL, Phillips FM. Index and adjacent level kinematics after cervical disc replacement and anterior fusion: in vivo quantitative radiographic analysis. Spine (Phila Pa 1976). 2011; 36(9): 721–30. 10.1097/BRS.0b013e3181df10fc
    1. Delamarter RB, Zigler J. Five-year reoperation rates, cervical total disc replacement versus fusion, results of a prospective randomized clinical trial. Spine (Phila Pa 1976). 2013; 38(9): 711–7. 10.1097/BRS.0b013e3182797592
    1. Phillips FM, Lee JY, Geisler FH, Cappuccino A, Chaput CD, DeVine JG, et al. 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). 2013; 38(15): E907–18. 10.1097/BRS.0b013e318296232f
    1. Hisey MS, Bae HW, Davis R, Gaede S, Hoffman G, Kim K, et al. 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. 2014; 8 10.14444/1007
    1. Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, et al. 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. 2013; 19(5): 532–45. 10.3171/2013.6.SPINE12527
    1. Luo J, Gong M, Huang S, Yu T, Zou X. Incidence of adjacent segment degeneration in cervical disc arthroplasty versus anterior cervical decompression and fusion meta-analysis of prospective studies. Arch Orthop Trauma Surg. 2015; 135(2): 155–60. 10.1007/s00402-014-2125-2
    1. Gao Y, Liu M, Li T, Huang F, Tang T, Xiang Z. A meta-analysis comparing the results of cervical disc arthroplasty with anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical disc disease. J Bone Joint Surg Am. 2013; 95(6): 555–61. 10.2106/JBJS.K.00599
    1. Nabhan A, Steudel WI, Nabhan A, Pape D, Ishak B. Segmental kinematics and adjacent level degeneration following disc replacement versus fusion: RCT with three years of follow-up. J Long Term Eff Med Implants. 2007; 17(3): 229–36.
    1. Maldonado CV, Paz RD, Martin CB. Adjacent-level degeneration after cervical disc arthroplasty versus fusion. Eur Spine J. 2011; 20 Suppl 3:403–7. 10.1007/s00586-011-1916-1
    1. Karabag H, Cakmak E, Celik B, Iplikcioglu AC, Soran AF. Arthroplasty versus fusion for single-level cervical disc disease. J Pak Med Assoc. 2014; 64(12): 1348–51.
    1. Jawahar A, Cavanaugh DA, Kerr EJ 3rd, Birdsong EM, Nunley PD. Total disc arthroplasty does not affect the incidence of adjacent segment degeneration in cervical spine: results of 93 patients in three prospective randomized clinical trials. Spine J. 2010; 10(12): 1043–8. 10.1016/j.spinee.2010.08.014
    1. Nabhan A, Ishak B, Steudel WI, Ramadhan S, Steimer O. Assessment of adjacent-segment mobility after cervical disc replacement versus fusion: RCT with 1 year’s results. Eur Spine J. 2011; 20(6): 934–41. 10.1007/s00586-010-1588-2
    1. Verma K, Gandhi SD, Maltenfort M, Albert TJ, Hilibrand AS, Vaccaro AR, et al. Rate of adjacent segment disease in cervical disc arthroplasty versus single-level fusion: meta-analysis of prospective studies. Spine (Phila Pa 1976). 2013; 38(26): 2253–7. 10.1097/BRS.0000000000000052
    1. Yang B, Li H, Zhang T, He X, Xu S. The incidence of adjacent segment degeneration after cervical disc arthroplasty (CDA): a meta analysis of randomized controlled trials. PLos One. 2012; 7(4): e35032 10.1371/journal.pone.0035032
    1. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Loannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analysis of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009; 6(7): e1000100 10.1371/journal.pmed.1000100
    1. Tian W, Yan K, Han X, Yu J, Jin P, Han X. Comparison of the Clinical and Radiographic Results between Cervical Artificial Disc Replacement and Anterior Cervical Fusion: A Six-year Prospective Non-randomized Comparative Study. J Spinal Disord Tech. 2014. 10.1097/BSD.0000000000000206
    1. Bartels RH, Donk R, van der Wilt GJ, Grotenhuis JA, Venderink D. Design of the PROCON trial: a prospective, randomized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty. BMC Musculoskelet Disord. 2006; 7:85
    1. Bae HW, Kim KD, Nunley PD, Jackson RJ, Hisey MS, Davis RJ, et al. Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement: Four-Year Results From a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial. Spine (Phila Pa 1976). 2015; 40(11): 759–66. 10.1097/BRS.0000000000000887
    1. Arts MP, Brand R, van den Akker E, Koes BW, Peul WC. The NEtherlands Cervical Kinematics (NECK) trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomized multicenter study. BMC Musculoskelet Disord. 2010; 11:122 10.1186/1471-2474-11-122
    1. Ament JD, Yang Z, Chen Y, Green RS, Kim KD. A Novel Quality-of-Life Utility Index in Patients With Multilevel Cervical Degenerative Disc Disease: Comparison of Anterior Cervical Discectomy and Fusion With Total Disc Replacement. Spine (Phila Pa 1976). 2015; 40(14): 1072–8. 10.1097/BRS.0000000000000898
    1. Peng-Fei S, Yu-Hua J. Cervical disc prosthesis replacement and interbody fusion: a comparative study. Int Orthop. 2008; 32(1):103–6.
