NCT02333825

Pediatric and Adolescent Patellar Instability

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 8 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patellar Instability

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2015-01-07
• Last updated: 2026-02-13