Wednesday, September 26, 2018 3:35 PM – 5:05 PM Preserving Spinal Motion: 88. Cervical artificial disc replacement with Prodisc-C: 10-year clinical and radiographic results of prospective observational study in a single institute

Abstract

BACKGROUND CONTEXT Cervical artificial disc replacement (ADR) is indicated for the treatment of severe radiculopathy permitting neural decompression and maintenance of motion. Previous reports of short and mid-term results have shown that cervical ADR using Prodisc-C is safe and effective in symptomatic CDD between C3 and C7 PURPOSE The objective of this study is to evaluate long-term clinical and radiologic results of ADR using the Prodisc-C in patients with single-level cervical disc disease (CDD) in minimum 10-year follow-up. STUDY DESIGN/SETTING This study is a retrosepctive observational analyisis of prespective registry. PATIENT SAMPLE Data were collected through a prospective registry, with retrospective analysis performed on 79 consecutive patients treated with cervical ADR with the Prodisc-C device (DePuy Synthes, West Chester, PA, USA) in a single institution. OUTCOME MEASURES Clinical outcome measures included visual analog scale (VAS) for neck and arm pain and Owestry Disability Index (ODI). Serial flexion-extension cervical radiographs and CT scans were performed to assess range of motion (ROM) of index segment, adjacent segment degenerations (ASD), implant-related complications (migration, subsidence, lucency) and heterotopic ossification (HO) using McAfee classification system. METHODS All enrollees were evaluated pre- and postoperatively at regular intervals using both clinical and radiologic parameters. RESULTS Out of 79 patients enrolled, 79.7% (63/79) continued regular outpatient visits at the 5-year follow-up period. However, after 10 years, only 22.9% (17/71) of patients remained with the study. Average follow-up was 10.7 years. After 5-year follow-up, neck and arm pain improved 68.6% and 86.8%, respectively, and ODI had an improvement of 85.7%. However, after the last visit, neck pain improvement decreased to 29.7%, whereas arm pain and ODI remained at 74.6% and 68.9%, respectively. Neurologic success rate was 82.3% after final assessment. There were no episodes of device failure except one case of subsidence. Mean ROM of the device decreased from 6.7°at 5-year to 5.4°at final assessment. Radiographic ASD developed in 58.8% of patients (mild; 29.4%, moderate; 23.5%, severe; 5.8%, respectively) and 58.8% demonstrated HO at the final follow-up, however, only 17.6% were symptomatic requiring second surgery. CONCLUSIONS The Prodisc-C device for cervical ADR appears to be safe and effective for the treatment of CDD after long-term follow-up. Despite radiographic evidence of ASD and HO on final assessment, Prodisc-C ADR provided maintenance of segmental motion at the index level and good neurologic success rate. FDA DEVICE/DRUG STATUS Prodisc-C: FDA status unavailable from the author at press time.