General Session: Innovative Technologies I - Hall F
Presented by: S. Blumenthal
(1) Texas Back Institute, Plano, TX, United States
Introduction: Degenerative disc disease (DDD) is a potentially debilitating condition resulting in pain and decreased functional ability in patients. Lumbar total disc replacement (TDR) helps to alleviate this pain and dysfunction and potentially allows for a return to pre-injury activities. This is the first study to our knowledge reporting on post-surgical quality of life (QoL) assessments at 7 years post-surgery.
Methods: As part of a large, multicenter clinical trial, eligible patients were randomly allocated (2:1) to treatment with an investigational TDR device (activL®, n=218) or FDA-approved control TDR devices (ProDisc-L, n=65 or Charité, n=41). Follow-up occurred at 6 weeks and 3, 6, 12 and 24 months and every year thereafter up to 7 years post-surgery. Patient QoL was evaluated using the SF-36 questionnaire. Data were also collected on patient satisfaction, work status and use of pain medication at baseline and at 7 year follow-up.
Results: At 7 years, 77% and 73% of activL and Control patients (respectively) showed improvements in mental component scores (MCS) for the SF-36 compared to baseline. Similarly, physical component scores (PCS) improved for 92% and 86% of activL and Control patients at 7 years post-surgery. Clinically significant improvements in MCS and PCS scores (≥15% improvement from baseline) occurred in approximately 44% (MCS) and 62% (PCS) of all TDR patients combined at 6 weeks, increased to 61% (MCS) and 80% (PCS) at 12 months and remained constant through to 7 years. Approximately 53% of all TDR patients returned to work without restriction by 12 months, which increased to 64% and 54% for activL and Control patients at 7 years. Most activL patients were able to return to the same workload as before their back injury at 7 years, whereas more Control patients worked in sedentary jobs at 7 years than before their back injury. Similar decreases in the proportion of patients utilizing pain medication were noted in both groups. At baseline, 90% and 92% of activL and Control patients were using medications for pain control, which decreased by half by 7 years. Patient satisfaction at 7 years post-surgery showed 97% of all TDR patients were "very satisfied" or "somewhat satisfied" with the procedure, and 93% indicated that they would "definitely" or "probably" undergo the procedure again for the same condition. 97% of activL and 89% of Control patients indicated that the treatment was "very" or "moderately" effective in eliminating their symptoms.
Conclusions: The results of this analysis indicate that lumbar TDR is effective at helping to improve patient's quality of life, potentially facilitating return to work and reducing pain medication usage.