Research protocol: Cervical Arthroplasty Cost Effectiveness Study (CACES): economic evaluation of anterior cervical discectomy with arthroplasty (ACDA) versus anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical degenerative disc disease - a randomized controlled trial

Valérie N E Schuermans, Anouk Y J M Smeets, Toon F M Boselie, Math J J M Candel, Inez Curfs, Silvia M A A Evers, Henk Van Santbrink, Valérie N E Schuermans, Anouk Y J M Smeets, Toon F M Boselie, Math J J M Candel, Inez Curfs, Silvia M A A Evers, Henk Van Santbrink

Abstract

Introduction: To date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history, and progression of disease play a role in the development of CASP remains unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long term.

Methods and analysis: In this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months until 4 years post-surgery.

Discussion: High-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question.

Trial registration: ClinicalTrials.gov NCT04623593. Registered on 29 September 2020.

Keywords: Anterior cervical discectomy and fusion; Anterior cervical discectomy with arthroplasty; Cervical degenerative disc disease; Cervical myelopathy; Cervical radiculopathy; Cost-effectiveness.

Conflict of interest statement

The authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study design. Timing of pre- and post-operative outcome measurements and follow-up evaluations

References

    1. Abdulkarim JA, Dhingsa R, Finlay DBL. Magnetic resonance imaging of the cervical spine: frequency of degenerative changes in the intervertebral disc with relation to age. Clin Radiol. 2003;58(12):980–984. doi: 10.1016/S0009-9260(03)00255-1.
    1. European Commission - Eurostat . Ageing Europe - looking at the lives of older people in the EU. European Union. 2019.
    1. Woods BI, Hilibrand AS. Cervical radiculopathy: epidemiology, etiology, diagnosis, and treatment. J Spinal Disord Techn. 2015;28(5):E251–E259. doi: 10.1097/BSD.0000000000000284.
    1. Neifert SN, Martini ML, Yuk F, McNeill IT, Caridi JM, Steinberger J, et al. Predicting trends in cervical spinal surgery in the United States from 2020 to 2040. WORLD Neurosurg. 2020;141:E175–E181. doi: 10.1016/j.wneu.2020.05.055.
    1. Hammer C, Heller J, Kepler C. Epidemiology and pathophysiology of cervical disc herniation. Semin Spine Surg. 2016.
    1. Roughley P, Martens D, Rantakokko J, Alini M, Mwale F, Antoniou J. The involvement of aggrecan polymorphism in degeneration of human intervertebral disc and articular cartilage. Eur Cells Materials. 2006;11:1–7. doi: 10.22203/eCM.v011a01.
    1. Jacobs WCH, Anderson PG, Limbeek J, Willems PC, Pavlov P. Single or double-level anterior interbody fusion techniques for cervical degenerative disc disease. Cochrane Database Syst Rev. 2004;(4):CD004958.
    1. Korinth MC. Treatment of cervical degenerative disc disease - current status and trends. Zentralbl Neurochir. 2008;69(3):113–124. doi: 10.1055/s-2008-1081201.
    1. Dowd GC, Wirth FP. Anterior cervical discectomy: is fusion necessary? J Neurosurg. 1999;90(1 Suppl):8–12.
    1. Schuermans V, Smeets AYJM, Wijsen NPMH, Curfs I, Boselie TFM, van Santbrink H. Clinical adjacent segment pathology after anterior cervical decompression surgery for cervical degenerative disc disease: a single center retrospective cohort study with long-term follow-up. Brain Spine. 2022;2:100869.
    1. Fehlings MG, Ibrahim A, Tetreault L, Albanese V, Alvarado M, Arnold P, et al. A global perspective on the outcomes of surgical decompression in patients with cervical spondylotic myelopathy: results from the prospective multicenter AOSpine international study on 479 patients. Spine (Phila Pa 1976) 2015;40(17):1322–1328. doi: 10.1097/BRS.0000000000000988.
