创伤胫骨锁定钢板的设计及临床应用

Design and clinical application of traumatic tibial locking plate

目的设计研发一种有效固定Pilon骨折的创伤胫骨锁定钢板,并与普通锁定钢板比较评价其疗效。方法选取滨州医学院附属医院2016年1月至2023年1月收治的49例Pilon骨折患者行回顾性分析,根据是否使用创伤胫骨锁定钢板分为试验组(创伤胫骨锁定钢板)28例和对照组(普通锁定钢板)21例。其中试验组男19例,女9例,年龄(39.64±9.11)岁。对照组男14例,女7例,年龄(39.86±9.65)岁。记录并比较两组患者的手术时间、术中出血量、术后并发症发生率等指标,采用Burwell-Charnley影像学评估标准评价术后患者骨折复位及愈合情况,采用美国足踝外科协会(AOFAS)踝-后足评分系统对患者术后3、6个月以及末次随访踝关节的恢复情况进行评价。统计学方法采用t检验和χ^(2)检验。结果两组患者均顺利完成手术,并且都得到完整术后随访,随访时间11~16(13.27±1.44)个月。试验组的手术时间短于对照组[(92.82±8.05)min比(115.67±14.46)min],早期负重时间短于对照组[(7.21±0.92)周比(9.38±1.36)周],Burwell-Charnley影像学优良率高于对照组[100.0%(28/28)比76.2%(16/21)],末次随访AOFAS踝关节评分高于对照组[(91.86±1.51)分比(90.43±1.91)分],术后并发症总发生率低于对照组[3.6%(1/28)比23.8%(5/21)],差异均有统计学意义(t=-7.046、P<0.001,t=-6.662、P<0.001,χ^(2)=7.504、P=0.023,t=2.925、P=0.005,χ^(2)=4.574、P=0.032)。两组术中出血量比较,差异无统计学意义(P>0.05)。结论创伤胫骨锁定钢板具有解剖贴合度高并发症少等优点,可以促使患者提前进行功能锻炼,在治疗Pilon骨折方面较普通锁定钢板具有显著优势。

Objective To design and develop a new locking steel plate that can effectively fix Pilon fracture,and to evaluate its efficacy compared with ordinary locking steel plate.Methods A retrospective analysis was performed on 49 patients with Pilon fracture admitted to Binzhou Medical University Hospital from January 2016 to January 2023,and they were divided into an experimental group(new locking plate,28 cases)and a control group(ordinary locking plate,21 cases)according to whether the new locking plate was used or not.In the experimental group,there were 19 males and 9 females,aged(39.64±9.11)years.In the control group,there were 14 males and 7 females,aged(39.86±9.65)years.The operation time,intraoperative blood loss,and incidence of postoperative complications were recorded and compared between the two groups.The postoperative fracture reduction and healing were evaluated by Burwell-Charnley imaging evaluation criteria,and the ankle recovery was assessed using the Amerian Orthopaedic Foot Ankle Society(AOFAS)ankle-posterior foot score 3 and 6 months after surgery and at the last follow-up.t test andχ^(2)test were used for statistical analysis.Results All patients in both groups successfully completed the operation and received complete postoperative follow-up for 11 to 16(13.27±1.44)months.The operation time of the experimental group was shorter than that of the control group[(92.82±8.05)min vs.(115.67±14.46)min],the early weight-bearing time was shorter than that of the control group[(7.21±0.92)weeks vs.(9.38±1.36)weeks],the excellence rate of Burwell-Charnley imaging was higher than that of the control group[100.0%(28/28)vs.76.2%(16/21)],and the AOFAS ankle score at the last follow-up was higher than that of the control group[(91.86±1.51)points vs.(90.43±1.91)points],and the incidence of postoperative complications was lower than that of the control group[3.6%(1/28)vs.23.8%(5/21)],with statistically significant differences(t=-7.046,P<0.001;t=-6.662,P<0.001;χ^(2)=7.504,P=0.023;t=2.925,P=0.005;χ^(2)=4.574,P=0.032).There were no statistically significant differences in the intraoperative blood loss and fracture healing time between the two groups(both P>0.05).Conclusion The new locking plate has the advantages of high anatomical fit,strong ability to capture fracture fragments,and fewer complications,which can allow patients to perform functional exercises in advance,and has significant advantages over ordinary locking steel plate in the treatment of Pilon fracture.