Abstract
Introduction
The main objective of this study is long-term evaluation of clinical outcome of total disk replacement (TDR) compared to posterior fusion in surgical treatment at chronic low back pain (CLBP) due to degenerative disk disease.
Materials and Methods
The study is a prospective randomized controlled trial comprising 152 patients; 80 were randomized to TDR and 72 to fusion. Mean age was 40 years (21 to 55) and 59% were women. All patients suffered from CLBP with varying degrees of leg pain and had not responded to a nonsurgical treatment program.
Diagnosis was based on clinical examination, radiographs, and MRI.
Primary outcome measure was global assessment (GA) of back pain and secondary outcome measures were back and leg pain, Oswestry Disability Index (ODI), EQ5D, and SF-36. All measures were collected from SweSpine, the Swedish national register for spinal surgery, at 1, 2, and 5 years. Follow-up rate at 5 years were 99.3% with no crossover.
Results
Both groups showed clinical improvement at 5-year follow-up. There was no deterioration over time. Regarding GA, 38% (30/80) in the TDR group was totally pain free vs. 15% (11/71) in the fusion group (p < 0.003). Back pain and improvement of back pain were better in the TDR group (23 ± 29 vs. 31 ± 27, p = 0.008). ODI and improvement in ODI were also better in the TDR group (ODI at 5 years 17 ± 19 vs. 23 + 17, p = 0.016,) (ODI diff 5 years 25 ± 18 vs. 18 ± 19 (p = 0.019).
EQ-5D and VAS leg pain also showed significantly better improvement in the TDR group. Achievement of surgical goal (nonmobile fusions) at 2 years was not related to clinical outcome neither at 2 nor at 5 years. Achievement of surgical goal (mobile disk arthroplasties) at 2 years was related to greater improvement in back pain at 5 years. There was no difference in complications between the two groups. A difference was registered between the two groups in numbers of reoperation. A total of 16% (13/80) in the TDR group had undergone one or more reoperation compared to 31% (22/72) in the fusion group ( p = 0.365).
Conclusion
Global assessment of back differed between the two surgical groups at all follow-up occasions. The difference between groups concerning back pain, pain improvement and ODI had been present at 1 year, disappeared after 2 years but reappeared at the 5-year follow-up. There is no deterioration of results over time.
No
None declared