Recruiting

Observation vs. Bracing

Sponsor:

University of British Columbia

Code:

NCT05869851

Conditions

Developmental Dysplasia of the Hip

Hip Dysplasia

Hip Dysplasia, Congenital

Hip Dysplasia, Developmental

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Pavlik Harness

Study Details

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.

Conditions

Developmental Dysplasia of the Hip

Hip Dysplasia

Hip Dysplasia, Congenital

Hip Dysplasia, Developmental

Study ID

NCT05869851

Start date

Apr 25, 2024

Status verified date

Nov, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

514 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brace Treatment

Patients randomized to the brace treatment group will be treated with a Pavlik harness for a minimum of six weeks.

no intervention: Active Monitoring

Patients randomized to the control group will undergo observation only.

Interventions

Pavlik Harness

The Pavlik harness is an abduction brace used for treatment of hip dysplasia in infants. It keeps the hips in proper alignment to allow for appropriate growth and development of the joint.

Primary outcome measure

  • Acetabular Index [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Emily Schaeffer, PhD

604-875-2359emily.schaeffer@cw.bc.ca

Bryn Zomar, PhD

604-875-2359bryn.zomar@cw.bc.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H3N1

Contacts

Emily Schaeffer, PhD

604-875-2359emily.schaeffer@cw.bc.ca

Principal Investigator:

Kishore Mulpuri, FRCSC

More Information

Sponsor

University of British Columbia

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-11-24.