Andresen Andreas K, Carreon Leah Y, Overgaard Søren, Jacobsen Michael K, Andersen Mikkel Ø
Center for Spine Surgery and Research, Lillebaelt Hospital, Middelfart, Denmark.
Institute of Regional Health Research, University of Southern Denmark, Odense C, Denmark.
Global Spine J. 2024 Jan;14(1):33-40. doi: 10.1177/21925682221090924. Epub 2022 Apr 28.
Randomized controlled trial with minimum of 5-years follow-up.
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.
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.
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 ( = .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.
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.
至少随访5年的随机对照试验。
本研究的目的是评估减压联合ABM/P - 15或同种异体骨非内固定后外侧融合术患者围手术期及术后并发症发生率、异位骨迁移率和再次手术率，其次评估5年患者报告结局（PROs）。
将退行性腰椎滑脱患者纳入一项随机临床试验，并按1:1随机分为ABM/P - 15组或同种异体骨组。在5年随访时收集患者报告结局，并邀请患者进行临床随访，包括计算机断层扫描（CT）以评估骨溶解、异位骨形成和骨迁移的迹象。
在纳入初步研究的101名受试者中，83名患者可进行5年随访。我们发现两组之间在背痛和Oswestry功能障碍指数方面存在统计学显著差异。58名患者同意参加CT研究。ABM/P - 15组60%的患者与同种异体骨组30%的患者被分类为融合（P = .037）。两组在并发症、再次手术率或感染率方面无差异。我们发现2例移植材料迁移患者。两名患者在至少5年的随访中均无症状。
我们的研究表明，ABM/P - 15治疗的患者并发症发生率并不高于同种异体骨治疗的患者。我们发现ABM/P - 15组的融合率显著高于同种异体骨组，并且ABM/P - 15组的患者在5年随访时报告的背痛较少，残疾评分较低。
