Effect of Early Range of Motion Following First Time Patellar Dislocation

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

Detailed Description
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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.

Official Title
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Effect of Early Range of Motion on Recovery in Individuals Following First Time Patellar

Conditions
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Patellar Dislocation

Intervention / Treatment
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* Other: Early Range of MOtion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dual-arm randomized intervention comparison study evaluation two rehabilitation protocols for individuals following a first time lateral patella instability episode.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immobilization<br>Patients in this group will be given a knee immobilizer to wear for 2 weeks and then receive outpatient physical therapy evaluation and treatment | Other: Early Range of MOtion<br>* Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.<br>* Other names: Ear;y Range of Motion;|
| Experimental: Early range of motion<br>Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately. | Other: Early Range of MOtion<br>* Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.<br>* Other names: Ear;y Range of Motion;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Rating Scale | Pain rated by patient on scale of 0-10. | 1 minute |