Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study.
Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study.
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DOI：
10.1186/1475-925x-12-62
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发表时间：
2013-07-03
影响因子：
3.9
通讯作者：
Waizy H
中科院分区：
文献类型：
--
作者：
Windhagen H;Radtke K;Weizbauer A;Diekmann J;Noll Y;Kreimeyer U;Schavan R;Stukenborg-Colsman C;Waizy H
不可降解的钢基和钛基植入物通常用于骨科手术。尽管它们提供了最大的稳定性，但它们也与成像模式的干扰有关，可能会引起应力屏蔽，并且可能需要额外的外植手术。另外，可降解聚合物植入物的机械性能较弱，会引起异物反应。目前正在研究可降解镁基支架在心血管医学中的应用。镁合金MgYREZr表现出良好的生物相容性和骨传导性能。这项前瞻性、随机、临床试点试验的目的是确定镁基 MgYREZr 螺钉是否等同于标准钛螺钉，用于在轻度拇外翻患者进行 V 形截骨术期间进行固定。患者 (n=26) 被随机分配接受使用相同设计的钛或可降解镁基植入物进行骨缝合术。 6 个月的随访期包括临床、实验室和放射学评估。美国骨科足踝协会 (AOFAS) 的拇趾评分、疼痛评估的视觉模拟量表或第一跖趾关节 (MTPJ) 的活动范围 (ROM) 没有发现显着差异。未检测到异物反应、骨质溶解或全身炎症反应。各组在放射学或实验室结果方面没有显着差异。这项前瞻性对照研究的放射学和临床结果表明，可降解镁基螺钉在治疗轻度拇外翻畸形方面与钛螺钉相当。
Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities.