Hernigou P, Dubory A, Pariat J, Potage D, Roubineau F, Jammal S, Flouzat Lachaniette C H
Department of Orthopaedic Surgery, University Paris East (UPEC), hôpital Henri-Mondor, avenue du Maréchal-de-Lattre-de-Tassigny, 94010 Créteil, France.
Department of Orthopaedic Surgery, University Paris East (UPEC), hôpital Henri-Mondor, avenue du Maréchal-de-Lattre-de-Tassigny, 94010 Créteil, France.
Morphologie. 2017 Sep;101(334):173-179. doi: 10.1016/j.morpho.2017.03.005. Epub 2017 May 10.
Autogenous bone graft (autograft) remains the gold standard in the treatment of many orthopedic problems. However, graft harvest can lead to perioperative morbidity and increased cost. We tested the hypothesis that an osteoconductive matrix, beta-tricalcium phosphate (β-TCP), would be a safe and effective alternative to autograft alone. Beta-tricalcium phosphate (β-TCP) is considered as one of the most promising biomaterials for bone reconstruction. This study analyzes the outcomes of patients who received β-TCP as bone substitutes in orthopedic surgery.
A total of 50 patients were enrolled in a controlled, non-inferiority clinical trial to compare the safety and efficacy of β-TCP (25 patients) with those of autograft (25 patients) in indications requiring usually autograft. These 50 patients were categorized according to the etiology and morphology of the 54 bone defects resulting from elective surgical procedures, such as 34 open-wedge high tibial osteotomies, and 20 osteonecrosis treatments with core decompression. Radiographic (healing process with or without integration of β-TCP), clinical (no other surgical procedure), functional outcomes and safety (with or without complications) were assessed through fifty-two weeks postoperatively.
With regard to the primary endpoint (radiographic evolution), the fusion rate of the 34 open-wedge osteotomies was 100% (17 among 17) for patients in the group with β-TCP compared with 94% (16 among 17) for patients in the autograft group. For the 20 cavitary defects (osteonecrosis), the radiographic union rates, as determined by the presence of osseous bridging, were 100% for patients in the group with β-TCP and 100% for those in the autograft group. Clinically at one year, all quality-of-life and functional outcome data supported non-inferiority of β-TCP compared with autograft, and patients in the β-TCP group were found to have less pain and an improved safety profile.
Treatment with β-TCP resulted in comparable fusion rates, less pain and fewer side effects as compared with treatment with autograft. This study established clinical parameters where the β-TCP alone can successfully support the osteogenic process.
自体骨移植（自体骨）仍是治疗许多骨科问题的金标准。然而，取骨可能导致围手术期发病和成本增加。我们检验了以下假设：一种骨传导基质，即β-磷酸三钙（β-TCP），将是单独使用自体骨的一种安全有效的替代方法。β-磷酸三钙（β-TCP）被认为是用于骨重建最有前景的生物材料之一。本研究分析了在骨科手术中接受β-TCP作为骨替代物的患者的治疗结果。
总共50名患者参加了一项对照、非劣效性临床试验，以比较β-TCP组（25名患者）和自体骨组（25名患者）在通常需要自体骨的适应症中的安全性和有效性。这50名患者根据择期手术导致的54处骨缺损的病因和形态进行分类，例如34例开放性楔形高位胫骨截骨术和20例采用髓芯减压的骨坏死治疗。通过术后52周评估影像学（β-TCP融合或未融合的愈合过程）、临床（无其他手术）、功能结果和安全性（有无并发症）。
关于主要终点（影像学进展），β-TCP组患者的34例开放性楔形截骨术融合率为100%（17例中的17例），而自体骨组患者为94%（17例中的16例）。对于20处空洞性缺损（骨坏死），根据骨桥形成确定的影像学愈合率，β-TCP组患者为100%，自体骨组患者也为100%。在临床一年时，所有生活质量和功能结果数据均支持β-TCP与自体骨相比的非劣效性，并且发现β-TCP组患者疼痛较轻且安全性更好。
与自体骨治疗相比，β-TCP治疗导致了相当的融合率、更少的疼痛和更少的副作用。本研究确立了单独使用β-TCP可成功支持成骨过程的临床参数。
