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

February 11, 2026 updated by: Hospital for Special Surgery, New York

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The JUPITER group consists of high-volume patellofemoral surgeons across the United States, and was organized to facilitate the collection of clinical and radiographic outcomes following surgical and non-surgical treatment of patellar instability. With this study (JUPITER 4.0), the group aims to prospectively enroll a new cohort of consecutive patients with recurrent patellar instability that would undergo isolated MPFL reconstruction regardless of radiographic measurements or anatomic risk factors to address two specific aims - 1) what patient, injury, and surgical factors lead to recurrent instability following isolated MPFL reconstruction and 2) the creation of an instability severity index score, with the long-term objective of identifying preoperatively, patients with a high risk of failure of an isolated MPFL reconstruction who may be better served with concomitant bony procedure.

Study Type

Observational

Enrollment (Estimated)

850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford University
        • Contact:
        • Sub-Investigator:
          • Seth L Sherman, MD
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • University of Florida
        • Contact:
        • Sub-Investigator:
          • Ryan P Roach, MD
        • Sub-Investigator:
          • Kevin W Farmer, MD
    • Illinois
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Sub-Investigator:
          • Robert W Westermann, MD
        • Sub-Investigator:
          • Matthew J Bollier, MD, FAOA
        • Sub-Investigator:
          • Kyle Duchman, MD
        • Sub-Investigator:
          • Brian Wolf, MD, MS
    • Massachusetts
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
        • Sub-Investigator:
          • Mario Hevesi, MD, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Todd A Milbrandt, MD
        • Sub-Investigator:
          • Adam J Tagliero, MD
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Beth Shubin Stein, MD
        • Sub-Investigator:
          • Daniel Green, MD, MS, FAAP, FACS
      • New York, New York, United States, 10012
        • Not yet recruiting
        • Mount Sinai
        • Contact:
        • Sub-Investigator:
          • Elizabeth Dennis, MD
    • North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Shital Parikh, MD
        • Sub-Investigator:
          • Eric Wall, MD
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Sub-Investigator:
          • Lutul Farrow, MD
        • Sub-Investigator:
          • Paul Saluan, MD
        • Contact:
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Ohio State University Wexler Medical Center
        • Contact:
        • Sub-Investigator:
          • Robert A Magnussen, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Sub-Investigator:
          • Jacqueline Brady, MD
    • Texas
      • Dallas, Texas, United States, 75219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the participating surgeons for treatment of recurrent patellar instability

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Isolated MPFL Reconstruction
Patients with recurrent patellar instability (2 or more dislocation and/or subluxation events) undergoing isolated MPFL reconstruction
Procedure: Medial Patellofemoral Ligament (MPFL) Reconstruction
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent patellar instability
Time Frame: Within 24 months post-operatively
Patient-reported patellar dislocation or subluxation
Within 24 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcome Measures (PROMs): Kujala score
Time Frame: 12 months post-operatively and 24 months post-operatively
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.
12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): Pedi-IKDC
Time Frame: 12 months post-operatively and 24 months post-operatively
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.
12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS
Time Frame: 12 months post-operatively and 24 months post-operatively
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.
12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): KOOS-12
Time Frame: Time Frame: 12 months post-operatively and 24 months post-operatively
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: 12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): BPII 2.0
Time Frame: 12 months post-operatively and 24 months post-operatively
The BPII 2.0 (Banff Patellofemoral Instability Instrument) is a patient-reported outcome measure assessing quality of life in individuals with patellofemoral instability. The score ranges from 0 to 100, with higher scores indicating greater quality of life.
12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): PROMIS-29
Time Frame: 12 months post-operatively and 24 months post-operatively
PROMIS (Patient-Reported Outcomes Measurement Information System) is a questionnaire that evaluates health-related quality of life across seven key domains: physical function, pain interference, fatigue, sleep disturbance, physical and mental health, and social health. It is scored a T-score metric. High scores mean more of the concept being measured. 10 points on the T-score metric is one standard deviation (SD).
12 months post-operatively and 24 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

Children's Hospital Medical Center, Cincinnati
American Orthopaedic Society for Sports Medicine
Orthopedic Research and Education Foundation

Investigators

  • Principal Investigator: Beth Shubin Stein, MD, Hospital for Special Surgery, New York
  • Principal Investigator: Shital Parikh, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0649

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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