Patellar Dislocation, RecurrentNCT06883396
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
An observational study of Patellar Dislocation, Recurrent and Patellar Dislocation, run by Hospital for Special Surgery, New York at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- Patellar Dislocation, Recurrent, Patellar Dislocation, Patellar Instability
- What is being tested?
- Medial Patellofemoral Ligament (MPFL) Reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 850 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Jan 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients presenting to the participating surgeons for treatment of recurrent patellar instability
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Serafina Zotter, szotter@mgh.harvard.edu
Nikolaos Paschos, MD, PhD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Emma Gossman, Emma.Gossman@childrens.harvard.edu
Michael Quinn, Michael.Quinn@childrens.harvard.edu
- Recruiting
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
cartilage.restoration@rushortho.com
Adam B Yanke, MD, PhD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Matthew Veerkamp, 513-636-3775, Matthew.Veerkamp@cchmc.org
Shital Parikh, MD
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Jennifer Baldwin, BALDWIJ3@ccf.org
Lutul Farrow, MD
- Recruiting
Scottish Rite for Children
Dallas, Texas, 75219
Bayley Selee, Bayley.Selee@tsrh.org
Antonia Dinulescu, antonia.dinulescu@tsrh.org
- Recruiting
Ohio State University Wexler Medical Center
Dublin, Ohio, 43016
Michael Keller, Michael.Keller@osumc.edu
Robert A Magnussen, MD
- Recruiting
University of Florida
Gainesville, Florida, 32607
Tyler LaMonica, lamontj@ortho.ufl.edu
Ryan P Roach, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Shannon Ortiz, shannon-ortiz@uiowa.edu
Robert W Westermann, MD
- Not yet recruiting
Mount Sinai
New York, New York, 10012
Simone Gruber, 646-797-8947, grubers@hss.edu
Elizabeth Dennis, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Ivanka Bhambhani, Ivanka.Bhambhani@nyulangone.org
Eric J Strauss, MD
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Simone Gruber, 646-797-8947, grubers@hss.edu
Natalie Pahapill, 646-714-6738, pahapilln@hss.edu
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Albert Yim, yima@ohsu.edu
Jacqueline Brady, MD
- Recruiting
Stanford University
Redwood City, California, 94063
Monica Sri Vel, msvel@stanford.edu
Seth L Sherman, MD
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Karina Gonzalez Carta, MD, Carta.Karina@mayo.edu
Dave Sejal, Dave.Sejal@mayo.edu
- Recruiting
Duke Health
Wake Forest, North Carolina, 27587
Courtney Pyles, courtney.pyles@duke.edu
Cassandra Rhodes, cassandra.rhodes@duke.edu
About this study
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.
Read the 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.
- Conditions
- Patellar Dislocation, Recurrent, Patellar Dislocation, Patellar Instability, Patellofemoral Dislocation, Patellofemoral Joint Dislocation, Patellofemoral Disorder
- Being tested
- Medial Patellofemoral Ligament (MPFL) Reconstruction
- Keywords
- Patella, Patella Dislocation, Patellar Instability, Recurrent Patellar Instability, MPFL, Medial Patellofemoral Ligament, Medial Patellofemoral Ligament Reconstruction, Patellofemoral Instability
- Medical subject headings
- Patellar Dislocation, Recurrence, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial Patellofemoral Ligament (MPFL) ReconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Isolated MPFL Reconstruction | Patients with recurrent patellar instability (2 or more dislocation and/or subluxation events) undergoing isolated MPFL reconstruction Receives: Procedure: Medial Patellofemoral Ligament (MPFL) Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent patellar instability
Patient-reported patellar dislocation or subluxation
Measured: Within 24 months post-operatively
Secondary outcomes (6)
Patient-Reported Outcome Measures (PROMs): Kujala score
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.
Measured: 12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): Pedi-IKDC
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.
Measured: 12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS
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.
Measured: 12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): KOOS-12
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.
Measured: Time Frame: 12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): BPII 2.0
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.
Measured: 12 months post-operatively and 24 months post-operatively
Patient-Reported Outcome Measures (PROMs): PROMIS-29
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).
Measured: 12 months post-operatively and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar Dislocation, RecurrentStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- American Orthopaedic Society for Sports Medicine, Orthopedic Research and Education Foundation, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Beth Shubin Stein, MD, Principal investigator, Hospital for Special Surgery, New YorkShital Parikh, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883396
- Sponsor's protocol ID
- 2022-0649
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06883396
- Acronym / sponsor ID
- 2022-0649
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- American Orthopaedic Society for Sports Medicine, Orthopedic Research and Education Foundation, Children's Hospital Medical Center, Cincinnati
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isolated MPFL Reconstruction | – | Procedure: Medial Patellofemoral Ligament (MPFL) ReconstructionPatients with recurrent patellar instability (2 or more dislocation and/or subluxation events) undergoing isolated MPFL reconstruction |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients presenting to the participating surgeons for treatment of recurrent patellar instability
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial Patellofemoral Ligament (MPFL) ReconstructionFor 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. | Procedure or surgery | Isolated MPFL Reconstruction |
Primary outcome
Recurrent patellar instability
Time frame: Within 24 months post-operatively
Patient-reported patellar dislocation or subluxation
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
Related trials for Patellar Dislocation, Recurrent
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Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children
Recurrent Patellar Displacement, MPFL
Recruiting
Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
Patellar Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beth Shubin Stein, MD principal investigator
Hospital for Special Surgery, New York
Shital Parikh, MD principal investigator
Children's Hospital Medical Center, Cincinnati
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellar Dislocation, Recurrent and Patellar Dislocation, run by Hospital for Special Surgery, New York at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Gruber (646-797-8947, grubers@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent patellar instability (time frame: Within 24 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.