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OpenTrials
Active, Not Recruiting

NCT Number: NCT04294199

Effect of Early Range of Motion Following First Time Patellar Dislocation

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early Range of MOtion

Other

Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.

Other names: Immobilization, Ear;y Range of Motion

Primary outcomes

  1. Kujala Knee Score

    Time frame: 10 minutes

    13 item questionnaire to rate pain, function, ambulation, and instability

  2. Tegner Activity Scale

    Time frame: 5 minutes

    11 levels of activity from complete inability to function to advanced sports participation

  3. Isokinetic Strength using Biodex

    Time frame: 30 minutes

    Force of movement is measured in newtons and torque and corrected for body weight

  4. Passive Range of Motion

    Time frame: 5 minutes

    Measured with goniometer to record full range of motion in knee flexion and extension

  5. Edema Assessment

    Time frame: 2 minutes

    Measure of knee circumference

Secondary outcomes

  1. Numerical Pain Rating Scale

    Time frame: 1 minute

    Pain rated by patient on scale of 0-10.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Mar 4, 2020
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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