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首页> 外文期刊>The Journal of Bone and Joint Surgery. American Volume >Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial.
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Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial.

机译：重组人BMP-2和同种异体骨移植与自体骨移植相比，可重建具有皮质缺损的干phy端胫骨骨折。一项随机对照试验。

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BACKGROUND: Currently, the treatment of diaphyseal tibial fractures associated with substantial bone loss often involves autogenous bone-grafting as part of a staged reconstruction. Although this technique results in high healing rates, the donor-site morbidity and potentially limited supply of suitable autogenous bone in some patients are commonly recognized drawbacks. The purpose of the present study was to investigate the benefit and safety of the osteoinductive protein recombinant human bone morphogenetic protein-2 (rhBMP-2) when implanted on an absorbable collagen sponge in combination with freeze-dried cancellous allograft. METHODS: Adult patients with a tibial diaphyseal fracture and a residual cortical defect were randomly assigned to receive either autogenous bone graft or allograft (cancellous bone chips) for staged reconstruction of the tibial defect. Patients in the allograft group also received an onlay application of rhBMP-2 on an absorbable collagen sponge. The clinical evaluation of fracture-healing included an assessment of pain with full weight-bearing and fracture-site tenderness. The Short Musculoskeletal Function Assessment (SMFA) was administered before and after treatment. Radiographs were used to document union, the presence of extracortical bridging callus, and incorporation of the bone-graft material. RESULTS: Fifteen patients were enrolled in each group. The mean length of the defect was 4 cm (range, 1 to 7 cm). Ten patients in the autograft group and thirteen patients in the rhBMP-2/allograft group had healing without further intervention. The mean estimated blood loss was significantly less in the rhBMP-2/allograft group. Improvement in the SMFA scores was comparable between the groups. No patient in the rhBMP-2/allograft group had development of antibodies to BMP-2; one patient had development of transient antibodies to bovine type-I collagen. CONCLUSIONS: The present study suggests that rhBMP-2/allograft is safe and as effective as traditional autogenous bone-grafting for the treatment of tibial fractures associated with extensive traumatic diaphyseal bone loss. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.
机译：背景：目前，与实质性骨丢失有关的干dia胫骨骨折的治疗通常涉及自体骨移植，作为分阶段重建的一部分。尽管此技术可导致较高的治愈率，但公认的缺点是供体部位的发病率以及某些患者中合适的自体骨的潜在供应有限。本研究的目的是研究与冷冻干燥的同种异体移植物一起植入可吸收的胶原海绵中时，骨诱导蛋白重组人骨形态发生蛋白2（rhBMP-2）的益处和安全性。方法：将具有胫骨干phy端骨折并残留皮质缺损的成人患者随机分配为接受自体骨移植或同种异体移植（松质骨碎屑）以分阶段重建胫骨缺损。同种异体移植组的患者还接受了在可吸收胶原海绵上的rhBMP-2覆盖应用。骨折愈合的临床评估包括对完全负重和骨折部位压痛的疼痛的评估。在治疗前后进行了短肌骨骼功能评估（SMFA）。射线照相用于记录结合，皮质外桥接愈伤组织的存在以及骨移植材料的结合。结果：每组有15名患者入组。缺损的平均长度为4厘米（范围为1至7厘米）。自体移植组的10例患者和rhBMP-2 /同种异体移植组的13例患者无需进一步干预即可治愈。 rhBMP-2 /同种异体移植组的平均估计失血量明显减少。两组之间SMFA分数的提高相当。 rhBMP-2 /同种异体移植组中没有患者出现针对BMP-2的抗体。一名患者出现了针对牛I型胶原的瞬时抗体。结论：目前的研究表明，rhBMP-2 /同种异体移植物与传统的自体骨移植物治疗与广泛性外伤性干phy端骨质流失相关的胫骨骨折一样安全且有效。证据级别：治疗级别II。有关证据水平的完整说明，请参见《作者须知》。

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