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Actively Recruiting

Researchers are evaluating whether repairing the medial patellofemoral ligament (MPFL) using a biologic implant called Biobrace® can lower the chances of the kneecap dislocating again after a first-time lateral patellofemoral dislocation. This condition is common among young people and can lead to repeated knee instability. The study focuses on patients aged 13 to 30 years with mild to moderate risk factors and aims to see if this surgical approach reduces recurrence compared to natural healing. Currently, no synthetic treatment offers both strength and biological support for ligament healing as Biobrace® does. Participants will receive MPFL repair surgery augmented with the Biobrace® implant to support the ligament during healing and help keep the kneecap centered in the groove of the thigh bone. The study will compare this treatment to the typical natural course of patellar instability after a first dislocation. The Biobrace® device is designed to reinforce soft tissues where weakness exists and to promote biological healing while providing mechanical support. During the study, participants will be monitored for two years to track any repeated dislocations of the patella. Researchers will collect data through questionnaires and clinical evaluations to assess knee stability and function. Safety and effectiveness of the MPFL repair with Biobrace® augmentation will be evaluated over this time to determine if the treatment helps reduce recurrence and improves patient outcomes.

Age: 13Years - 30YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are investigating the effects of tibial tubercle osteotomy (TTO) on both subjective and objective outcomes after medial patellofemoral ligament reconstruction (MPFL-R) in patients with an increased tibial tubercle-trochlear groove (TT-TG) distance, with or without patella alta. This pilot randomized clinical trial (RCT) aims to assess the feasibility of recruiting patients, adherence to the study protocol, and completion rates of patient follow-up at least 12 months after surgery. The study focuses on individuals with recurrent lateral patellofemoral instability. Participants will be randomly assigned to one of two groups: isolated MPFL-R or MPFL-R combined with a correcting TTO (which may involve medializing, distalizing, or both). MPFL-R involves using a soft tissue graft to reconstruct the ligament between the medial patella and femur, while TTO is a surgical procedure that repositions the patellar tendon insertion to improve knee stability. Both procedures are performed to address patellofemoral instability and related anatomical issues. During the study, patients will be followed for two years post-operation, with assessments including subjective outcome measures, clinical evaluations, and functional tests. Researchers will monitor recruitment success, protocol adherence, and follow-up completion at 12 months. Secondary outcomes include patient-reported instability scores, complications, re-dislocation rates, pain levels, satisfaction, and other functional and clinical results to help guide future larger trials.

Age: 13Years - 30YearsAll GendersPhase Not Applicable
1 location
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