    1. Xie J, Hurlbert RJ. Discectomy versus discectomy with fusion versus discectomy with fusion and instrumentation: a prospective randomized study. Neurosurgery. 2007;61(1):107–116. doi: 10.1227/01.neu.0000279730.44016.da.
    1. Joo Y-H, Lee J-W, Kwon K-Y, Rhee J-J, Lee H-K. Comparison of fusion with cage alone and plate instrumentation in two-level cervical degenerative disease. J KOREAN Neurosurg Soc. 2010;48(4):342–346. doi: 10.3340/jkns.2010.48.4.342.
    1. Donk RD, Verbeek ALM, Verhagen WIM, Groenewoud H, Hosman AJF, Bartels RHMA. What’s the best surgical treatment for patients with cervical radiculopathy due to single-level degenerative disease? A randomized controlled trial. PLoS One. 2017;12(8):e0183603. doi: 10.1371/journal.pone.0183603.
    1. Nandoe Tewarie RDS, Bartels RHMA, Peul WC. Long-term outcome after anterior cervical discectomy without fusion. Eur spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc. 2007;16(9):1411–1416. doi: 10.1007/s00586-007-0309-y.
    1. Riew KD, Norvell DC, Chapman JR, Skelly AC, Dettori JR. Introduction/summary statement: adjacent segment pathology. Spine. 2012;37(22 Suppl):S1–S7. doi: 10.1097/BRS.0b013e31826cef01.
    1. Lawrence BD, Hilibrand AS, Brodt ED, Dettori JR, Brodke DS. Predicting the risk of adjacent segment pathology in the cervical spine: a systematic review. Spine. 2012;37(22 Suppl):S52–S64. doi: 10.1097/BRS.0b013e31826d60fb.
    1. Gornet MF, Lanman TH, Burkus JK, Dryer RF, McConnell JR, Hodges SD, et al. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. 2019:1–11. [Internet]. Available from: .
    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. 2016;16(2):168–181. doi: 10.1016/j.spinee.2015.10.032.
    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 Jt Surg - Ser A. 1999;81(4):519–528. doi: 10.2106/00004623-199904000-00009.
    1. Robertson JT, Papadopoulos SM, Traynelis VC. Assessment of adjacent-segment disease in patients treated with cervical fusion or arthroplasty: a prospective 2-year study. J Neurosurg Spine. 2005;3(6):417–423. doi: 10.3171/spi.2005.3.6.0417.
    1. Gore DR, Sepic SB. Anterior cervical fusion for degenerated or protruded discs. A review of one hundred forty-six patients. Spine (Phila Pa 1976) 1984;9(7):667–671. doi: 10.1097/00007632-198410000-00002.
    1. Williams JL, Allen MBJ, Harkess JW. Late results of cervical discectomy and interbody fusion: some factors influencing the results. J Bone Joint Surg Am. 1968;50(2):277–286. doi: 10.2106/00004623-196850020-00006.
    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 Jt Surg Am. 1993;75(9):1298–1307. doi: 10.2106/00004623-199309000-00005.
    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. doi: 10.1016/j.spinee.2004.07.007.
    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):519–528. doi: 10.2106/00004623-199904000-00009.
    1. Gore DR, Sepic SB. Anterior discectomy and fusion for painful cervical disc disease. A report of 50 patients with an average follow-up of 21 years. Spine (Phila Pa 1976) 1998;23(19):2047–2051. doi: 10.1097/00007632-199810010-00002.
    1. Helgeson MD, Bevevino AJ, Hilibrand AS. Update on the evidence for adjacent segment degeneration and disease. Spine J. 2013;13(3):342–351. doi: 10.1016/j.spinee.2012.12.009.
    1. Seo M, Choi D. Adjacent segment disease after fusion for cervical spondylosis; myth or reality? Br J Neurosurg. 2008;22(2):195–199. doi: 10.1080/02688690701790605.
    1. Eck JC, Humphreys SC, Lim T-H, Jeong ST, Kim JG, Hodges SD, et al. Biomechanical study on the effect of cervical spine fusion on adjacent-level intradiscal pressure and segmental motion. Spine (Phila Pa 1976) 2002;27(22):2431–2434. doi: 10.1097/00007632-200211150-00003.
    1. Martins AN. Anterior cervical discectomy with and without interbody bone graft. J Neurosurg. 1976;44(3):290–295. doi: 10.3171/jns.1976.44.3.0290.
