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Recruiting NCT06883396

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

— Observational Patellar Dislocation, Recurrent Patellar Dislocation Patellar Instability Patellofemoral Dislocation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medial Patellofemoral Ligament (MPFL) Reconstruction.
Who it may be relevant to
Registry conditions: Patellar Dislocation, Recurrent, Patellar Dislocation, Patellar Instability, Patellofemoral Dislocation. Basic parameters: 10 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • Recurrent patellar instability [Time frame: Within 24 months post-operatively]
Secondary outcome measures (6)
  • Patient-Reported Outcome Measures (PROMs): Kujala score [Time frame: 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]
  • Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS [Time frame: 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]
  • Patient-Reported Outcome Measures (PROMs): BPII 2.0 [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 16 centers
  • Stanford University — Redwood City
  • University of Florida — Gainesville
  • Midwest Orthopaedics at Rush — Chicago
  • University of Iowa — Iowa City
  • Massachusetts General Hospital — Boston
  • Boston Children's Hospital — Boston
  • Mayo Clinic — Rochester
  • Mount Sinai — New York
  • … and 8 more centers

Identifiers

NCT: NCT06883396 · 2022-0649

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