Dynamic versus static medial patellofemoral ligament reconstruction technique in the treatment of recurrent patellar dislocation: a randomized clinical trial protocol

Abstract

Background The redislocation rate of conservatively treated patella instability is high. One of the leading surgical strategies is medial patellofemoral ligament reconstruction. Over-tensioning is one of the most challenging complications in static medial patellofemoral ligament reconstruction as the graft used for reconstruction is isometric and the anatomical MPFL is a mostly dynamic structure. As an alternative to established static reconstruction techniques, dynamic graft techniques have been introduced for stabilizing the patella with the aim of providing a more physiological reconstruction of the medial patellofemoral ligament. To date, data on clinical outcomes are scarce and on biomechanical outcomes of the dynamic MPFL reconstruction are lacking. Here, we present the protocol of a randomized clinical trial for comparing clinical and biomechanical outcomes of dynamic versus static medial patellofemoral ligament reconstruction. Methods This study is a prospective, single blinded, randomized, multicenter, multimodal (clinical and biomechanical) clinical trial. Patients with recurrent patella dislocation requiring isolated MPFL reconstruction will be recruited and randomized to the dynamic or static reconstruction technique. Participants will be followed up for 2 years with a total of five follow-ups. Preoperative magnetic resonance imaging, upright radiographs, surgical reports and patient records will be evaluated, and clinical and functional outcomes will be measured. Patient-reported knee function and anterior knee pain as assessed with the Kujala score will serve as primary outcome. For biomechanical outcome, pre- and postoperative evaluations will be performed to assess isokinetic muscle strength, gait asymmetry, joint kinematics and kinetics, and timing of muscle activity. Discussion The results of the study will clarify whether the reported surgery success for patella stabilization via dynamic MPFL reconstruction is due to muscle contraction or to the passive tenodesis effect combined with clinical outcome measures. With this study, we will provide much needed information on knee biomechanics after dynamic versus static MPFL reconstruction to provide evidence to support orthopedic surgeons in evidence-based decision-making in their quest for surgical techniques most favorable for their patients. Trial registration The study protocol was registered at clinicaltrials.gov (NCT04849130). Registered 19 April 2021, https://clinicaltrials.gov/ct2/show/NCT04849130.