    1. Hauerberg J, Kosteljanetz M, Bøge-Rasmussen T, Dons K, Gideon P, Springborg JB, et al. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study. Spine (Phila Pa 1976) 2008;33(5):458–464. doi: 10.1097/BRS.0b013e3181657dac.
    1. Ji GY, Oh CH, Shin DA, Ha Y, Kim KN, Yoon DH, et al. Stand-alone cervical cages versus anterior cervical plates in 2-level cervical anterior interbody fusion patients: analysis of adjacent segment degeneration. J Spinal Disord Tech. 2015;28(7):E433–E438. doi: 10.1097/BSD.0b013e3182a355ad.
    1. Boselie TFM, van Mameren H, de Bie RA, van Santbrink H. Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT. BMC Musculoskelet Disord. 2015;16:34. doi: 10.1186/s12891-015-0479-4.
    1. Boselie TFM, Willems PC, van Mameren H, de Bie RA, Benzel EC, van Santbrink H. Arthroplasty versus fusion in single-level cervical degenerative disc disease: a Cochrane review. Spine (Phila Pa 1976) 2013;38(17):E1096–E1107. doi: 10.1097/BRS.0b013e3182994a32.
    1. Vleggeert-Lankamp CLA, Janssen TMH, van Zwet E, Goedmakers CMW, Bosscher L, Peul W, et al. The NECK trial: effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blinded randomized controlled trial. Spine J. 2019;19(6):965–975. doi: 10.1016/j.spinee.2018.12.013.
    1. Zhang Y, Liang C, Tao Y, Zhou X, Li H, Li F, et al. Cervical total disc replacement is superior to anterior cervical decompression and fusion: a meta-analysis of prospective randomized controlled trials. PLoS One. 2015;10(3):e0117826. doi: 10.1371/journal.pone.0117826.
    1. Maharaj MM, Mobbs RJ, Hogan J, Zhao DF, Rao PJ, Phan K. Anterior cervical disc arthroplasty (ACDA) versus anterior cervical discectomy and fusion (ACDF): a systematic review and meta-analysis. J Spine Surg (Hong Kong) 2015;1(1):72–85.
    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. J Neurosurg Spine. 2016;25(2):213–24.
    1. Kong L, Cao J, Wang L, Shen Y. Prevalence of adjacent segment disease following cervical spine surgery. Medicine (United States). 2016.
    1. Schuermans V, Smeets AYJM, Boselie TFM, Zarrouk O, Hermans SMM, Droeghaag R, et al. Cost-effectiveness of anterior surgical decompression surgery for cervical degenerative disc disease: a systematic review of economic evaluations. Eur Spine J. 2022;31(5):1206–18.
    1. Radcliff K, Davis RJ, Hisey MS, Nunley PD, Hoffman GA, Jackson RJ, et al. Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J spine Surg. 2017;11(4):31.
    1. Jackson RJ, Davis RJ, Bae HW, Hoffman GA, Hisey MS, Kim KD, et al. Subsequent surgery rates after treatment with TDR or ACDF at one or two levels: results from an FDA clinical trial at 7 years. Spine J [Internet]. 2016;16(10 CC-Back and Neck):S204-S205. Available from: .
    1. Ramch, ran S, Smith JS, Ailon T, Klineberg E, Shaffrey C, et al. Assessment of Impact of Long-Cassette Standing X-Rays on Surgical Planning for Cervical Pathology: An International Survey of Spine Surgeons. Neurosurgery. 2016;78(5):717–24.
    1. Ramch, ran S, Smith JS, Ailon T, Klineberg E, Shaffrey C, et al. Assessment of Impact of Long-Cassette Standing X-Rays on Surgical Planning for Cervical Pathology: An International Survey of Spine Surgeons. Neurosurgery. 2016;78(5):717–24.
    1. Loumeau TP, Darden BV, Kesman TJ, Odum SM, Van Doren BA, Laxer EB, et al. A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF) Eur spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc. 2016;25(7):2263–2270. doi: 10.1007/s00586-016-4431-6.
    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 Stud. J Bone Joint Surg Am. 2015;97(21):1738–47.
    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.
    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) [Internet]. 2013;38(9 CC-Back and Neck):711-7. Available from: .
