Haubruck Patrick, Tanner Michael C, Vlachopoulos Wasilios, Hagelskamp Saskia, Miska Matthias, Ober Julian, Fischer Christian, Schmidmaier Gerhard
HTRG, Heidelberg Trauma Research Group, Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Trauma and Reconstructive Surgery, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118 Heidelberg, Germany.
HTRG, Heidelberg Trauma Research Group, Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Trauma and Reconstructive Surgery, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118 Heidelberg, Germany.
Orthop Traumatol Surg Res. 2018 Dec;104(8):1241-1248. doi: 10.1016/j.otsr.2018.08.008. Epub 2018 Oct 4.
Substantial evidence exists demonstrating the individual effectiveness of both rhBMP-2 and -7 in the treatment of nonunions, data comparing the clinical effectiveness of adjunct rhBMP-2 and -7 remains scarce. Therefore, we examined our large single-center case series to compare the clinical effectiveness of both rhBMP-2 and -7 in non-union therapy aiming to answer: - Does a certain type of BMP have an advantageous effect on radiological outcome of applied lower limb non-union therapy? - Does application of a certain type of BMP have an advantageous effect on radiological outcome of infected lower limb nonunions? - Are there any additional risk factors associated with inferior outcome in context with an adjunct BMP treatment?
Both BMPs have the same effect on the radiological outcome of surgically treated lower limb nonunions.
Single-center retrospective database analysis of a case series of patients with lower limb long bone nonunions receiving either a one- or two-stage (Masquelet-) procedure based on the "diamond concept" with application of rhBMP-2 or -7. The "diamond concept" summarizes core factors that need to be present to achieve bone healing. In particular, these factors relate to the optimization of the mechanical (stability) and biological environment (sufficient osteogenic and angiogenic cells, osteoconductive scaffolds and growth factors). All medical data from patients that received surgical treatment between 01/01/2010 and 31/12/2016 were assessed. In total, 356 patients were treated with BMPs and 156 patients 18 years or older with non-union of their tibia or femur having a follow-up of at least 1 year were included. Consolidation in context with type of rhBMP was compared and the influence of relevant risk factors assessed.
Consolidation rate was significantly higher in patients treated with rhBMP-2 (rhBMP-2: 42/46 (91%) vs. rhBMP-7: 64/110 (58%); p<0.001). In particular, application of rhBMP-2 increased the likelihood of consolidation for tibial nonunions (OR 32.744; 95%CI: 2.909-368.544; p=0.005) and when used in two-stage therapy (OR 12.095; 95% CI: 2.744-53.314; p=0.001). Furthermore, regression modeling revealed a higher correlation between application of rhBMP-2 and osseous consolidation in infected nonunions (OR 61.062; 95% CI: 2.208-1688.475; p=0.015) than in aseptic nonunions (OR 4.787; 95% CI: 1.321-17.351; p=0.017). Risk factors negatively influencing the outcome of non-union treatment in context with rhBMPs were identified as active smoking (OR 0.357; 95% CI: 0.138-0.927; p=0.024), atrophic nonunion (OR 0.23; 95% CI: 0.061-0.869; p=0.030), higher BMI (OR 0.919; 95% CI: 0.846-0.998; p=0.046) and a larger defect size (OR 0.877; 95% CI: 0.784-0.98; p=0.021).
Patients who received rhBMP-2 for the treatment of tibial nonunions and as part of the two-stage treatment had a significantly higher rate of healing compared to patients treated with rhBMP-7 regardless of infection.
III, retrospective case-control study.
有大量证据表明重组人骨形态发生蛋白-2（rhBMP-2）和重组人骨形态发生蛋白-7（rhBMP-7）在治疗骨不连方面各自具有有效性，但比较辅助使用rhBMP-2和rhBMP-7临床疗效的数据仍然很少。因此，我们研究了我们的大型单中心病例系列，以比较rhBMP-2和rhBMP-7在骨不连治疗中的临床疗效，旨在回答以下问题：- 某种类型的骨形态发生蛋白（BMP）对应用于下肢骨不连治疗的放射学结果是否具有有利影响？- 应用某种类型的BMP对感染性下肢骨不连的放射学结果是否具有有利影响？- 在辅助使用BMP治疗的情况下，是否存在与较差结果相关的任何其他风险因素？
两种BMP对手术治疗的下肢骨不连的放射学结果具有相同的影响。
对接受基于“钻石概念”的一期或二期（Masquelet）手术并应用rhBMP-2或rhBMP-7的下肢长骨骨不连患者的病例系列进行单中心回顾性数据库分析。“钻石概念”总结了实现骨愈合所需存在的核心因素。特别是，这些因素涉及机械（稳定性）和生物环境（足够的成骨细胞和血管生成细胞、骨传导支架和生长因子）的优化。评估了2010年1月1日至2016年12月31日期间接受手术治疗的所有患者的医疗数据。共有356例接受BMP治疗的患者，其中156例18岁及以上胫骨或股骨骨不连且随访至少1年的患者被纳入。比较了与rhBMP类型相关的骨愈合情况，并评估了相关风险因素的影响。
接受rhBMP-2治疗的患者骨愈合率显著更高（rhBMP-2：42/46（91%） vs. rhBMP-7：64/110（58%）；p<0.001）。特别是，应用rhBMP-2增加了胫骨骨不连的骨愈合可能性（比值比（OR）32.744；95%置信区间（CI）：2.909 - 368.544；p = 0.005），并且在二期治疗中使用时（OR 12.095；95% CI：2.744 - 53.314；p = 0.001）。此外，回归模型显示，与无菌性骨不连（OR 4.787；95% CI：1.321 - 17.351；p = 0.017）相比，rhBMP-2应用与感染性骨不连的骨愈合之间的相关性更高（OR 61.062；95% CI：2.208 - 1688.475；p = 0.015）。与rhBMPs相关的对骨不连治疗结果有负面影响的风险因素被确定为主动吸烟（OR 0.357；95% CI：0.138 - 0.927；p = 0.024）、萎缩性骨不连（OR 0.23；95% CI：0.061 - 0.869；p = 0.030）、较高的体重指数（BMI）（OR 0.919；95% CI：0.846 - 0.998；p = 0.046）和较大的缺损尺寸（OR 0.877；95% CI：0.784 - 0.98；p = 0.021）。
无论是否感染，接受rhBMP-2治疗胫骨骨不连以及作为二期治疗一部分的患者的愈合率明显高于接受rhBMP-7治疗的患者。
III级，回顾性病例对照研究。
