Active — Not RecruitingNot Applicable

Effect of Early Range of Motion Following First Time Patellar Dislocation

United States60 participantsStarted 2018-10-31

Plain-language summary

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

Who can participate

Age range

11 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Kujala Knee Score

Timeframe: 10 minutes

Tegner Activity Scale

Timeframe: 5 minutes

Isokinetic Strength using Biodex

Timeframe: 30 minutes

Passive Range of Motion

Timeframe: 5 minutes

Edema Assessment

Timeframe: 2 minutes

Trial details

NCT IDNCT04294199

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-15

View on ClinicalTrials.gov More Patellar Dislocation trials

Who can participate

Age range

11 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.