Intraarticular Corticosteroid Therapy in Perthes Disease.
Stopped: low recruitment
United States3 participantsStarted 2009-03
Plain-language summary
Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. This study represents a single center, randomized, prospective, controlled study comparing the treatment of LCP with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment.
Who can participate
Age range
4 Years – 13 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:
* age of 4 to 12 years
* diagnosed with Idiopathic osteonecrosis of the femoral head
* symptoms less than 12 months old.
Exclusion Criteria:
* Symptoms for more than 12 months
* Previous treatment other than anti-inflammatories, crutches or bed rest
* Subjects more than 8 years old or have a hand bone age greater than 6 years old and lateral pillar B or B/C disease.
* Bilateral hip disease
* Personal or family history of problems with general anesthesia
* Prior steroid treatment
* Previous diagnosis of:
* Asthma
* Identifiable rheumatologic condition
* Metabolic Diseases (including but not limited to Gaucher's disease or congenital hypothyroidism)
* Sickle cell disease
* Known pain syndrome
* Hip sepsis
* Prior malignancy (solid organ or bone marrow transplant)
* Blood Clotting disorder
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
1
Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.
Timeframe: This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.