JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
1 other identifier
observational
850
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 13, 2026
January 1, 2026
3.9 years
January 22, 2025
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent patellar instability
Patient-reported patellar dislocation or subluxation
Within 24 months post-operatively
Secondary Outcomes (6)
Patient-Reported Outcome Measures (PROMs): Kujala score
12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): Pedi-IKDC
12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS
12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): KOOS-12
Time Frame: 12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): BPII 2.0
12 months post-operatively and 24 months post-operatively
- +1 more secondary outcomes
Study Arms (1)
Isolated MPFL Reconstruction
Patients with recurrent patellar instability (2 or more dislocation and/or subluxation events) undergoing isolated MPFL reconstruction
Interventions
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.
Eligibility Criteria
Patients presenting to the participating surgeons for treatment of recurrent patellar instability
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Stanford University
Redwood City, California, 94063, United States
University of Florida
Gainesville, Florida, 32607, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Mount Sinai
New York, New York, 10012, United States
NYU Langone Health
New York, New York, 10016, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Duke Health
Wake Forest, North Carolina, 27587, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Wexler Medical Center
Dublin, Ohio, 43016, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Scottish Rite for Children
Dallas, Texas, 75219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Shubin Stein, MD
Hospital for Special Surgery, New York
- PRINCIPAL INVESTIGATOR
Shital Parikh, MD
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
March 19, 2025
Study Start
January 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
February 13, 2026
Record last verified: 2026-01