    1. Murrey D, Janssen M, Delamarter R, Goldstein J, Zigler J, Tay B, et al. 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 cerv. Spine J. 2009;9(4):275–86.
    1. Gornet MF, Burkus JK, Shaffrey ME, Schranck FW, Copay AG. Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level. J Neurosurg Spine. 2019;31(3):317–25.
    1. Gornet MF, Lanman TH, Kenneth Burkus J, Hodges SD, McConnell JR, Dryer RF, et al. One-level versus 2-level treatment with cervical disc arthroplasty or fusion: Outcomes up to 7 years. Int J Spine Surg. 2019.
    1. Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD. 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. 2017;27(1):7–19.
    1. Gornet MF, Burkus JK, Shaffrey ME, Argires PJ, Nian H, Harrell FEJ. Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study. J Neurosurg Spine. 2015;23(5):558–73.
    1. Burkus JK, Traynelis VC, Haid RWJ, Mummaneni P V. 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.
    1. Mummaneni P V, 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. Loidolt T, Kurra S, Riew KD, Levi AD, Florman J, Lavelle WF. Comparison of adverse events between cervical disc arthroplasty and anterior cervical discectomy and fusion: a 10-year follow-up. Spine J. 2021.
    1. Lavelle WF, Riew KD, Levi AD, Florman JE. Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial. Spine (Phila Pa 1976). 2019;44(9):601–8.
    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. Orthopedics. 2011;34(11):889.
    1. Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, et al. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976). 2009;34(2):1740.
    1. Yin S, Yu X, Zhou S, Yin Z, Qiu Y. Is cervical disc arthroplasty superior to fusion for treatment of symptomatic cervical disc disease? A meta-analysis. Clin Orthop Relat Res. 2013;471(6):1904–19.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual life Res an Int J Qual life Asp Treat care Rehabil. 2011;20(10):1727–36.
    1. Versteegh MM, Vermeulen KM, Evers SMAA, de Wit GA, Prenger R, Stolk EA. Dutch tariff for the five-level version of EQ-5D. Value Heal J Int Soc Pharmacoeconomics Outcomes Res. 2016;19(4):343–352. doi: 10.1016/j.jval.2016.01.003.
    1. Hakkaart-van Roijen L, van der Linden N, Bouwmans C, Kanters TA, Tan SS. Kostenhandleiding: Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg. 2016.
    1. Zorginstituut Nederland. Richtlijn voor het uitvoeren van economische evaluaties in de gezondheidszorg. 2016.
    1. Zorginstituut Nederland. Kosteneffectiviteit in de praktijk. 2015.
    1. Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, Hakkaart-van Roijen L. The iMTA Productivity Cost Questionnaire: A Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses. Value Heal J Int Soc Pharmacoeconomics Outcomes Res. 2015;18(6):753–8.
    1. Hoefman RJ, van Exel NJA, Foets M, Brouwer WBF. Sustained informal care: the feasibility, construct validity and test-retest reliability of the CarerQol-instrument to measure the impact of informal care in long-term care. Aging Ment Health. 2011;15(8):1018–27.
    1. Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008;31(7):491–502.
    1. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (S. Arthritis Care Res (Hoboken). 2011;63 Suppl 1:S240-52.
    1. Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997;27(2):363–70.
    1. Tetreault L, Kopjar B, Nouri A, Arnold P, Barbagallo G, Bartels R, et al. The modified Japanese Orthopaedic Association scale: establishing criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy. Eur spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc. 2017;26(1):78–84.
    1. voor Neurochirurgie NV. Richtlijn: Behandeling van cervicaal radiculair syndroom ten gevolge van een cervicale hernia nuclei pulposi. 2010.
    1. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16(4):494–502. doi: 10.1136/ard.16.4.494.
