Abstract
Recent published RCTs have created uncertainty around the appropriate utilization of lumbar fusion when performing a laminectomy for symptomatic lumbar degenerative spondylolisthesis. SLIP II is an RCT that explores how spinal expert review might help to classify patients as most appropriate for fusion versus decompression alone.
To determine if use of a surgical expert review panel recommending fusion might reduce surgical failures.
We performed a multi-center prospective RCT at 14 sites.
Patients (age > 18 years) with symptomatic lumbar stenosis with degenerative spondylolisthesis were enrolled.
Outcomes (EQ-5D and ODI) were assessed preoperatively, 3 months, 6 months, 12 months, and 24 months. NASS patient satisfaction was also assessed at 1 year.
Patients were randomized to either receive an expert panel review of their case or not. Spinal expert review consisted of 10-15 surgeons’ review of patient imaging and history regarding appropriateness of fusion that was shared with both treating surgeon and patient. Patients had surgical treatment at the discretion of the treating surgeon. Analysis was focused upon whether a strong majority (>80% consensus) of spinal experts recommending fusion might reduce operative failures. Operative failure was defined as no improvement or worsening of ODI or EQ5D score.
Fourteen sites randomized 662 patients. One-year follow-up was 82%. 321 underwent review and 341 no review. Mean age was 66 years (59.7% female). Baseline characteristics were comparable. Overall, fusion was performed on 418/662 (63.1%) of patients. For patients randomized to an expert review- fusion was strongly recommended in 102/232 (44%) of cases, and in 91/102 (89%) of cases, fusion was performed as recommended. Super majority recommendation for fusion (SM) outcome was compared to patients in the control group (no review). SM was associated with –25.5-point ODI change vs –23.8-point ODI change (p=0.485) and 0.302 change in Eq5D vs 0.250 change in Eq5D (p=0.089). The proportion of failure in fusion with super majority review measured by ODI score was 6.6% vs 14.9% in nonreview group (p=0.067). The proportion of failure in fusion with super majority review measured by EQ-5D score was 7.9% vs 18.8% in nonreview group (p=0.036; Figure 1). NASS patient satisfaction was graded at 1 (treatment met my expectations) in 81.0% of patients who had super majority review favoring fusion as compared to 72.3% of other cases (P=0.20). ODI and EQ-5D outcomes for patients treated with decompression alone versus decompression and fusion were not different at 1 years; ODI (20.09-point change vs 22.94 -point change, respectively [p=0.161]) and EQ-5D (0.235 change vs 0.255 change, respectively [p=0.478]). Complication rates were similar for decompression vs decompression with fusion as well (11.4% vs 14.4% [p=0.533].
Expert panel review does not reduce the number of fusion operations performed but fusion cases where a super majority expert panel favored fusion was associated with fewer failures in health-related quality of life.
This abstract does not discuss or include any applicable devices or drugs.