Non-absorbable surgical sutures versus autologous tendons in the reconstruction of medial patellofemoral ligaments: a randomised controlled trial protocol

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: ChiCTR2200057574.

Keywords: Clinical Trial; Knee; Musculoskeletal disorders; Orthopaedic & trauma surgery; Orthopaedic sports trauma; Randomized Controlled Trial.

Figure 1. Study flow diagram. MPFLR, medial patellofemoral ligament reconstruction.

Figure 2. Medial patellofemoral ligament reconstruction with FiberWire.

Figure 3. Medial patellofemoral ligament reconstruction with semitendinosus tendon.

Figure 4. Example template of recommended content for the schedule of enrolment, interventions and assessments. IKDC, International Knee Documentation Committee; MPFL, medial patellofemoral ligament; SF-12, 12-Item Short Form Survey; VAS, Visual Analogue Scale.

** The different time periods of follow-up and the tasks to be completed during each time period.