A new fixation and reconstruction method versus arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee posterior cruciate ligament: study protocol for a non-randomized controlled trial and preliminary results
10.3969/j.issn.2095-4344.0120
- VernacularTitle:新型固定重建与关节镜下固定修复膝关节后交叉韧带胫骨止点撕脱骨折:非随机对照试验方案和预试验结果
- Author:
Guang-Dong CHEN
1
;
Yang ZHANG
;
Yong-Jian NI
;
Hong-Mei DU
;
Tong-Jun CAO
;
Zhong-Lin SHAN
Author Information
1. 沧州市中心医院骨三科
- From:
Chinese Journal of Tissue Engineering Research
2018;22(7):1078-1083
- CountryChina
- Language:Chinese
-
Abstract:
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).
