NCT05869851 Developmental Dysplasia of the Hip: Observation vs. Bracing
| NCT ID | NCT05869851 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Developmental Dysplasia of the Hip |
| Study Type | INTERVENTIONAL |
| Enrollment | 514 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 514 participants in total. It began in 2024-04-25 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Kishore Mulpuri, FRCSC
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05869851 clinical trial?
This trial is open to participants of all sexes, up to 12 Weeks, studying Developmental Dysplasia of the Hip. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05869851 currently recruiting?
Yes, NCT05869851 is actively recruiting participants. Contact the research team at emily.schaeffer@cw.bc.ca for enrollment information.
Where is the NCT05869851 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05869851 clinical trial?
NCT05869851 is sponsored by University of British Columbia. The principal investigator is Kishore Mulpuri, FRCSC at University of British Columbia. The trial plans to enroll 514 participants.