A prospective, randomized, controlled, multicenter clinical study.
To compare the safety and clinical and radiographic outcomes of OP-1 (BMP-7) Putty to autogenous iliac crest bone graft in a population of patients undergoing laminectomy and posterolateral fusion for symptomatic lumbar stenosis associated with degenerative spondylolisthesis.
Summary of Background Data.
Although the existing preclinical and clinical data suggest that OP-1 is able to achieve osteoinduction and clinical fusion in a variety of situations, the efficacy of this recombinant protein in a clinical spine fusion population has not been fully elucidated. This study directly compares the efficacy and safety of OP-1 putty to autograft bone for arthrodesis in patients with symptomatic stenosis in association with degenerative spondylolisthesis.
Thirty-six patients with degenerative lumbar spondylolisthesis and symptoms of neurogenic claudication underwent laminectomy, bilateral medial facetectomy, and posterolateral fusion using either iliac crest autograft or OP-1 Putty. Oswestry scores and SF-36 questionnaires were used to determine the clinical response to treatment. Independent, blinded neuroradiologists reviewed both static and dynamic radiographs to determine the fusion status. Successful fusion was declared whenthe presence of continuous bridging bone between the transverse processes was observed and less than 5° of angular motion and 2 mm of translational movement was measured using digital calipers.
Efficacy data were tabulated for 27 patients at the 24-month time point and an additional 4 patients (without evaluable 24-month results) at the 36-month time point. One patient was not evaluable for radiology, so the data reflect clinical information for 31 patients and radiology for 30 patients. Clinical success, defined as a 20% improvement in the preoperative Oswestry score, was achieved by 17 of 20 (85%) OP-1 Putty patients and 7 of 11 (64%) autograft patients. A successful posterolateral fusion was achieved in 11 of 20 (55%) OP-1 Putty patients and 4 of 10 (40%) autograft patients. SF-36 scores showed similar clinical improvement in both groups. No systemic toxicity, ectopic bone formation, recurrent stenosis, or other adverse events specifically related to the use of the OP-1 Putty implant were observed.
This study represents the first clinical trial to demonstrate the safety and similarity of OP-1 Putty as a replacement for autogenous bone graft in the posterolateral fusion environment with a minimum of 2-year follow-up. OP-1 Putty was able to achieve osteoinduction leading to a radiographically solid fusion in the absence of autogenous iliac crest bone graft in 55% of the patients at 24 and 36 months. These results compare favorably to the historical fusion rates reported for uninstrumented arthrodesis in this challenging clinical scenario.