JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-35
SponsorHospital for Special Surgery, New York

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Medial Patellofemoral Ligament (MPFL) Reconstruction

    Procedure/Surgery

    For 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

850 Participants
are divided into 1 treatment group
Group A: Isolated MPFL Reconstruction1 intervention

Trial outcomes

Primary outcomes

1

Recurrent patellar instability

Patient-reported patellar dislocation or subluxation

Time frame
Within 24 months post-operatively

Secondary outcomes

1

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.

Time frame
12 months post-operatively and 24 months post-operatively
2

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.

Time frame
12 months post-operatively and 24 months post-operatively
3

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.

Time frame
12 months post-operatively and 24 months post-operatively
4

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.

Time frame
Time Frame: 12 months post-operatively and 24 months post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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