Developmental Dysplasia of the Hip: Observation vs. Bracing (NCT05869851) | Clinical Trial Compass
RecruitingNot Applicable
Developmental Dysplasia of the Hip: Observation vs. Bracing
Canada514 participantsStarted 2024-04-25
Plain-language summary
Developmental dysplasia of the hip (DDH) is the most common childhood hip condition. When caught early, bracing is the most frequently used treatment; however, the brace can disrupt important mother-baby bonding time in the newborn period and present challenges to daily living. In babies with mild DDH, some studies have suggested that their hips may improve naturally as they grow and develop. This study will look at whether careful monitoring can be just as good as bracing for babies diagnosed with mild DDH less than 3 months of age, potentially avoiding unnecessary treatment. This will be the first study to look at this question with babies being treated at different hospitals in seven different countries, so the results will make an impact on children and families worldwide.
Who can participate
Age range
12 Weeks
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:
* Patients presenting with radiological dysplasia of a clinically stable hip under three months (12 weeks) of age
* Radiological dysplasia will be defined as a centred hip with an alpha angle between 43 and 60 degrees and a percent coverage of the femoral head (FHC) greater than 35%, as measured on ultrasound exam
Exclusion Criteria:
* Patients presenting with radiological dysplasia older than three months (12 weeks) of age
* Patients presenting with clinical hip instability (Ortolani or Barlow positive)
* Patients with known or suspected neuromuscular, collagen, chromosomal or lower-extremity congenital abnormalities or syndromic-associated hip abnormalities
* Patients who received prior treatment (i.e. Pavlik harness) for DDH
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.