Clinical trial NCT02333825: Pediatric and Adolescent Patellar Instability
Official title: Pediatric and Adolescent Patellar Instability
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Patellar Instability
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Oregon Health and Science University
name: Inova Medical Group
First posted: 2015-01-07
Enrollment: 240
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Recurrence of patellar instability
timeFrame: 5 years
Secondary outcomes:
measure: Kujala Scoring Questionnaire
timeFrame: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
timeFrame: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
measure: Hospital for Special Surgery Pediatric Functional Activity Brief Scale
timeFrame: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
measure: Outerbridge grade of any cartilage lesions
timeFrame: MRI taken at initial exam, and for patients randomized to surgery only at 1 year and 5 years after surgery as well
Other outcomes:
Locations:
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Beth E Shubin Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University Hospital
name: Jacqueline Munch, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Diane Dahm, MD
role: STUDY_CHAIR
affiliation: Inova Sports Medicine
name: Robin V West, MD
role: STUDY_CHAIR
References: