中国组织工程研究

中国组织工程研究 ›› 2019, Vol. 23 ›› Issue (24): 3819-3823.doi: 10.3969/j.issn.2095-4344.1292

• 骨科植入物 orthopedic implant • 上一篇    下一篇

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

杨小广1，王映珍2
  

  1. 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
  • 出版日期:2019-08-28 发布日期:2019-08-28
  • 通讯作者: 杨小广，甘肃省陇南市第一人民医院骨三科，甘肃省陇南市 746000
  • 作者简介:杨小广，副主任医师。

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  

Yang Xiaoguang1, Wang Yingzhen2
  

  1. 1Third Department of Orthopedics, No. 1 Hospital of Longnan City, Longnan 746000, Gansu Province, China; 2Department of Orthopedics, Second Clinical Medical College of Lanzhou University, Lanzhou 730000, Gansu Province, China
  • Online:2019-08-28 Published:2019-08-28
  • Contact: Yang Xiaoguang, Third Department of Orthopedics, No. 1 Hospital of Longnan City, Longnan 746000, Gansu Province, China
  • About author:Yang Xiaoguang, Associate chief physician, Third Department of Orthopedics, No. 1 Hospital of Longnan City, Longnan 746000, Gansu Province, China

PDF

97

摘要：

文章快速阅读：


文题释义：
前交叉韧带胫骨止点撕脱骨折：是临床较为常见一种特殊类型关节内骨折，主要由创伤引起，好发于儿童和青少年，患者骨折后常伴有半月板损害及侧副韧带损伤等。
前交叉韧带胫骨止点：主要位于胫骨髁间嵴的前外侧部位，前交叉韧带不仅能够限制胫骨的迁移和防止过伸，同时当膝关节处于完全伸直位时，其还能够有效对抗内、外翻成角。


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骨折恢复膝关节功能，结果是否安全可靠。


中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程
ORCID: 0000-0003-4332-1392(杨小广)

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

Abstract:

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 3, 6, and 12 months postoperatively. In our pilot study involving 50 patients with anterior cruciate ligament tibial eminence avulsion fractures (50 knees) from October 2015 to January 2018, no patient had joint stiffness or fracture redisplacement on radiography 3 months postoperatively. The mean knee range of motion was significantly larger at 6 months postoperatively compared with preoperatively (P < 0.05). Lysholm Knee Scoring Scale scores and International Knee Documentation Committee scores were significantly improved 6 months postoperatively compared with preoperatively (P < 0.05). This trial will assess the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision to restore knee function in patients with anterior cruciate ligament tibial eminence avulsion fracture.

Key words: anterior cruciate ligament tibial eminence avulsion fracture, open reduction, absorbable screws, internal fixation, Lysholm Knee Scoring Scale score, International Knee Documentation Committee score, self-controlled study

中图分类号: