Patellar Dislocation, Patellar Dislocation, Recurrent, Patellar Instability, Patellofemoral Dislocation, Patellofemoral Disorder, Patellofemoral Joint Dislocation
Conditions
Keywords
Patella, Patella Dislocation, Patellar Instability, Recurrent Patellar Instability, MPFL, Medial Patellofemoral Ligament, Medial Patellofemoral Ligament Reconstruction, Patellofemoral 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.
Interventions
PROCEDUREMedial 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.
Sponsors
Hospital for Special Surgery, New York
American Orthopaedic Society for Sports Medicine
Orthopedic Research and Education Foundation
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent patellar instability | Within 24 months post-operatively | Patient-reported patellar dislocation or subluxation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcome Measures (PROMs): Kujala score | 12 months post-operatively and 24 months post-operatively | 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. |
| Patient-Reported Outcome Measures (PROMs): Pedi-IKDC | 12 months post-operatively and 24 months post-operatively | 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. |
| Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS | 12 months post-operatively and 24 months post-operatively | 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. |
| Patient-Reported Outcome Measures (PROMs): KOOS-12 | Time Frame: 12 months post-operatively and 24 months post-operatively | 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. |
| Patient-Reported Outcome Measures (PROMs): BPII 2.0 | 12 months post-operatively and 24 months post-operatively | 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. |
| Patient-Reported Outcome Measures (PROMs): PROMIS-29 | 12 months post-operatively and 24 months post-operatively | 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). |
Countries
United States
Contacts
CONTACTSimone Gruber
CONTACTNatalie Pahapill
PRINCIPAL_INVESTIGATORBeth Shubin Stein, MD
Hospital for Special Surgery, New York
PRINCIPAL_INVESTIGATORShital Parikh, MD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed