BACKGROUND: Arthroscopic reconstruction for treatment of avulsion fracture at the tibial insertion of the knee posterior cruciate ligament (PCL) can minimize surgical trauma to the largest degree. However, its implants have relatively poor stability; therefore, functional exercise cannot be performed in the early stages after surgery, which is inconducive to knee function recovery. It is extremely challenging to perform traditional open reduction with internal fixation to repair avulsion fractures at the tibial insertion of the knee PCL. Often, the crushed bones cannot be firmly fixed, leading to a poor repair effect. OBJECTIVE: To design a new inverted "L"-shaped incision in the popliteal fossa through which bone plates were inserted to fix the crushed bones and to reconstruct PCL tension, facilitating knee function recovery; to compare the therapeutic effects of this new fixation and reconstruction method, and arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee PCL. METHODS: A prospective, single-center, non-randomized controlled trial. One hundred and eighty patients (knees) with avulsion fracture at the tibial insertion of the knee PCL will be assigned to two groups based on treatment methods: arthroscopic reconstruction group (n = 90;fracture fixation and repair under the arthroscope) and new method group (n = 90; bone plates will be inserted through an "L"-shaped incision in the popliteal fossa to fix the crushed bones and reconstruct PCL tension). After surgery, these patients will be followed up for 6 weeks, 6 months, and 12 months. RESULTS AND CONCLUSION: The primary outcome measure is the excellent and good rate of knee function recovery at 12 months after surgery as evaluated by Lysholm Knee Scoring Scale score (Herein referred to as Lysholm score). The secondary outcome measures are the excellent and good rate of knee function recovery before surgery, 6 weeks and 6 months after surgery; Lysholm score before surgery, 6 weeks, 6 months and 12 months after surgery; Hospital for Special Surgery (HSS) knee score, Visual Analogue Scale (VAS) score, posterior drawer test negative rate, X-ray morphology of the knee before surgery, and 6 weeks, 6 months, and 12 months after surgery and; incidence of adverse events at 6 weeks, 6 months and 12 months after surgery. Results of a preliminary study involving 62 patients (knees) with avulsion fracture at the tibial insertion of the knee PCL showed that posterior drawer test negative rate and Lysholm score were significantly higher in the new method group compared to the arthroscopic reconstruction group (P < 0.05) at 3 months after surgery. This study will be performed to compare the therapeutic effects of bone plate insertion through an "L"-shaped incision made in the popliteal fossa to fix the crushed bones and to reconstruct PCL tension, and traditional fracture fixation and repair under the arthroscope to treat avulsion fracture at the tibial insertion of the knee PCL. We believe that the former method will be superior to the latter one because it can fix the avulsion fracture more firmly, facilitating knee function recovery. This study was approved by Medical Ethics Committee of Cangzhou Central Hospital of China (approval No. 2017-120-01). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Participants provided signed informed consent prior to participation in the study. This study was designed in December 2017. Patient recruitment and data collection will begin in April 2018. Patient recruitment will end in June 2019. Data analysis will be performed in August 2020. The study will be completed in October 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. This trial was registered with the Chinese Clinical Trial Registry (registration number:ChiCTR1800015026). The version of this study protocol is (1.0).%背景:关节镜下手术治疗膝关节交叉韧带胫骨止点撕脱骨折可最大程度地减少手术创伤,但因其植入的固定物牢靠性相对较差,术后早期不能进行功能锻炼,不利于膝关节功能恢复.传统切开复位内固定修复膝关节后交叉韧带胫骨止点撕脱骨折常不能牢靠固定,也影响修复效果.目的:文章设计并提出腘窝倒"L"形切口入路新型接骨板骨折固定及韧带张力重建,牢固固定骨块,并保持良好的韧带张力,有利于膝关节功能恢复,对比观察此方法和关节镜下固定治疗膝关节后交叉韧带胫骨止点撕脱骨折效果的差异.方法:研究为前瞻性、单中心、非随机对照临床试验.将180例(膝)后交叉韧带胫骨止点撕脱骨折患者按治疗方式不同分为2组,关节镜组采用关节镜下固定修复,新型固定重建组采用腘窝倒"L"形切口入路新型接骨板骨折固定并韧带张力重建修复,每组90例(膝),术后随访6周,6,12个月.结果与讨论:研究的主要结局指标为术后12个月以Lysholm评分优良率以评估膝关节功能恢复情况;次要结局指标为术前、术后6周,6个月以Lysholm评分评价膝关节功能恢复优良率,术前、术后6周,6,12个月膝关节Lysholm评分、HSS评分、目测类比评分、后抽屉试验阴性率及膝关节X射线形态;术后6周, 6,12个月的不良反应发生率.稿件提交时作者已获得62例(膝)的预试验结果显示,术后3个月,与关节镜组比较,新型固定重建组的后抽屉试验阴性率及Lysholm评分均升高(P < 0.05).试验的目的在于和关节镜下内固定相比,评价腘窝倒"L"形切口入路新型接骨板骨折固定并韧带张力重建修复膝关节后交叉韧带胫骨止点撕脱骨折效果的差异,在骨折牢靠固定,更有利于患者膝关节功能恢复方面更有优势.试验经沧州市中心医院医学伦理委员会批准(审批单位:沧州市中心医院,审批号:2017-120-01).研究符合世界医学会制定的《赫尔辛基宣言》的要求.参与者本人对试验方案和过程均知情同意,并签署知情同意书.试验设计时间为2017年1月,试验于2018年4月至开始进行患者招募及数据收集,2019年6月招募结束,2020年8月进行结果指标分析,2020年10月试验完成.文章结果将以科学会议报告,或在同行评议的期刊上发表传播.试验已在中国临床试验注册中心注册(注册号:ChiCTR1800015026),注册方案版本号1.0.
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