NCT06883396

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2023Dec 2027

Study Start

First participant enrolled

January 1, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

January 22, 2025

Last Update Submit

February 11, 2026

Conditions

Keywords

PatellaPatella DislocationPatellar InstabilityRecurrent Patellar InstabilityMPFLMedial Patellofemoral LigamentMedial Patellofemoral Ligament ReconstructionPatellofemoral Instability

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

Procedure: Medial Patellofemoral Ligament (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.

Isolated MPFL Reconstruction

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

University of Florida

Gainesville, Florida, 32607, United States

RECRUITING

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Mount Sinai

New York, New York, 10012, United States

NOT YET RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Duke Health

Wake Forest, North Carolina, 27587, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Ohio State University Wexler Medical Center

Dublin, Ohio, 43016, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Scottish Rite for Children

Dallas, Texas, 75219, United States

RECRUITING

MeSH Terms

Conditions

Patellar DislocationRecurrencePatella Fracture

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsKnee FracturesFractures, Bone

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Beth Shubin Stein, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR
  • Shital Parikh, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Gruber

CONTACT

Natalie Pahapill

CONTACT

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

Locations