Analysis of re-operations after cervical total disc replacement in a consecutive series of 535 patients receiving the Pr
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ORIGINAL ARTICLE
Analysis of re‑operations after cervical total disc replacement in a consecutive series of 535 patients receiving the ProDisc‑C device Jack E. Zigler1 · Richard D. Guyer1 · Scott L. Blumenthal1 · Donna D. Ohnmeiss1,2 Received: 22 November 2019 / Accepted: 27 March 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
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. Keywords Total disc replacement · Cervical spine · Re-operations
Introduction Anterior cervical discectomy and fusion (ACDF) has long been a well-accepted surgical treatment for painful degenerative conditions of the cervical spine after failure of non-operative care. It has a reasonable safety profile with a generally acceptable re-operation rate. The most common reasons for re-operation are pseudoarthrosis and adjacent
* Jack E. Zigler [email protected] 1
Center for Disc Replacement at Texas Back Institute, 6020 W. Parker Rd. #200, Plano, TX 75093, USA
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