Effect of Early Range of Motion Following First Time Patellar Dislocation

Not Applicable

Active, not recruiting

• Conditions: Patellar Dislocation
• Interventions: Other: Early Range of MOtion

• Registration Number: NCT04294199
• Lead Sponsor: Baylor College of Medicine

Brief Summary

Do teen-age patients with a dislocated knee cap do better with or without a brace?

Detailed Description

This study will look at two different ways to treat teen-age patients who have had a dislocation of their knee cap. Both groups will receive the physical therapy treatment for knee cap dislocation but one group will first be in a brace for a week and the other group will start moving in therapy right away.

Study Timeline

• Study Start: 2018-10-31
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-06-15
• Study Completion: 2026-08-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male and female adolescents between 11-17 years
• Medical diagnosis of 1st time lateral patellar instability episode (dislocation or subluxation)
• Subjective history of knee shifting, instability, popping out, knee effusion
• Apprehension test is positive and has medial patellar tenderness
• Referred to the Texas Children's Hospital (TCH) outpatient sports medicine clinic from an emergency room facility, urgent care or pediatrician within 10 days of the injury.
• Free of co-morbidities that would prevent or limit rehabilitation including cardiac, pulmonary, psychiatric (except Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD), orthopedic, neurological
• Must be able to follow directions and participate in rehabilitation protocol for the 3-month study period.

Exclusion Criteria

• Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immobilization	Early Range of MOtion	Patients in this group will be given a knee immobilizer to wear for 2 weeks and then receive outpatient physical therapy evaluation and treatment
Early range of motion	Early Range of MOtion	Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.

Primary Outcome Measures

Name	Time	Method
Isokinetic Strength using Biodex	30 minutes	Force of movement is measured in newtons and torque and corrected for body weight
Tegner Activity Scale	5 minutes	11 levels of activity from complete inability to function to advanced sports participation
Edema Assessment	2 minutes	Measure of knee circumference
Kujala Knee Score	10 minutes	13 item questionnaire to rate pain, function, ambulation, and instability
Passive Range of Motion	5 minutes	Measured with goniometer to record full range of motion in knee flexion and extension

Secondary Outcome Measures

Name	Time	Method
Numerical Pain Rating Scale	1 minute	Pain rated by patient on scale of 0-10.

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States