The results demonstrate that OP-1 combined with locally obtained autograft is a safe and effective alternative for iliac crest autograft in instrumented single-level posterolateral fusions of the lumbar spine. The main advantage of OP-1 is that it avoids morbidity associated with the harvesting of autogenous bone grafts from the iliac crest.

BackgroundIn instrumented posterolateral fusion reduction of a spondylolisthesis is appealing on theoretical grounds since this may lead to indirect decompression of the entrapped nerve roots. However, there is no consensus in the literature whether a beneficial effect of reduction on outcome can be expected. The objective of the current study was to evaluate whether a correlation between the extent of listhesis reduction and clinical improvement could be established.MethodsFrom two ongoing prospective studies 72 patients with a single-level instrumented posterolateral lumbar fusion for low-grade spondylolisthesis (isthmic/degenerative 51/21) were evaluated. Radiographs and clinical outcome scores were available at baseline, 6 weeks and 1 year after surgery. Changes in neuroforaminal morphology were measured on calibrated radiographs. These changes in radiographic parameters were correlated to clinical outcome (Visual Analogue Score (VAS) leg pain, Oswestry Disability Index (ODI)). Fusion status was assessed on Computed Tomography-scan at one year.ResultsA mean spondylolisthesis of 25 percent was reduced to 15 percent at 6 weeks with some loss of reduction to 17 percent at one year. The VAS and ODI significantly improved at both time intervals after surgery (p < 0.001). No significant correlations could be established between the extent of slip reduction and improvement in VAS or ODI (Pearson’s correlation −0.2 and 0.07 respectively at one year); this also accounted for the other radiographic parameters. A fusion rate of 64 percent was seen on CT-scan.ConclusionsClinical outcome was not related to the obtained radiographic reduction of the slipped vertebra in patients with a lumbar fusion for low grade spondylolisthesis. Loss of reduction or non-union on CT-scans had no effect on the clinical outcome. Reduction of a low-grade spondylolisthesis in spinal fusion is appealing, however, there is no evidence that it positively affects clinical outcome on the short term.Trial registrationISRCTN43648350

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Purpose Despite the rapid increase in instrumented spinal fusions for a variety of indications, most studies focus on short-term fusion rates. Long-term clinical outcomes are still scarce and inconclusive. This study investigated clinical outcomes > 10 years after single-level instrumented posterolateral spinal fusion for lumbar degenerative or isthmic spondylolisthesis with neurological symptoms. Methods Cross-sectional long-term follow-up among the Dutch participants of an international multicenter randomized controlled trial comparing osteogenic protein-1 with autograft. Clinical outcomes were assessed using the Oswestry Disability Index (ODI), EQ-5D-3L and visual analogue scale (VAS) for leg and back pain, as well as questions on satisfaction with treatment and additional surgery. Results The follow-up rate was 73% (41 patients). At mean 11.8 (range 10.1–13.7) years after surgery, a non-significant deterioration of clinical outcomes compared to 1-year follow-up was observed. The mean ODI was 20 ± 19, mean EQ-5D-3L index score 0.784 ± 0.251 and mean VAS for leg and back pain, respectively, 34 ± 33 and 31 ± 28. Multiple regression showed that diagnosis (degenerative vs. isthmic spondylolisthesis), graft type (OP-1 vs. autograft) and 1-year fusion status (fusion vs. no fusion) were not predictive for the ODI at long-term follow-up (p = 0.389). Satisfaction with treatment was excellent and over 70% of the patients reported lasting improvement in back and/or leg pain. No revision surgeries for non-union were reported. Conclusion This study showed favourable clinical outcomes > 10 years after instrumented posterolateral spinal fusion and supports spondylolisthesis with neurological symptoms as indication for fusion surgery.

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