小切口切开复位联合可吸收螺钉内固定修复前交叉韧带胫骨止点撕脱骨折的有效及安全性:自身对照临床试验方案及预试验结果  

Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial protocol and pilot study results

作　　者：杨小广 王映珍[2] Yang Xiaoguang;Wang Yingzhen(Third Department of Orthopedics, No. 1 Hospital of Longnan City, Longnan 746000, Gansu Province, China;Department of Orthopedics, Second Clinical Medical College of Lanzhou University, Lanzhou 730000, Gansu Province, China)

机构地区：[1]甘肃省陇南市第一人民医院骨三科,甘肃省陇南市746000 [2]兰州大学第二临床医学院骨科,甘肃省兰州市730000

出　　处：《中国组织工程研究》2019年第24期3819-3823,共5页Chinese Journal of Tissue Engineering Research

摘　　要：背景:前临床上主张对前交叉韧带胫骨止点撕脱骨折患者早期切开复位,同时根据骨块的大小选择最佳的固定方式能够有效促进交叉韧带恢复正常解剖位置,达到骨性的愈合。有研究表明,采用可吸收螺钉进行内固定治疗前交叉韧带胫骨止点撕脱骨折,能有效促进术后骨折愈合,但疗效及安全性尚需进一步探讨。目的:试验旨在观察小切口切开复位可吸收螺钉内固定修复前交叉韧带胫骨止点撕脱骨折的效果及安全性。方法:此项前瞻性、单中心、自身对照研究纳入中国甘肃省陇南市第一人民医院的前交叉韧带胫骨止点撕脱骨折患者72例,采用小切口切开复位联合可吸收螺钉内固定修复,随3,6,12个月。试验经陇南市第一人民医院医学伦理委员会批准(伦审第S2014-064-02号),方案版本号1.0。参与试验的患者及其家属在充分了解治疗方案的前提下签署"知情同意书"。试验方案已在中国临床试验注册中心注册(注册号:ChiCTR1900021865),注册时间:2019-03-13。结果与结论:试验的主要结局指标为以术后12个月Lysholm膝关节评分评估膝关节功能恢复情况。次要结局指标为术前、术后3,6个月Lysholm膝关节评分,术前、术后3,6,12个月国际膝关节评分委员会评分、膝关节平均活动度、膝关节X射线和MRI形态,术后3,6,12个月不良反应发生率。课题组前期(2015年10月到2018年1月)收集了50例(50膝)前交叉韧带胫骨止点撕脱骨折患者的临床小样本资料,随访6个月的试验结果发现:①术后3个月X射线复查患者骨折均愈合情况均未发现关节僵硬和骨折再移位等现象;②术后6个月患者膝关节平均活动度明显高于术前(P <0.05);③术后6个月患者Lysholm膝关节评分及国际膝关节评分委员会评分均明显比术前有所改善(P <0.05)。因此,作者旨在观察和评价小切口切开复位并可吸收螺钉内固定修复前交叉韧带胫骨止点撕脱BACKGROUND: Anterior cruciate ligament tibial eminence avulsion fractures are repaired via early open reduction. Choosing the best fixation method in accordance with the bone size can effectively promote restoration of the cruciate ligament to its normal anatomical position and achieve bone healing. The use of absorbable screws for internal fixation of anterior cruciate ligament tibial eminence avulsion fractures reportedly promotes fracture healing, but the efficacy and safety need further clarification. OBJECTIVE: The present study aims to observe the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture. METHODS: This prospective, single-center, self-controlled trial will include 72 patients with anterior cruciate ligament tibial eminence avulsion fractures. Open reduction and internal fixation with absorbable screws will be performed through a small incision. All patients will be followed up at 3, 6, and 12 months postoperatively. This study was approved by the Medical Ethics Committee of No. 1 Hospital of Longnan City, China in December 2014 (approval number: S2014-064-02). Protocol version is (1.0). Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants’ family members or the participants themselves. This study was registered with the Chinese Clinical Trial Registry on March 13, 2019 (registration number: ChiCTR1900021865). RESULTS AND CONCLUSION: The primary outcome measure is the recovery of knee function assessed by the Lysholm Knee Scoring Scale score at 12 months postoperatively. Secondary outcome measures are the Lysholm Knee Scoring Scale scores preoperatively and 3 and 6 months postoperatively, the International Knee Documentation Committee scores, knee range of motion, knee morphology on radiographs and MR images preoperatively and 3, 6, and 12 months postoperatively, and the incidences of adverse reactions

关 键 词：前交叉韧带胫骨止点撕脱骨折 切开复位 可吸收螺钉 内固定 Lysholm膝关节评分 国际膝关节评分委员会评分 自身对照研究 

分 类 号：R459.9[医药卫生—治疗学] R605[医药卫生—临床医学]