Clinical trial NCT06883396: JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Official title: JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patellar Dislocation, Recurrent
Patellar Dislocation
Patellar Instability
Patellofemoral Dislocation
Patellofemoral Joint Dislocation
Patellofemoral Disorder
Keywords: Patella
Patella Dislocation
Patellar Instability
Recurrent Patellar Instability
MPFL
Medial Patellofemoral Ligament
Medial Patellofemoral Ligament Reconstruction
Patellofemoral Instability
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: American Orthopaedic Society for Sports Medicine
name: Orthopedic Research and Education Foundation
name: Children's Hospital Medical Center, Cincinnati
First posted: 2025-03-19
Enrollment: 850
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the participating surgeons for treatment of recurrent patellar instability

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.

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.

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

Primary outcomes:
measure: Recurrent patellar instability
timeFrame: Within 24 months post-operatively
Secondary outcomes:
measure: Patient-Reported Outcome Measures (PROMs): Kujala score
timeFrame: 12 months post-operatively and 24 months post-operatively
measure: Patient-Reported Outcome Measures (PROMs): Pedi-IKDC
timeFrame: 12 months post-operatively and 24 months post-operatively
measure: Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS
timeFrame: 12 months post-operatively and 24 months post-operatively
measure: Patient-Reported Outcome Measures (PROMs): KOOS-12
timeFrame: Time Frame: 12 months post-operatively and 24 months post-operatively
measure: Patient-Reported Outcome Measures (PROMs): BPII 2.0
timeFrame: 12 months post-operatively and 24 months post-operatively
measure: Patient-Reported Outcome Measures (PROMs): PROMIS-29
timeFrame: 12 months post-operatively and 24 months post-operatively
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Wake Forest
country: United States
facility: Duke Health
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dublin
country: United States
facility: Ohio State University Wexler Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: Scottish Rite for Children
state: Texas
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Beth Shubin Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Shital Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References: