Patellar Instability Clinical Trial
— PAPIOfficial title:
Pediatric and Adolescent Patellar Instability
Verified date | February 2024 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multi-center, randomized controlled clinical trial, the purpose of which is to determine if patients age 25 and younger 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.
Status | Enrolling by invitation |
Enrollment | 240 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 25 Years |
Eligibility | Inclusion Criteria: - Patients must be age 25 or younger - Patients must be first-time dislocators, meaning have had only one episode of patellar instability, during which they dislocated their patella (kneecap) Exclusion Criteria: - Patients with more than one episode of patellofemoral instability - Patients who have had prior patellofemoral surgery on the knee of interest - Patients with large cartilage tears in the knee. These patients will undergo stabilization of the patellofemoral joint (MPFL reconstruction) as per standard of care, and will not be included in the study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hospital for Special Surgery, New York | Inova Medical Group, Mayo Clinic, Oregon Health and Science University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of patellar instability | The primary outcome is recurrent episode of patellar instability within 5 years following the primary patellofemoral dislocation event. A preliminary analysis will be performed at 2 years to examine for any early results of the study. Patellar instability will be defined as any patient-reported episode of subluxation or dislocation following the index event. Subluxation or dislocation will be defined as a feeling of dissociation of the patella from its trochlear groove. Subluxation will be noted if the patella spontaneously reduces into the groove, and dislocation will be noted if the patella requires any change in position or force (i.e. extending the knee or exerting a medially-directed force on the patella) in order to reduce into its trochlear groove. (Apprehension will not be classified as subluxation unless the patient specifically notes a sensation of departure of the patella from its trochlear groove at some point during the experience.) | 5 years | |
Secondary | Kujala Scoring Questionnaire | The Kujala Scoring Questionnaire is a validated patient reported outcome measure | Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment. | |
Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS is a validated patient reported outcome measure | Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment. | |
Secondary | International Knee Documentation Committee (IKDC) Subjective Knee Evaluation | The IKDC Subjective Knee Evaluation is a validated patient reported outcome measure | Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment. | |
Secondary | Hospital for Special Surgery Pediatric Functional Activity Brief Scale | The Hospital for Special Surgery Pediatric Functional Activity Brief Scale is a validated patient reported outcome measure | Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment. | |
Secondary | Outerbridge grade of any cartilage lesions | Outerbridge grade will be used to describe the severity of articular cartilage lesions at initial presentation and for surgical patients, 1 and 5 years after treatment as well | MRI taken at initial exam, and for patients randomized to surgery only at 1 year and 5 years after surgery as well |
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