TRAUMA
Bone Morphogenetic Protein for the Healing of Tibial Fracture: A Meta-Analysis of Randomized Controlled Trials
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(3):18 PLoS One. 2015 Oct 28;10(10):e0141670.8 RCTs (1113 patients) comparing the use of bone morphogenetic proteins (BMPs) to conventional treatment methods for acute tibial fractures or tibial non-unions were included in this meta-analysis. The purpose of the study was to determine if BMPs improved the rate of union or decreased surgical revision rate compared to various standard practices. BMPs were found to significantly increase union rates and decrease revision rates when used for the treatment of acute tibial fractures but provided no additional benefit to treatment of tibial non-unions. The use of BMPs had no significant influence on the rate of infection for either type of injury when compared to standard care practices. It should be noted that majority of studies included in the acute fracture analyses only evaluated BMPs in open fractures and that both analyses for acute and non-union fractures were limited by the number of available randomized controlled trials.
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
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はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
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Introduction
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Accessing Data
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Analysing Data
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Results
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Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Tibial fractures most commonly result from high-energy trauma and are associated with high rates of delayed union and nonunion. Conventional treatment methods, including intramedullary nailing or locking plate fixation, have previously been combined with biological substances, such as bone morphogenetic proteins (BMPs), in order to accelerate healing and decrease disability. BMPs play a role in bone formation/repair and have been found to hasten bone union and decrease revision rates in previous studies. While prior meta-analyses evaluating the efficacy of BMPs for tibial fracture healing have been conducted, they were limited by the quality and quantity of existing studies. The current meta-analysis was needed to combine large, high-quality randomized trials to overcome the limitations of previous reviews.
主な研究課題は何ですか？
Does the use of bone morphogenetic protein (BMP) in the treatment of tibial fractures improve the rate of union/revision when compared to the use of standard care in both acute and non-union fractures?
重要な知見は？
- 4 RCTs (868 patients) involved patients with acute tibial fractures (3 studies included open fractures/ 1 study included both open and closed fractures). 4 RCTs (245 patients) involved patients with tibial fracture non-union.
- In acute tibial fracture patients, rate of bone union was significantly higher in the BMP group (65%) compared to standard care alone (58.8%) (4 studies [868 patients], RR=1.16 [95% CI 1.04 to 1.30]; I2=14%).
- In acute tibial fracture patients, rate of revision surgery was significantly lower in the BMP group (23%) compared to standard care alone (29.4%) (5 studies [853 patients], RR=0.68 [95% CI 0.54 to 0.85]; I2= 5%).
- In acute tibial fracture patients, rate of hardware failure was not significantly different (4 studies [744 patients], RR=0.77 [95% CI 0.50 to 1.18]; I2=32%), and there were no differences in infection rate between groups (4 studies [744 patients], RR= 1.07 [95% CI 0.66 to 1.74]; I2=54%).
- In tibial non-union patients, rate of bone union was similar between treatment groups (4 studies [245 patients], RR=0.98 [95% CI 0.86 to 1.13]; I2=53%).
- In tibial non-union patients, rate of surgical revision was lower in the BMP group compared to standard care alone but the difference was not significant (1 study [124 patients], RR=0.48 [95% CI 0.13 to 1.85]; I2=NA).
- In tibial nonunion patients, infection rate was lower in the BMP group compared to standard care alone but not significantly different (2 studies [154 patients], RR= 0.61 [95% CI 0.37 to 1.02]; I2=0%).
最も覚えておくべきことは？
When used to treat acute tibial fractures, bone morphogenetic proteins were found to significantly improve union rate and reduce surgical revision rate compared to standard practice alone. It should be noted that the majority of patient included in this analyses came from studies only investigating open fractures, so findings may not be representative of a closed fracture population. Results from analyses investigating treatment of tibial non-unions found no significant effects between groups. Additionally, bone morphogenetic proteins had no significant influence on infection rate for either type of injury.
それが私の患者ケアにどのように影響するか？
The findings from this study suggest the use bone morphogenetic proteins (BMP) may be beneficial for the treatment of acute tibial fractures, improving union rate and reducing the need for surgical revision. However, these finding may only be applicable to open fractures. The use of bone morphogenetic proteins in the treatment of tibial non-unions suggests that they may not provide any additional benefit over standard care. While this study presents supportive evidence for the benefits of BMP in the treatment of tibial fractures, results should be interpreted with caution due to the low number of studies included and the assumed high heterogeneity as a result of the low statistical power. Therefore, additional high-quality studies utilizing larger sample sizes and longer follow-up times should be undertaken to further verify the efficacy of this treatment practice.
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