Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Orthopaedic Society for Sports Medicine | OTHER |
| Orthopedic Research and Education Foundation | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Participants undergoing MPFL reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolated MPFL Reconstruction | Patients with recurrent patellar instability (2 or more dislocation and/or subluxation events) undergoing isolated MPFL reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial Patellofemoral Ligament (MPFL) Reconstruction | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent patellar instability | Patient-reported patellar dislocation or subluxation | Within 24 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post-operatively and 24 months post-operatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients presenting to the participating surgeons for treatment of recurrent patellar instability
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone Gruber | Contact | 646-797-8947 | grubers@hss.edu | |
| Natalie Pahapill | Contact | 646-714-6738 | pahapilln@hss.edu |
| Name | Affiliation | Role |
|---|---|---|
| Beth Shubin Stein, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Shital Parikh, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Redwood City | California | 94063 | United States |
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | 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. | 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). | 12 months post-operatively and 24 months post-operatively |
| University of Florida | Recruiting | Gainesville | Florida | 32607 | United States |
|
| Midwest Orthopaedics at Rush | Recruiting | Chicago | Illinois | 60612 | United States |
|
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Mayo Clinic | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
|
| Mount Sinai | Not yet recruiting | New York | New York | 10012 | United States |
|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
|
| Duke Health | Recruiting | Wake Forest | North Carolina | 27587 | United States |
|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
|
| Ohio State University Wexler Medical Center | Recruiting | Dublin | Ohio | 43016 | United States |
|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| Scottish Rite for Children | Recruiting | Dallas | Texas | 75219 | United States |
|
| ID | Term |
|---|---|
| D031222 | Patellar Dislocation |
| D012008 | Recurrence |
| D000092462 | Patella Fracture |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092443 | Knee Fractures |
| D050723 | Fractures, Bone |
Not provided
Not provided
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided