Addition of TLIF does not improve outcome over standard posterior instrumented fusion. 5-10 years long-term Follow-up: results from a RCT

The use of inter-body device in lumbar fusions has been difficult to validate, only few long-term RCT are available. Between 2003 and 2005, 100 patients entered a RCT between transforaminal lumbar inter-body fusion (TLIF) or posterolateral instrumented lumbar fusion (PLF). The patients suffered from LBP due to segmental instability, disc degeneration, former disc herniation, spondylolisthesis Meyerding grade < 2. Functional outcome parameters as Dallas pain questionnaire (DPQ), SF-36, low back pain questionnaire (LBRS), Oswestry disability index (ODI) were registered prospectively, and after 5-10 years. Follow-up reached 93 % of available, (94 %, 44 in the PLF's and 92 %, 44 in the TLIF group p = 0.76). Mean follow-up was 8.6 years (5-10 years). Mean age at follow-up was 59 years (34-76 years p = 0.19). Reoperation rate in a long-term perspective was equal among groups 14 %, each p = 0.24. Back pain was 3.8 (mean) (Scale 0-10), TLIF (3.65) PLF (3.97) p = 0.62, leg pain 2.68 (mean) (Scale 0-10) 2.90 (TLIF) and 2.48 (PLF) p = 0.34. No difference in functional outcome between groups p = 0.93. Overall, global satisfaction with the primary intervention at 8.6 year was 76 % (75 % TLIF and 77 % PLF) p = 0.85. In a long-term perspective, patients with TLIF's did not experience better outcome scores.