    1. Le Huec JC, Thompson W, Mohsinaly Y, Barrey C, Faundez A. Sagittal balance of the spine. Eur spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc. 2019;28(9):1889–905.
    1. Kaiser MG, Mummaneni P V, Matz PG, Anderson PA, Groff MW, Heary RF, et al. Radiographic assessment of cervical subaxial fusion. J Neurosurgery-Spine. 2009;11(2):221–7.
    1. Gercek E, Arlet V, Delisle J, Marchesi D. Subsidence of stand-alone cervical cages in anterior interbody fusion: warning. Eur spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc. 2003;12(5):513–6.
    1. Saunders RP, Evans MH, Joshi P. Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract. 2005;6(2):134–47.
    1. Nunley PD, Jawahar A, Kerr EJ 3rd, Gordon CJ, Cavanaugh DA, Birdsong EM, et al. Factors affecting the incidence of symptomatic adjacent-level disease in cervical spine after total disc arthroplasty: 2- to 4-year follow-up of 3 prospective randomized trials. Spine (Phila Pa 1976). 2012;37(6):445–51.
    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: clinic. J Neurosurg Spine. 2013;19(5):532–45.
    1. Ishihara H, Kanamori M, Kawaguchi Y, Nakamura H, Kimura T. Adjacent segment disease after anterior cervical interbody fusion. Spine J. 2004;4(6):624–8.
    1. Arboned [Internet]. 2019. Available from: .
    1. Willan AR, Briggs AH. Statistical analysis of cost-effectiveness data, Vol. 37. Wiley; 2006.
    1. Cohen J. Statistical power analysis for the behavioral sciences. Academic press; 2013.
    1. Cepoiu-Martin M, Faris P, Lorenzetti D, Prefontaine E, Noseworthy T, Sutherland L. Artificial cervical disc arthroplasty: a systematic review. Spine (Phila Pa 1976). 2011;36(25):E1623-33.
    1. McAfee PC, Reah C, Gilder K, Eisermann L, Cunningham B. A meta-analysis of comparative outcomes following cervical arthroplasty or anterior cervical fusion: results from 4 prospective multicenter randomized clinical trials and up to 1226 patients. Spine (Phila Pa 1976). 2012;37(11):943–52.
    1. Upadhyaya CD, Wu J-C, Trost G, Haid RW, Traynelis VC, Tay B, et al. Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials. J Neurosurg Spine. 2012;16(3):216–28.
    1. Yu L, Song Y, Yang X, Lv C. Systematic review and meta-analysis of randomized controlled trials: comparison of total disk replacement with anterior cervical decompression and fusion. Orthopedics. 2011;34(10):e651-8.
    1. Jiang H, Zhu Z, Qiu Y, Qian B, Qiu X, Ji M. Cervical disc arthroplasty versus fusion for single-level symptomatic cervical disc disease: a meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg. 2012;132(2):141–51.
    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.
    1. Gornet MF, McConnell JR, Riew KD, Lanman TH, Burkus JK, Hodges SD, et al. Treatment of Cervical Myelopathy: Long-term Outcomes of Arthroplasty for Myelopathy Versus Radiculopathy, And Arthroplasty Versus Arthrodesis for Myelopathy. Clin spine Surg. 2018;31(10):420–7.
    1. Gornet MF, Riew KD, Lanman TH, Burkus JK, Hodges SD, McConnell JR, et al. Long-term outcomes of arthroplasty for cervical myelopathy versus radiculopathy, and arthroplasty versus arthrodesis for cervical myelopathy. Eur spine J [Internet]. 2017;Conference(2 Supplement 1 CC-Back and Neck):S330. Available from: .
    1. Goffin J, Casey A, Kehr P, Liebig K, Lind B, Logroscino C, et al. Preliminary clinical experience with the Bryan Cervical Disc Prosthesis. Neurosurgery. 2002;51(3):840–7.
    1. Jacobs W, Willems PC, van Limbeek J, Bartels R, Pavlov P, Anderson PG, et al. Single or double-level anterior interbody fusion techniques for cervical degenerative disc disease. Cochrane database Syst Rev. 2011;(1):CD004958.
    1. Radcliff K, Guyer RD. Economics of cervical disc replacement. Int J Spine Surg. 2020;14:S67–S72. doi: 10.14444/7093.

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