Pediatric and Adolescent Patellar Instability

Patellar Instability Clinical Trial

— PAPI  

Official title:

Pediatric and Adolescent Patellar Instability

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02333825
• Other study ID #: 2014-087
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patellar Instability

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Inova Medical Group, Mayo Clinic, Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kujala Scoring Questionnaire	The Kujala Scoring Questionnaire is a validated patient reported outcome measure	Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	The KOOS is a validated patient reported outcome measure	Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
Secondary	International Knee Documentation Committee (IKDC) Subjective Knee Evaluation	The IKDC Subjective Knee Evaluation is a validated patient reported outcome measure	Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
Secondary	Hospital for Special Surgery Pediatric Functional Activity Brief Scale	The Hospital for Special Surgery Pediatric Functional Activity Brief Scale is a validated patient reported outcome measure	Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
Secondary	Outerbridge grade of any cartilage lesions	Outerbridge grade will be used to describe the severity of articular cartilage lesions at initial presentation and for surgical patients, 1 and 5 years after treatment as well	MRI taken at initial exam, and for patients randomized to surgery only at 1 year and 5 years after surgery as well

External Links

•   Principle Investigator: Beth Shubin Stein, MD