Pediatric and Adolescent Patellar Instability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medial patellofemoral ligament reconstruction surgery, Physical therapy and rehabilitation.
- Who it may be relevant to
- Registry conditions: Patellar Instability. Basic parameters: 8 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
A total of 240 patients will be enrolled across participating sites around the country. These sites currently include: The Hospital for Special Surgery, Oregon Health and Science University, Inova Sports Medicine, and Mayo Clinic. Patients are randomly assigned to one of two treatment groups. Patients assigned to the "stabilization" group will undergo surgery to reconstruct the MPFL using either a hamstring tendon that is your own or one obtained from a donor. Patients assigned to the "conservative" group will be treated with physical therapy, and possibly a simple knee arthroscopy if you are found to have a loose fragment on x-ray or MRI. All patients will be required to return for follow-up visits, which will continue over the course of 5 years. During these visits, patients will be examined, asked to answer questions about their surgery and general health, and have imaging (x-ray and MRI) performed on the knee. All patients enrolled in this study will undergo a standardized, intensive rehabilitation protocol. The investigators anticipate that all patients may benefit from extensive rehabilitation, including strengthening and return to sport training. The knowledge gained from this study may benefit others in the future.
Interventions
- Procedure Medial patellofemoral ligament reconstruction surgery
Medial patellofemoral ligament reconstruction surgery using hamstring autograft - Other Physical therapy and rehabilitation
A standardized physical therapy and rehabilitation program to be administered and guided by rehab specialists
Primary outcome measures
- Recurrence of patellar instability [Time frame: 5 years]
Secondary outcome measures (5)
- Kujala Scoring Questionnaire [Time frame: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.]
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.]
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation [Time frame: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.]
- Hospital for Special Surgery Pediatric Functional Activity Brief Scale [Time frame: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.]
- Outerbridge grade of any cartilage lesions [Time frame: MRI taken at initial exam, and for patients randomized to surgery only at 1 year and 5 years after surgery as well]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT02333825 · 2014-087