Thursday, September 27, 2018 3:35 PM–5:05 PM section on motion technology abstract presentations: 131. Analysis of reoperations after cervical total disc replacement in a consecutive series of 504 patients

Abstract

BACKGROUND CONTEXT 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. PURPOSE The purpose of this study was to determine the re-operation rate for a series of cervical TDR patients. STUDY DESIGN/SETTING The study was conducted at a multi-site spine specialty clinic. Surgery records were reviewed to identify cervical TDR patients and those who underwent subsequent surgery. PATIENT SAMPLE Cervical TDR cases involving ProDisc-C (Centinel Spine) were identified, beginning with the first case performed in 2003 at a multisite spine specialty center. Only patients who were at least 2 years postoperative were included, producing a consecutive of 504 patients. The number of levels operated was: one level in 463 patients, two levels in 39 patients and three levels in two patients. There were 112 hybrids in the series (TDR at one level and fusion at an adjacent segment). OUTCOME MEASURES The primary outcome measure was the occurrence of a re-operation. METHODS Data collected included general demographics, level(s) operated, and blood loss. A surgery log through 12-31-17 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 form the index surgery to the search of the surgery log for re-operations was 69.4 months, range 24 to 169 months. RESULTS Re-operation occurred in 28 patients (5.5%). These included: three TDR removals and ACF performed (one for migration, one subsidence, and one spondylosis), one TDR repositioning, 20 adjacent segment degeneration (five of which were hybrid procedures or fusion prior to TDR), one wound infection, one hematoma and two received stimulators for pain control. There were no re-operations for device failure. The mean duration between the index surgery and re-operation at an adjacent segment was 44.8 months. CONCLUSIONS The re-operation rate was relatively low at 5.5%, none of which were performed for device failure. These results support the safety of this device.