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

NCT ID: NCT06883396

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patellar Dislocation, Recurrent Patellar Dislocation Patellar Instability Patellofemoral Dislocation Patellofemoral Joint Dislocation Patellofemoral Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Isolated MPFL Reconstruction

Patients with recurrent patellar instability (2 or more dislocation and/or subluxation events) undergoing isolated MPFL reconstruction

Medial Patellofemoral Ligament (MPFL) Reconstruction

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Orthopaedic Society for Sports Medicine

OTHER

Sponsor Role collaborator

Orthopedic Research and Education Foundation

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beth Shubin Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Shital Parikh, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Stanford University

Redwood City, California, United States

Site Status RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Midwest Orthopaedics at Rush

Chicago, Illinois, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status NOT_YET_RECRUITING

Mount Sinai

New York, New York, United States

Site Status NOT_YET_RECRUITING

NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Hospital for Special Surgery

New York, New York, United States

Site Status RECRUITING

Duke Health

Wake Forest, North Carolina, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

Ohio State University Wexler Medical Center

Dublin, Ohio, United States

Site Status RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Scottish Rite for Children

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Simone Gruber

Role: CONTACT

646-797-8947

Natalie Pahapill

Role: CONTACT

646-714-6738

Facility Contacts

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Monica Sri Vel

Role: primary

Tyler LaMonica

Role: primary

Role: primary

Shannon Ortiz

Role: primary

Serafina Zotter

Role: primary

Emma Gossman

Role: primary

Michael Quinn

Role: backup

Karina Gonzalez Carta, MD

Role: primary

Dave Sejal

Role: backup

Simone Gruber

Role: primary

646-797-8947

Ivanka Bhambhani

Role: primary

Simone Gruber

Role: primary

646-797-8947

Natalie Pahapill

Role: backup

646-714-6738

Courtney Pyles

Role: primary

Cassandra Rhodes

Role: backup

Matthew Veerkamp

Role: primary

513-636-3775

Jennifer Baldwin

Role: primary

Michael Keller

Role: primary

Albert Yim

Role: primary

Bayley Selee

Role: primary

Antonia Dinulescu

Role: backup

Other Identifiers

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2022-0649

Identifier Type: -

Identifier Source: org_study_id

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