No abstract

ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria.

Five-year results show that TDR with ProDisc-C is a safe and effective treatment of single-level symptomatic cervical disc disease. Clinical outcomes were comparable with ACDF. ProDisc-C patients maintained motion at the index level and had significantly less neck pain intensity and frequency as well as a lower probability of secondary surgery.

Object The purpose of this study was to evaluate the long-term safety and effectiveness of the ProDisc-L total disc replacement (TDR) as part of an FDA-mandated postmarket approval study. This report summarizes the clinical findings after 5 years of follow-up. Methods Two hundred thirty-six patients were treated and followed up for 5 years; 161 TDRs and 75 fusions had been performed in these patients. The primary outcome was a 10-component success end point. Secondary outcome measures included neurological status, secondary surgery, Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), visual analog scale (VAS) assessing pain and satisfaction, radiographic data, narcotic use, activity, and recreation status. Patients were monitored through their 5-year postoperative visits under the FDA postmarket surveillance provisions in the original investigational device exemption approval. Results The overall follow-up rate at 5 years was 81.8%. Study success demonstrated that TDR was noninferior to fusion with a 12.5% margin (p = 0.0099). Both TDR and fusion treatment groups maintained significant improvement on the ODI at 5 years compared with baseline (p < 0.0001). Secondary surgeries at the index level were performed in 12% of fusion patients and 8% of TDR patients. Radiographically, none of the TDRs developed spontaneous fusion. The segmental range of motion following TDR remained within normal range, although it decreased by approximately 0.5° in years 3 to 5. The VAS pain scores decreased from preoperative values by 48% in both treatment groups at 5 years. Patient satisfaction remained high in both groups (77%), while the percentage of patients indicating that they would have the surgery again was higher in TDR patients (82.5%) than in fusion patients (68.0%). Conclusions Patients in both groups maintained significant improvement during the 5-year follow-up. The TDR group had significantly better improvement on some scales. Although TDR patients avoid the stiffness of fusion and are more satisfied than fusion patients, both fusion and TDR are reasonable surgical options in this specific patient population.

IntroductionThere is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up.

Despite the relatively short duration of follow-up and design limitations, the present study suggests that two-level lumbar disc arthroplasty is an alternative to and offers clinical advantages in terms of pain relief and functional recovery in comparison with arthrodesis. Longer-term follow-up is needed to determine the risks for implant wear and/or degenerative segment changes.

Five-year follow-up of a prospective randomized clinical trial revealed 5-fold difference in reoperation rates when comparing patients who underwent ACDF (14.5%) with patients who underwent TDR (2.9%). These findings suggest the durability of TDR and its potential to slow the rate of adjacent-level disease.

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.