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)
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The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7.
We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed.
Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group.
The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.
KeywordsClinical trial Symptomatic cervical disc disease Total disc arthroplasty ProDisc-C Anterior cervical discectomy and fusion Outcomes
This study is part of a multicenter US Food and Drug Administration investigational device exemption study funded by Synthes Spine, West Chester, PA, USA.
Compliance with ethical standards
Conflict of interest
The authors wish to acknowledge the following potential conflicts of interest: Paid consultant: 4Web, Spineguard, Stryker; Unpaid consultant: BioMedFlex, OrthoMedFlex; Paid speaker or presenter: Stryker, Synthes; IP royalties: Stryker; Research support: DePuy: A Johnson & Johnson Company, Synthes; Stock or stock options: BioMedFlex, 4Web, Amedica, OrthoMedFlex; Board member: Cervical Spine Research Society, Lumbar Spine Research Society, American Association of Hip & Knee Surgeons; Editorial board: Journal of Arthroplasty, Journal of Spinal Disorders & Techniques, Journal of Spinal Cord Medicine, Journal of the American Association of Orthopedic Surgeons.
- 6.Murrey D, Janssen M, Delamarter R, Goldstein J, Zigler J, Tay B, Darden B (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 9:275–286. doi: 10.1016/j.spinee.2008.05.006 CrossRefPubMedGoogle Scholar
- 7.Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M (2013) 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 38:203–209. doi: 10.1097/BRS.0b013e318278eb38 CrossRefPubMedGoogle Scholar
- 9.Gao Y, Liu M, Li T, Huang F, Tang T, Xiang Z (2013) 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 95-A:555–561. doi: 10.2106/JBJS.K.00599 CrossRefGoogle Scholar
- 11.Nunley PD, Jawahar A, Kerr EJ 3rd, Gordon CJ, Birdsong EM, Stocks M, Danielson G (2012) 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 37:445–451. doi: 10.1097/BRS.0b013e31822174b3 CrossRefPubMedGoogle Scholar
- 12.Nunley PD, Jawahar A, Cavanaugh DA, Gordon CR, Kerr EJ 3rd, Utter PA (2013) Symptomatic adjacent segment disease after cervical total disc replacement: re-examining the clinical and radiological evidence with established criteria. Spine J 13:5–12. doi: 10.1016/j.spinee.2012.11.032 CrossRefPubMedGoogle Scholar
- 13.Park JY, Kim KH, Kuh SU, Chin DK, Kim KS, Cho YE (2013) What are the associative factors of adjacent segment degeneration after anterior cervical spine surgery? Comparative study between anterior cervical fusion and arthroplasty with five-year follow-up MRI and CT. Eur Spine J 22:1078–1089. doi: 10.1007/s00586-012-2613-4 CrossRefPubMedGoogle Scholar
- 14.Janssen ME, Zigler JE, Spivak JM, Delamarter RB, Darden BV II, Kopjar B (2015) ProDisc-C total disc replacement versus anterior cervical discectomy and fusion for single-level sympotmatic certical disc disease. J Bone Joint Surg Am 97:1738–1747. doi: 10.2106/JBJS.N.01186 CrossRefPubMedGoogle Scholar
- 19.Guyer RD, Shellock J, MacLennan B, Hanscom D, Knight RQ, McCombe P, Jacobs JJ, Urban RM, Bradford D, Ohnmeiss DD (2011) Early failure of metal-on-metal artificial disc prostheses associated with lymphocytic reaction: diagnosis and treatment experience in four cases. Spine 36:E492–E497. doi: 10.1097/BRS.0b013e31820ea9a2 CrossRefPubMedGoogle Scholar