Recombinant human bone morphogenetic protein-2 in open tibial fractures - A subgroup analysis of data combined from two prospective randomized studies
Recombinant human bone morphogenetic protein-2 in open tibial fractures - A subgroup analysis of data combined from two prospective randomized studies
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DOI：
10.2106/jbjs.e.00499
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发表时间：
2006-06-01
影响因子：
5.3
通讯作者：
Patel, Amratlal
中科院分区：
文献类型：
--
作者：
Swiontkowski, Marc F.;Aro, Hannu T.;Patel, Amratlal
背景资料：使用重组人骨形态发生蛋白-2（rhBMP-2）来促进开放性胫骨干骨折的愈合一直是两项前瞻性临床研究的焦点。本研究的目的是进行一个亚组分析的组合数据从这些study.Methods：两个前瞻性，随机临床研究进行。共有510例开放性胫骨骨折患者随机接受对照治疗（髓内钉固定和常规软组织管理）或对照治疗和浸有两种浓度rhBMP-2之一的可吸收胶原海绵。在最终伤口闭合时，将rhBMP-2植入物置于骨折处。出于本分析的目的，仅比较了对照处理和美国食品药品监督管理局批准的rhBMP-2浓度（1.50 mg/mL）。预期接受计划的骨移植作为分期治疗的一部分的患者被排除在enrollment.Results：五十九创伤中心在12个国家参加，并随访患者术后12个月。分析了两个亚组：（1）131例Gustilo-Anderson IIIA型或11113开放性胫骨骨折患者，（2）113例接受扩髓髓内钉治疗的患者。与对照组相比，第一个亚组显示rhBMP-2组有显著改善，骨移植手术较少（p = 0.0005），需要侵入性二次干预的患者较少（p = 0.0065），感染率较低（p = 0.0234）。扩髓髓内钉治疗骨折的第二个亚组分析表明，对照组和rhBMP-2 groups.Conclusions之间没有显着差异：除了rhBMP-2治疗III型开放性胫骨骨折可以显着减少植骨手术和其他二次干预的频率。该分析确定了rhBMP-2联合可吸收胶原海绵植入物治疗这些严重骨折的临床疗效。
Background: The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) to improve the healing of open tibial shaft fractures has been the focus of two prospective clinical studies. The objective of the current study was to perform a subgroup analysis of the combined data from these studies.Methods: Two prospective, randomized clinical studies were conducted. A total of 510 patients with open tibial fractures were randomized to receive the control treatment (intramedullary nail fixation and routine soft-tissue management) or the control treatment and an absorbable collagen sponge impregnated with one of two concentrations of rhBMP-2. The rhBMP-2 implant was placed over the fracture at the time of definitive wound closure. For the purpose of this analysis, only the control treatment and the Food and Drug Administration-approved concentration of rhBMP-2 (1.50 mg/mL) were compared. Patients who anticipated receiving planned bone-grafting as part of a staged treatment were excluded from enrollment.Results: Fifty-nine trauma centers in twelve countries participated, and patients were followed for twelve months postoperatively. Two subgroups were analyzed: (1) the 131 patients with a Gustilo-Anderson type-IIIA or 11113 open tibial fracture and (2) the 113 patients treated with reamed intramedullary nailing. The first subgroup demonstrated significant improvements in the rhBMP-2 group, with fewer bone-grafting procedures (p = 0.0005), fewer patients requiring invasive secondary interventions (p = 0.0065), and a lower rate of infection (p = 0.0234), compared with the control group. The second subgroup analysis of fractures treated with reamed intramedullary nailing demonstrated no significant difference between the control and the rhBMP-2 groups.Conclusions: The addition of rhBMP-2 to the treatment of type-III open tibial fractures can significantly reduce the frequency of bone-grafting procedures and other secondary interventions. This analysis establishes the clinical efficacy of rhBMP-2 combined with an absorbable collagen sponge implant for the treatment of these severe fractures.