BACKGROUND: In Scandinavia, spinal fusion is frequently performed without instrumentation, as use of instrumentation in the elderly can be complicated by poor bone quality and the risk of screw pull-out. However, uninstrumented fusion carries the risk of nonunion. We performed a randomized controlled trial in an attempt to determine if use of instrumentation leads to better outcomes and fusion rates when spinal fusion is performed for degenerative spondylolisthesis in the elderly.
METHODS: This was a randomized, single-center, open-label trial of patients with symptomatic single-level degenerative spondylolisthesis who were assigned 1:1 to decompression and fusion with or without instrumentation after at least 12 weeks of nonoperative treatment had failed. The primary outcome was the change in the Oswestry Disability Index (ODI), and secondary outcomes included fusion rates within 1 year, reoperation rates within 2 years, and changes in the EuroQol-5 Dimension-3 Level (EQ-5D) score.
RESULTS: Fifty-four subjects were randomized to each of the 2 groups, which had similar preoperative demographic and surgical characteristics. We found similar improvements in the ODI (p = 0.791), back pain, leg pain, and quality of life between groups at 1 and 2 years of follow-up. Solid fusion on computed tomography (CT) scans was noted in 94% of the patients in the instrumented group and 31% in the uninstrumented group (p < 0.001). One patient (2%) in the instrumented group and 7 (13%) in the uninstrumented group (p = 0.031) had a reoperation within 2 years after the index surgery.
CONCLUSIONS: We found no difference in patient-reported outcomes when we compared instrumented with uninstrumented fusion in patients with degenerative spondylolisthesis. The uninstrumented group had a significantly higher rate of nonunion and reoperations at 2 years.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Bibliographical noteCopyright © 2023 by The Journal of Bone and Joint Surgery, Incorporated.
- Back Pain
- Lumbar Vertebrae/surgery
- Quality of Life
- Spinal Fusion/methods
- Spondylolisthesis/diagnostic imaging
- Treatment Outcome