    1. Nunley PD, Jawahar A, Cavanaugh DA, Gordon CR, Kerr EJ 3rd, Utter PA. Symptomatic adjacent segment disease after cervical total disc replacement: re-examining the clinical and radiological evidence with established criteria. Spine J. 2013; 13(1): 5–12. 10.1016/j.spineee.2012.11.032
    1. Burkus JK, Haid RW, Traynelis VC, Mummaneni PV. Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled trial. J Neurosurg Spine. 2010; 13(3): 308–18. 10.3171/2010.3.SPINE09513
    1. Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M. 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 (Phila Pa 1976). 2013; 38(3): 203–9. 10.1097/BRS.0b013e318278eb38
    1. Garrido BJ, Taha TA, Sasso RC. Clinical outcomes of Bryan cervical disc arthroplasty a prospective, randomized, controlled, single site trial with 48-month follow-up. J Spinal Disord Tech. 2010; 23(6): 367–71. 10.1097/BSD.0b013e3181bb8568
    1. Burkus JK, Traynelis VC, Haid RW Jr, Mummaneni PV. 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(4): 516–28. 10.3171/2014.6.SPINE13996
    1. Coric D, Kim PK, Clemente JD, Boltes MO, Nussbaum M, James S. Prospective randomized study of cervical arthroplasty and anterior cervical discectomy and fusion with long-term follow-up: results in 74 patients from a single site. J Neurosurg Spine. 2013; 18(1): 36–42. 10.3171/2012.9.SPINE12555
    1. Davis RJ, Nunley PD, Kim KD, Hisey MS, Jackson RJ, Bae HW, et al. Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. J Neurosurg Spine. 2015; 22(1): 15–25. 10.3171/2014.7.SPINE13953
    1. Hisey MS, Bae HW, Davis RJ, Gaede S, Hoffman G, Kim KD, et al. Prospective, Randomized Comparison of Cervical Total Disk Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up. J Spinal Disord Tech. 2015; 28(4): E237–43. 10.1097/BSD.0000000000000185
    1. Phillips FM, Geisler FH, Gilder KM, Reah C, Howell KM, McAfee PC. 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 (Phila Pa 1976). 2015; 40(10): 674–83. 10.1097/BRS.0000000000000869
    1. Sasso RC, Anderson PA, Riew KD, Heller JG. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. 2011; 93(18): 1684–92. 10.2106/JBJS.J.00476
    1. Zhang HX, Shao YD, Chen Y, Hou Y, Cheng L, Si M, et al. A prospective, randomised, controlled multicentre study comparing cervical disc replacement with anterior cervical decompression and fusion. Int Orthop. 2014; 38(12): 2533–41. 10.1007/s00264-014-2497-5
    1. Janssen ME, Zigler JE, Spivak JM, Delamarter RB, Darden BV 2nd, Kopjar B. 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(21): 1738–47. 10.2106/JBJS.N.01186
    1. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957; 16(4): 494–502.
    1. Walraevens J, Demaerel P, Suetens P, Van Calenbergh F, van Loon J, Vander Sloten J, et al. Longitudinal prospective long-term radiographic follow-up after treatment of single-level cervical disk disease with the Bryan Cervical Disc. Neurosurgery. 2010; 67(3): 679–87; discussion 687. 10.1227/01.NEU.0000377039.89725.F3
    1. Wu AM, Xu H, Mullinix KP, Jin HM, Huang ZY, Lv QB, et al. Minimum 4-year outcomes of cervical total disc arthroplasty versus fusion: a meta-analysis based on prospective randomized controlled trials. Medicine (Baltimore). 2015; 94(15): e665 10.1097/MD.0000000000000665
    1. Ren C, Song Y, Xue Y, Yang X. Mid- to long-term outcomes after cervical disc arthroplasty compared with anterior discectomy and fusion: a systematic review and meta-analysis of randomized controlled trials. Eur Spine J. 2014; 23(5): 1115–23. 10.1007/s00586-014-3220-3
    1. Shriver MF, Lubelski D, Sharma AM, Steinmetz MP, Benzel EC, Mroz TE. Adjacent segment degeneration and disease following cervical arthroplasty: a systematic review and meta-analysis. Spine J. pii: S1529-9430(15)01544-2. 10.1016/j.spinee.2015.10.032

Source: PubMed

3
Subscribe