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

Kris Radcliff Department of Orthopedic Surgery, Thomas Jefferson University, Rothman Institute, Egg Harbor, New Jersey;

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Domagoj Coric Carolinas Medical Center, Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina; and

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Todd Albert Hospital for Special Surgery, Weill Cornell Medical College, New York, New York

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OBJECTIVE

The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement.

METHODS

This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor.

RESULTS

A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups.

CONCLUSIONS

Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients.

Clinical trial registration no. NCT00389597 (clinicaltrials.gov)

ABBREVIATIONS

ACDF = anterior cervical discectomy and fusion; cTDR = cervical total disc replacement; IDE = investigational device exemption; MCS = Mental Component Summary; NDI = Neck Disability Index; PCS = Physical Component Summary; ROM = range of motion; SF-12 = 12-Item Short Form Health Survey; VAS = visual analog scale.

Supplementary Materials

    • Appendices 1 and 2 (PDF 657 KB)
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  • 1

    Anderson PA, , Sasso RC, , Hipp J, , Norvell DC, , Raich A, & Hashimoto R: Kinematics of the cervical adjacent segments after disc arthroplasty compared with anterior discectomy and fusion: a systematic review and meta-analysis. Spine (Phila Pa 1976) 37:22 Suppl S85S95, 2012

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2

    Auerbach JD, , Anakwenze OA, , Milby AH, , Lonner BS, & Balderston RA: Segmental contribution toward total cervical range of motion: a comparison of cervical disc arthroplasty and fusion. Spine (Phila Pa 1976) 36:E1593E1599, 2011

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3

    Barrey C, , Campana S, , Persohn S, , Perrin G, & Skalli W: Cervical disc prosthesis versus arthrodesis using one-level, hybrid and two-level constructs: an in vitro investigation. Eur Spine J 21:432442, 2012

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4

    Beaurain J, , Bernard P, , Dufour T, , Fuentes JM, , Hovorka I, & Huppert J, et al.: Intermediate clinical and radiological results of cervical TDR (Mobi-C) with up to 2 years of follow-up. Eur Spine J 18:841850, 2009

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5

    Boselie TF, , Willems PC, , van Mameren H, , de Bie R, , Benzel EC, & van Santbrink H: Arthroplasty versus fusion in single-level cervical degenerative disc disease. Cochrane Database Syst Rev 9:CD009173, 2012

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6

    Botelho RV, , Moraes OJ, , Fernandes GA, , dos Santos Buscariolli Y, & Bernardo WM: A systematic review of randomized trials on the effect of cervical disc arthroplasty on reducing adjacent-level degeneration. Neurosurg Focus 28:6 E5, 2010

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7

    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 clinical trial. J Neurosurg Spine 13:308318, 2010

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8

    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 21:516528, 2014

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9

    Cardoso MJ, & Rosner MK: Multilevel cervical arthroplasty with artificial disc replacement. Neurosurg Focus 28:E19, 2010

  • 10

    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 15:348358, 2011

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11

    Cunningham BW, , Hu N, , Zorn CM, & McAfee PC: Biomechanical comparison of single- and two-level cervical arthroplasty versus arthrodesis: effect on adjacent-level spinal kinematics. Spine J 10:341349, 2010

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 12

    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 19:532545, 2013

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13

    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) 38:711717, 2013

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 14

    Fallah A, , Akl EA, , Ebrahim S, , Ibrahim GM, , Mansouri A, & Foote CJ, et al.: Anterior cervical discectomy with arthroplasty versus arthrodesis for single-level cervical spondylosis: a systematic review and meta-analysis. PLoS One 7:e43407, 2012

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15

    Harrod CC, , Hilibrand AS, , Fischer DJ, & Skelly AC: Adjacent segment pathology following cervical motion-sparing procedures or devices compared with fusion surgery: a systematic review. Spine (Phila Pa 1976) 37:22 Suppl S96S112, 2012

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16

    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) 34:101107, 2009

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17

    Huppert J, , Beaurain J, , Steib JP, , Bernard P, , Dufour T, & Hovorka I, et al.: Comparison between single- and multilevel patients: clinical and radiological outcomes 2 years after cervical disc replacement. Eur Spine J 20:14171426, 2011

