PDLLA可吸收螺钉和金属螺钉治疗下胫腓联合分离的前瞻性对照研究

A prospective randomized trial of poly-DL-lactic acid absorbable and metallic screws for treatment of syndesmotic disruptions

目的通过前瞻性随机对照研究比较及评价聚-DL-乳酸(PDLLA)可吸收螺钉和钛合金金属螺钉治疗踝关节骨折中下胫腓联合损伤分离的临床疗效。方法对2005年4月～2008年6月58例伴有下胫腓联合损伤分离或可疑下胫腓联合损伤分离的闭合性踝关节骨折病例纳入本项研究,术前随机将患者分为两组,根据术前X线测量和术中牵拉实验最终确诊47例下胫腓联合分离患者,应用PDLLA可吸收螺钉治疗22例,金属螺钉治疗25例,金属螺钉在术后10～12周取出。在术后6个月,对手术侧踝关节的AOFAS踝关节功能评分、踝关节活动度、X线正位片TFCS和TFO宽度和异物反应发生进行比较。结果两组均获得满意疗效,两组间踝关节功能评分,踝关节活动度和X线片测量均无统计学差异(P>0.05)。结论 PDLLA可吸收螺钉治疗下胫腓联合损伤分离效果可靠有效,并且免除二次手术取钉,有广泛临床应用价值。

Objective To compare the clinical effect of poly-DL-lactic acid（PDLLA） absorbable screws and titanium metallic screws in the treatment of syndesmotic disruptions in ankle fractures.Methods In this prospective,randomized clinical trial,58 patients with or suspected of syndesmotic disruption associated with ankle fractures were randomly allocated to receive eitherbioabsorbable PDLLA ormetallic titanium screwing fixation.Using preoperative radiography and intraoperative hook test,syndesmotic disruption was confirmed in 47 cases（25 with metallic screwing and 22 with PLLA screwing）.Statistical analyses were performed at 6 months postoperatively to compare the AOFAS score,range of motion of the joint,TFCS width and TFO width on anteroposterior view radiographs,and inflammatory reactions between the two groups.Results The PDLLA screws showed good therapeutic effect similar to that of titanium metallic screws in syndesmosis fixation in these patients.No significant differences were found in the AOFAS score,range of motion of the joint,orTFCS width orTFO width between two groups（P0.05）.One patient in PDLLA screw group showed inflammatory reactions to the implants.Conclusion PDLLA screws allow effective and reliable stabilization of syndesmotic disruptions without a second operation forscrew removal.