Abstract
Introduction
One important factor in evaluating the safety of an implant is the rate of subsequent surgery and the reasons for surgery, particularly those that are related to possible problems with the implant. The purpose of this study was to determine the overall re-operation rate (including revisions, removals, device-related, procedure-related, adjacent segment, and others) for a large consecutive series of cervical TDR patients beginning with the first case experience, using a single device at a single institution.
Methods
Surgery records were reviewed to identify cervical TDR patients and those who underwent subsequent surgery. Cervical TDR cases involving ProDisc-C were identified, beginning with the first case performed in 2003 at a multisite spine specialty centre. Only patients who were at least 2 years post-operative were included, producing a consecutive series of 535 patients. There were 115 hybrids in the series (TDR at one level and fusion at an adjacent segment). Data collected included general demographics and level(s) operated. A surgery log through 12-31-18 was reviewed to identify re-operations occurring in the TDR patients. For each re-operation, the reason, duration from index surgery, and procedure were recorded. The mean duration from the index surgery to the search of the surgery log for re-operations was 78.3 months, range 24 to 181 months.
Results
Re-operation occurred in 30 patients (5.6%). These included: 3 TDR removals and revision to anterior discectomy and fusion (1 for migration, 1 for subsidence, and 1 for spondylosis), 1 TDR repositioning, 21 secondary surgeries for adjacent segment degeneration (5 of which were adjacent to fusion levels in hybrid procedures), 1 wound infection, 1 hematoma, and 2 received stimulators for pain control. There were no re- operations for device failure. In cases of re-operation for adjacent segment degeneration, the mean duration between the index surgery and re-operation was 47.3 months.
Conclusion
The re-operation rate was 5.6%. No surgeries were performed for device failure. These results support the safety of the TDR device.
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References
Anderson PA, Nassr A, Currier BL, Sebastian AS, Arnold PM, Fehlings MG, Mroz TE, Riew KD (2017) Evaluation of adverse events in total disc replacement: a meta-analysis of FDA summary of safety and effectiveness data. Global Spine J 7(1 Suppl):76s–83s. https://doi.org/10.1177/2192568216688195
Blumenthal SL, Ohnmeiss DD, Guyer RD, Zigler JE (2013) Re-operations in cervical total disc replacement compared with anterior cervical fusion: results compiled from multiple prospective FDA IDE trials conducted at a single site. Spine 38(14):1177–1182
Loumeau TP, Darden BV, Kesman TJ, Odum SM, Van Doren BA, Laxer EB, Murrey DB (2016) 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 25(7):2263–2270
Skeppholm M, Henriques T, Tullberg T (2017) Higher reoperation rate following cervical disc replacement in a retrospective, long-term comparative study of 715 patients. Eur Spine J 26(9):2434–2440. https://doi.org/10.1007/s00586-017-5218-0
Coric D, Guyer RD, Nunley PD, Musante D, Carmody C, Gordon C, Lauryssen C, Boltes MO, Ohnmeiss DD (2018) Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc. J Neurosurg Spine 28(3):252–261. https://doi.org/10.3171/2017.5.spine16824
Jackson RJ, Davis RJ, Hoffman GA, Bae HW, Hisey MS, Kim KD, Gaede SE, Nunley PD (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):734–745. https://doi.org/10.3171/2015.8.spine15219
Zhong ZM, Zhu SY, Zhuang JS, Wu Q, Chen JT (2016) Reoperation after cervical disc arthroplasty versus anterior cervical discectomy and fusion: a meta-analysis. Clin Orthop Relat Res 474(5):1307–1316. https://doi.org/10.1007/s11999-016-4707-5
Park JB, Chang H, Yeom JS, Suk KS, Lee DH, Lee JC (2016) Revision surgeries following artificial disc replacement of cervical spine. Acta OrthopaedicaTraumatologica Turcica 50(6):610–618. https://doi.org/10.1016/j.aott.2016.04.004
Ohnmeiss DD, Guyer RD, Blumenthal SL, Zigler JE (2016) Reoperation rates in lumbar spine surgery: statistically significant differences exist in the same dataset when different definitions for reoperation are applied. Spine J 16(10):S292. https://doi.org/10.1016/j.spinee.2016.07.214
Hilibrand AS, Carlson GD, Palumbo MA, Jones PK, Bohlman HH (1999) Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am 81(4):519–528
Xu S, Liang Y, Zhu Z, Qian Y, Liu H (2018) Adjacent segment degeneration or disease after cervical total disc replacement: a meta-analysis of randomized controlled trials. J Orthop Surg Res 13(1):244. https://doi.org/10.1186/s13018-018-0940-9
Chang KE, Pham MH, Hsieh PC (2017) Adjacent segment disease requiring reoperation in cervical total disc arthroplasty: a literature review and update. J Clin Neurosci 37:20–24. https://doi.org/10.1016/j.jocn.2016.10.047
Ghobrial GM, Lavelle WF, Florman JE, Riew KD, Levi AD (2019) 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. Neurosurgery 84(2):347–354. https://doi.org/10.1093/neuros/nyy118
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):213–224. https://doi.org/10.3171/2015.12.spine15824
Burkus JK, Traynelis VC, Haid RW Jr, Mummaneni PV (2014) 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(4):516–528
Zhu RS, Kan SL, Cao ZG, Jiang ZH, Zhang XL, Hu W (2018) Secondary surgery after cervical disc arthroplasty versus fusion for cervical degenerative disc disease: a meta-analysis with trial sequential analysis. Orthop Surg 10(3):181–191. https://doi.org/10.1111/os.12401
Radcliff K, Lerner J, Yang C, Bernard T, Zigler JE (2016) Seven-year cost-effectiveness of ProDisc-C total disc replacement: results from investigational device exemption and post-approval studies. J Neurosurg Spine 24(5):760–768. https://doi.org/10.3171/2015.10.spine15505
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Jack Zigler MD, Scott Blumenthal MD, and Richard Guyer MD are consultants for Centinel Spine. Donna Ohnmeiss Dr Med receives institutional research support from Centinel Spine.
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Zigler, J.E., Guyer, R.D., Blumenthal, S.L. et al. Analysis of re-operations after cervical total disc replacement in a consecutive series of 535 patients receiving the ProDisc-C device. Eur Spine J 29, 2683–2687 (2020). https://doi.org/10.1007/s00586-020-06399-3
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DOI: https://doi.org/10.1007/s00586-020-06399-3