Safety and Reoperation Rates in Non-instrumented Lumbar Fusion Surgery: Secondary Report From a Randomized Controlled Trial of ABM/P-15 vs Allograft With Minimum 5 years Follow-Up
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Study Design: Randomized controlled trial with minimum of 5-years follow-up. Objective: The purpose of this study is to evaluate the peri- and postoperative complications rates, ectopic bone migration, and reoperation rates, and secondly evaluate the 5-year patient reported outcomes (PROs), in patients treated with decompression and non-instrumented posterolateral fusion with ABM/P-15 or allograft. Methods: Patients with degenerative spondylolisthesis were enrolled in a Randomized Clinical Trial and randomized 1:1 to either ABM/P-15 or allograft bone. Patient Reported Outcomes were collected at 5-year follow-up, and patients were invited to a clinical follow-up including a computed tomography scan (CT) to evaluate signs of osteolysis, ectopic bone formation, and bone migration. Results: Of 101 subjects enrolled in the primary study, 83 patients were available for the 5-year follow-up. We found a statistically significant difference in back pain and Oswestry Disability Index between groups. Fifty-eight patients agreed to participate in the CT study. Sixty percentage in the ABM/P-15 group vs 30% in the allograft group was classified as fused (P =.037). There were no differences in complications, reoperation-, or infection rates between the 2 groups. We found 2 patients with migration of graft material. Both patients were asymptomatic at minimum 5-year follow-up. Conclusion: Our study indicated that complication rates are no higher in patients treated with ABM/P-15 than allograft. We found significantly higher fusion rates in the AMB/P-15 group than in the allograft group, and patients in the ABM/P-15 group reported less back pain and lower disability score at 5-year follow-up.
Originalsprog | Engelsk |
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Tidsskrift | Global Spine Journal |
Vol/bind | 14 |
Udgave nummer | 1 |
Sider (fra-til) | 33-40 |
Antal sider | 8 |
ISSN | 2192-5682 |
DOI | |
Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The institution has recieved a research grant from Cerapedics, USA.
Publisher Copyright:
© The Author(s) 2022.
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