Pediatric and Adolescent Patellar Instability
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-002168
NCT ID: NCT02333825
Sponsor Protocol Number: 2014-087
About this study
This is a multi-center, randomized controlled clinical trial, the purpose of which is to determine if skeletally immature patients who undergo medial patellofemoral ligament (MPFL) reconstruction have lower rates of recurrent instability compared to those treated non-operatively. The MPFL is a ligament that stabilizes the kneecap, and maintains its proper position in the groove on the femur (thighbone). Instability refers to a situation in which the kneecap moves out of place, or dislocates. When instability is recurrent, it occurs more than once in the same knee.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Must be skeletally immature, still growing
- Must be first-time dislocators, meaning have had only one episode of patellar instability, during which they dislocated their patella (kneecap)
Exclusion Criteria
- Has had more than one episode of patellofemoral instability
- Has had prior patellofemoral surgery on the knee of interest
- Has large cartilage tears in the knee and will undergo stabilization of the patellofemoral joint (MPFL reconstruction) as per standard of care
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Diane Dahm, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available