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18

    Jawahar A, , Cavanaugh DA, , Kerr EJ III, , 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 10:10431048, 2010

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19

    Kepler CK, , Brodt ED, , Dettori JR, & Albert TJ: Cervical artificial disc replacement versus fusion in the cervical spine: a systematic review comparing multilevel versus single-level surgery. Evid Based Spine Care J 3:S1 1930, 2012

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20

    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 (Phila Pa 1976) 37:22 Suppl S52S64, 2012

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21

    McAfee PC, , Cappuccino A, , Cunningham BW, , Devine JG, , Phillips FM, & Regan JJ, et al.: Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. J Spinal Disord Tech 23:18, 2010

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22

    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 cervical disc disease. Spine J 9:275286, 2009

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23

    Park JH, , Rhim SC, & Roh SW: Mid-term follow-up of clinical and radiologic outcomes in cervical total disk replacement (Mobi-C): incidence of heterotopic ossification and risk factors. J Spinal Disord Tech 26:141145, 2013

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24

    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) 40:674683, 2015

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 25

    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) 38:E907E918, 2013

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 26

    Phillips FM, , Tzermiadianos MN, , Voronov LI, , Havey RM, , Carandang G, & Dooris A, et al.: Effect of two-level total disc replacement on cervical spine kinematics. Spine (Phila Pa 1976) 34:E794E799, 2009

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 27

    Pimenta L, , McAfee PC, , Cappuccino A, , Cunningham BW, , Diaz R, & Coutinho E: Superiority of multilevel cervical arthroplasty outcomes versus single-level outcomes: 229 consecutive PCM prostheses. Spine (Phila Pa 1976) 32:13371344, 2007

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 28

    Pracyk JB, & Traynelis VC: Treatment of the painful motion segment: cervical arthroplasty. Spine (Phila Pa 1976) 30:16 Suppl S23S32, 2005

  • 29

    Radcliff K, , Zigler J, & Zigler J: Costs of cervical disc replacement versus anterior cervical discectomy and fusion for treatment of single-level cervical disc disease: an analysis of the Blue Health Intelligence database for acute and long-term costs and complications. Spine (Phila Pa 1976) 40:521529, 2015

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 30

    Reitman CA, , Hipp JA, , Nguyen L, & Esses SI: Changes in segmental intervertebral motion adjacent to cervical arthrodesis: a prospective study. Spine (Phila Pa 1976) 29:E221E226, 2004

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 31

    Rihn JA, , Radcliff K, , Hipp J, , Vaccaro AR, , Hilibrand AS, & Anderson DG, et al.: Radiographic variables that may predict clinical outcomes in cervical disk replacement surgery. J Spinal Disord Tech 28:106113, 2015

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 32

    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 3:417423, 2005

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 33

    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 93:16841692, 2011

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 34

    Sasso RC, , Metcalf NH, , Hipp JA, , Wharton ND, & Anderson PA: Sagittal alignment after Bryan cervical arthroplasty. Spine (Phila Pa 1976) 36:991996, 2011

  • 35

    Singh K, , Phillips FM, , Park DK, , Pelton MA, , An HS, & Goldberg EJ: Factors affecting reoperations after anterior cervical discectomy and fusion within and outside of a Federal Drug Administration investigational device exemption cervical disc replacement trial. Spine J 12:372378, 2012

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 36

    Somerson JS, , Bhandari M, , Vaughan CT, , Smith CS, & Zelle BA: Lack of diversity in orthopaedic trials conducted in the United States. J Bone Joint Surg Am 96:e56, 2014

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 37

    Vaccaro A, , Beutler W, , Peppelman W, , Marzluff JM, , High-smith J, & Mugglin A, et al.: 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) 38:22272239, 2013

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 38

    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) 38:22532257, 2013

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 39

    Wang JC, , McDonough PW, , Endow KK, & Delamarter RB: A comparison of fusion rates between single-level cervical corpectomy and two-level discectomy and fusion. J Spinal Disord 14:222225, 2001

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 40

    Wang JC, , McDonough PW, , Endow KK, & Delamarter RB: Increased fusion rates with cervical plating for two-level an terior cervical discectomy and fusion. Spine (Phila Pa 1976) 25:4145, 2000

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 41

    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) 38:203209, 2013

    • PubMed
    • Search Google Scholar
    • Export Citation

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