Pediatric and Adolescent Patellar Instability

NCT ID: NCT02333825

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2026-12-31

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.

Conditions

Patellar Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Surgical Intervention

The surgical intervention to be studied in this arm is medial patellofemoral ligament reconstruction surgery using hamstring tendon. The tendon used will generally consist of autograft semitendinosus. If the hamstrings have been previously harvested or injured (i.e. in the setting of anterior cruciate ligament reconstruction or proximal tibial surgery), or if the patient/his or her family prefers to minimize donor site morbidity, allograft may be used.

Group Type: OTHER

Medial patellofemoral ligament reconstruction surgery

Intervention Type: PROCEDURE

Medial patellofemoral ligament reconstruction surgery using hamstring autograft

Conservative treatment

The intervention to be studied in this arm is a rehabilitation program directed by physical therapists. If patients in this arm are found to have a small loose body, a simple arthroscopy will be performed to remove the loose body, but no stabilization of the patellofemoral joint will be performed. The rehabilitation program will be compiled into a booklet and distributed for use by the physical therapist chosen by the patient.

Group Type: OTHER

Physical therapy and rehabilitation

Intervention Type: OTHER

A standardized physical therapy and rehabilitation program to be administered and guided by rehab specialists

Interventions

Medial patellofemoral ligament reconstruction surgery

Medial patellofemoral ligament reconstruction surgery using hamstring autograft

Intervention Type: PROCEDURE

Physical therapy and rehabilitation

A standardized physical therapy and rehabilitation program to be administered and guided by rehab specialists

Intervention Type: OTHER

Other Intervention Names

CPT code: 27427

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Inova Medical Group

UNKNOWN

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beth E Shubin Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Jacqueline Munch, MD

Role: STUDY_CHAIR

Oregon Health and Science University Hospital

Diane Dahm, MD

Role: STUDY_CHAIR

Mayo Clinic

Robin V West, MD

Role: STUDY_CHAIR

Inova Sports Medicine

Related Links

http://www.hss.edu/physicians_shubin-stein-beth.asp

Principle Investigator: Beth Shubin Stein, MD

Other Identifiers

2014-087

Identifier Type: -

Identifier Source: org_study_id