Pan Linyuan, Liu Gaoming, Lu Wenhao, Liu Xu, Jin Hongfu, Xiao Wenfeng, Li Yusheng
Department of Orthopedic, Xiangya Hospital Central South University, Changsha, Hunan, China.
National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China.
BMJ Open. 2024 Dec 3;14(12):e084187. doi: 10.1136/bmjopen-2024-084187.
Arthroscopic-assisted medial patellofemoral ligament reconstruction (MPFLR) is a common surgical procedure for patellar dislocation. We present the protocol of a randomised controlled clinical trial to compare postoperative pain, knee function and quality of life outcomes of MPFL reconstruction using the non-absorbable surgical sutures (FiberWire) and semitendinosus tendon.
This single-blind, randomised controlled trial enrolled patients with patellar dislocation who were undergoing inpatient surgery at the Department of Orthopedics, Xiangya Hospital, Central South University. Participants were randomly allocated to either the experimental or the control group using a random number table method, with an equal number of 15 subjects in each group. The experimental group was treated with a FiberWire for the MPFLR, whereas the control group received reconstruction using the semitendinosus tendon. A standardised postoperative rehabilitation protocol was implemented for both groups. All subjects will be evaluated for imaging, pain, knee function and quality of life at five time points: preoperatively and at 1 month, 3 months, 6 months and 12 months postoperatively. MRI scans will be performed preoperatively and at 12 months postoperatively to assess changes in patellar tilt angles and congruence angles. Pain assessment is performed using the Visual Analogue Scale (VAS). Knee function will be assessed using the Kujala score, Lysholm score and International Knee Documentation Committee (IKDC) knee function score. Quality of life was assessed using the 12-Item Short Form Survey scale.
The trial was approved by the Medical Ethics Committee of Xiangya Hospital of Central South University on 26 October 2021 (ethics number: 202110478) and registered in the China Clinical Trials Registry on 15 March 2022. Data will be published in peer-reviewed journals and presented at national and international conferences.
ChiCTR2200057574.
关节镜辅助下内侧髌股韧带重建术（MPFLR）是治疗髌骨脱位的常见外科手术。我们展示了一项随机对照临床试验的方案，以比较使用不可吸收手术缝线（FiberWire）和半腱肌腱进行MPFL重建术后的疼痛、膝关节功能和生活质量结果。
这项单盲随机对照试验纳入了在中南大学湘雅医院骨科接受住院手术的髌骨脱位患者。采用随机数字表法将参与者随机分为试验组或对照组，每组各15名受试者。试验组采用FiberWire进行MPFLR治疗，而对照组则采用半腱肌腱进行重建。两组均实施标准化的术后康复方案。所有受试者将在五个时间点接受影像学、疼痛、膝关节功能和生活质量评估：术前以及术后1个月、3个月、6个月和12个月。术前和术后12个月将进行MRI扫描，以评估髌骨倾斜角和匹配角的变化。使用视觉模拟量表（VAS）进行疼痛评估。膝关节功能将使用库贾拉评分、 Lysholm评分和国际膝关节文献委员会（IKDC）膝关节功能评分进行评估。使用12项简明调查量表评估生活质量。
该试验于2021年10月26日获得中南大学湘雅医院医学伦理委员会批准（伦理编号：202110478），并于2022年3月15日在中国临床试验注册中心注册。数据将发表在同行评审期刊上，并在国内和国际会议上展示。
ChiCTR2200057574。
