Clinical trial Recruiting at 1 site Interventional Ages Any age to 12 Weeks

Comparing observation and bracing for mild hip dysplasia in infants

Official title: Comparison of Brace to Observation in Stable, Radiological Developmental Dysplasia of the Hip: A Multi-centre, International Randomized Controlled Non-inferiority Trial

Run by University of British Columbia · NCT05869851 · Data updated 2026-11-12

This study tests if watching and monitoring infants with mild hip dysplasia is just as good as using braces to help them, to see if we can avoid unnecessary treatments.

Quick facts

Study typeInterventional
AgesAny age to 12 Weeks
SexAll
Enrollment514 (estimated)
SponsorUniversity of British Columbia
Academic / other
Locations1 site (Vancouver, British Columbia)
StatusRecruiting
StartedApril 25, 2024
Main results expectedSeptember 2027
Study endsSeptember 2028
Registry record updatedNovember 24, 2025
Trial IDNCT05869851 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants under three months of age with radiological dysplasia of a clinically stable hip.

Probably not a fit

Patients older than three months or those with clinical hip instability or other congenital abnormalities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether careful monitoring can be as effective as bracing for infants diagnosed with mild developmental dysplasia of the hip (DDH) under three months of age. By comparing outcomes between these two approaches, the research aims to determine if unnecessary treatment can be avoided, thereby reducing potential complications and psychosocial impacts on families. The study will involve infants from various hospitals across seven countries, making it a significant international effort to improve care for this common childhood condition.

Why it matters

Potential benefit: If successful, this study could lead to more effective and less invasive treatment options for infants with mild DDH, enhancing family bonding and reducing healthcare costs.

How similar studies have gone: While this approach of careful observation has been suggested in previous studies, this is the first large-scale investigation to directly compare it with bracing in infants with mild DDH.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • BC Children's Hospital
    Vancouver, British Columbia, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.