Pediatric and Adolescent Patellar Instability

NCT02333825 | Enrolling By Invitation DMC

• 1 other identifier: 2014-087
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patellar Instability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Kujala Scoring Questionnaire

  Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.

• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation

  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

  Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.

• Outerbridge grade of any cartilage lesions

  MRI taken at initial exam, and for patients randomized to surgery only at 1 year and 5 years after surgery as well

Study Arms (2)

Surgical Intervention

OTHER

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.

Procedure: Medial patellofemoral ligament reconstruction surgery

Conservative treatment

OTHER

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.

Other: Physical therapy and rehabilitation

Interventions

Medial patellofemoral ligament reconstruction surgery PROCEDURE

Medial patellofemoral ligament reconstruction surgery using hamstring autograft

Also known as: CPT code: 27427

Surgical Intervention

Physical therapy and rehabilitation OTHER

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

Conservative treatment

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Mayo Clinic: collaborator
• Oregon Health and Science University: collaborator
• Inova Medical Group: collaborator

Related Links

• Principle Investigator: Beth Shubin Stein, MD

MeSH Terms

Interventions

Physical Therapy Modalities; Rehabilitation

Intervention Hierarchy (Ancestors)

Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Beth E Shubin Stein, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

• Jacqueline Munch, MD

  Oregon Health and Science University Hospital

  STUDY CHAIR

• Diane Dahm, MD

  Mayo Clinic

  STUDY CHAIR

• Robin V West, MD

  Inova Sports Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: January 7, 2015
• Study Start: December 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2024-02