Abstract
Introduction
The role of fusion of lumbar motion segments for the treatment of intractable low back pain (LBP) from degenerative disc disease (DDD) remains controversially debated. Total lumbar disc replacement (TDR) has been used as an alternative in a highly selected patient cohort. However, the amount of long-term follow-up (FU) data on TDR is limited.
Materials and Methods
Visual analog scale (VAS), Oswestry disability index (ODI) and patient satisfaction rates were acquired within the framework of an ongoing prospective clinical trial. The patient's professional activity/employment status, complications, and reoperations were recorded. A comparison was performed between mono- and bisegmental cases.
Results
The initial cohort consisted of 201 patients; 181 patients were available for final FU (90.0% FU rate) after a mean FU of 7.4 years (range, 5.0-10.8 years). VAS and ODI scores revealed a highly significant improvement from baseline levels at all postoperative stages (p < 0.0001). VAS scores demonstrated a slight (VAS 2.6-3.3) but statistically significant deterioration from 48 months onward (p < 0.05). Patient satisfaction rates remained stable throughout the entire postoperative course, with 63.6% of patients reporting a “highly satisfactory” or a “satisfactory outcome” (22.7%), while 13.7% of patients were not satisfied.
The overall complication rate was 14.4% (n = 26/181). The incidence of revision surgeries for general and/or device related complications was 7.2% (n = 13/181).
Results for two-level TDR were significantly inferior in comparison with one-level cases and were associated with higher complication (11.9 vs. 27.6%; p = 0.03) and inferior satisfaction rates (p < 0.003).
Conclusion
Despite the fact that the current data comprise the early experiences and learning curve associated with a new surgical technique, the results demonstrate satisfactory and maintained mid- to long-term clinical results after a mean FU of 7.4 years. Patient safety was proven with acceptable complication and reoperation rates. Fear of excessive late complications or reoperations following the primary TDR procedure cannot be substantiated with the present data.
In carefully selected cases, TDR can be considered a viable treatment alternative to lumbar fusion for which spine communities around the world seem to have accepted mediocre clinical results as well as obvious and significant drawbacks.
None declared