Lateral interbody fusion in the lumbar spine for low back pain

4 Efficacy

This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 In a systematic review of 237 articles on lateral lumbar interbody fusion, the weighted average for the rate of fusion in all patients was 94% (n=907 patients; 22 study arms).

4.2 In the systematic review of 237 articles, the weighted average for improvement in pain, measured on a visual analogue scale, was 60% (n=2,097 patients; 41 study arms). In a non-randomised comparative study of 202 patients treated by extreme lateral interbody fusion (LIF) or open anterior lumbar interbody fusion (ALIF), low back pain scores, measured on a scale of 0–10, improved from 7.5 at baseline in both groups (n=95) to 2.4 and 2.6 respectively at 12‑month follow-up (n=61; p<0.001 compared with baseline; p=not significant for between group comparison). Mean leg pain, measured on a scale of 0–10, improved from 5.8 in the extreme LIF group and 5.4 in the ALIF group at baseline (n=95) to 1.6 and 2.0 respectively at 12‑month follow-up (n=61), in the same study (p<0.001 compared with baseline; p value not significant for between group comparison).

4.3 In the systematic review of 237 articles, the weighted average for improvement in disability, measured on the Oswestry Disability Index (ODI), was 48% (n=1,234 patients; 29 study arms). In the non-randomised comparative study of 202 patients treated by extreme LIF or ALIF, the ODI improved from 59% at baseline in both groups (n=95) to 23% and 24% respectively at 12‑month follow-up (n=61; p<0.001 compared with baseline; p value not significant for between group comparison). In a case series of 160 patients, the ODI improved from 44% at baseline to 23.5% at the last follow-up (mean follow-up 18.5 months; p value not reported).

4.4 In the systematic review of 237 articles, the weighted average for patient satisfaction was 89% (n=491 patients; 9 study arms); 85% of patients said that they would have the procedure again if their outcome had been known in advance. In a randomised controlled trial (RCT) and non‑randomised comparative study of 55 patients treated by extreme LIF or transforaminal interbody fusion (TLIF), 91% and 80% of patients respectively were satisfied with their outcome at 24‑month follow-up (p=0.393) and 100% and 90% of patients respectively would be willing to have the same procedure had their outcome been known in advance (p=0.210). In a non-randomised comparative study of 208 patients treated by extreme LIF or ALIF, 95% (198/208) of patients were satisfied with the procedure and reported improvement; 10 patients did not improve or worsened (radiological and clinical results were similar in both groups).

4.5 In the RCT and non‑randomised comparative study of 55 patients treated by extreme LIF or TLIF, mean quality-of-life scores for the SF‑36 physical component improved from 37.7 and 39.5 respectively at baseline to 61.4 and 64.9 at 24‑month follow-up (p<0.05 compared with baseline). Mean quality-of-life scores for the SF‑36 mental component improved from 51 and 52.2 respectively at baseline to 67.2 and 69.2 at 24‑month follow-up (p<0.05 compared with baseline). In the case series of 160 patients, the SF‑36 physical component score improved from 30.9 at baseline to 43.2 at the last follow-up (mean follow-up 18.5 months; p value not reported).

4.6 The specialist advisers listed the key efficacy outcomes as patient reported outcome measures, including reduced pain, and radiological outcomes, including fusion of the lumbar spine and restoration of the disc height.