About this trial
The goal of this observational study is to learn about the outcomes of medial patellofemoral ligament (MPFL) reconstruction for the treatment of recurrent patellar instability. The main questions it aims to answer are:
* What are the risk factors for recurrent patellar instability after MPFL reconstruction? * What functional outcomes do patients report after MPFL reconstruction?
Participants undergoing MPFL reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
10-35 years old
Recurrent patellar instability with at least one episode defined as either (1) a dislocated patella requiring reduction in the emergency department or (2) a convincing history for dislocation, associated with full giving way, and the following physical findings: (a) hemarthrosis or effusion, (b) tenderness along the medial retinaculum, and (c) apprehension when laterally directed force was applied to the patella or (3) MRI-documented dislocation with associated bone bruises
Disqualifiers
Previous ipsilateral knee surgery
Obligatory/fixed/habitual patella dislocation or subluxation
Unloadable inferior or lateral chondral damage on the patella that would require a tibial tubercle transfer for unloading purposes
Pathologic tibiofemoral instability
Trial population
Patients presenting to the participating surgeons for treatment of recurrent patellar instability
Trial design
Cohort
Prospective
Treatments tested in this trial
Medial Patellofemoral Ligament (MPFL) Reconstruction
Procedure/SurgeryFor the purposes of this study, isolated MPFL reconstruction is defined as MPFL reconstruction with a tendon graft, with or without additional soft tissue procedure(s) including lateral retinacular lengthening or release, patellofemoral chondroplasty and/or cartilage restoration. No patient in the study will receive a bony realignment procedure to treat patellar instability.
Treatment groups
Trial outcomes
Primary outcomes
Recurrent patellar instability
Patient-reported patellar dislocation or subluxation
Secondary outcomes
Patient-Reported Outcome Measures (PROMs): Kujala score
The Kujala score, also known as the Anterior Knee Pain Scale (AKPS), is a 13-item questionnaire that helps assess subjective reactions to activities and symptoms related to patellofemoral pain. It is a 0-to-100 point scale, with higher scores indicating better outcomes and less pain and disability.
Patient-Reported Outcome Measures (PROMs): Pedi-IKDC
The Pedi-IDKC is a modified version of the International Knee Documentation Committee (IDKC) Subjective Knee Form for use in young patients. It is a 15-item knee-specific questionnaire that measures symptoms, function, and sports activity. Scores range from 0-100, with higher scores indicating better outcomes.
Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS
The Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS) is a validated 8-item questionnaire scored from 0-30, with higher scores indicating higher levels of activity.
Patient-Reported Outcome Measures (PROMs): KOOS-12
The Knee injury and Osteoarthritis Outcome Score-12 (KOOS-12) is a 12-item measure evaluating the difficulties people experience due to problems with their knee. Each question is scored from 0 to 4 points, with 0 representing no knee problems and 4 representing extreme knee problems. Overall, scores range from 0 to 100, where, in contrast to the individual questions, 0 is the worst possible and 100 is the best possible score.
Sponsors and contacts
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Hospital for Special Surgery, New York
Lead sponsor
American Orthopaedic Society for Sports Medicine
Collaborator
Orthopedic Research and Education Foundation
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator