Developmental Dysplasia of the Hip: Observation vs. Bracing

NCT05869851 | Recruiting DMC

• 1 other identifier: H20-03750
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Acetabular Index

  A measure of the steepness of the acetabular roof assessed on radiograph.

  2 years

Secondary Outcomes (8)

• Alpha Angle

  6 weeks

• Beta Angle

  6 weeks

• Percent Femoral Head Coverage

  6 weeks

• Number of Participants that Experienced Complications

  2 years

• Parent/Guardian Perception Questionnaire

  6 weeks

Other Outcomes (1)

• Centre Edge Angle

  5 years

Study Arms (2)

Brace Treatment

EXPERIMENTAL

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

Other: Pavlik Harness

Active Monitoring

NO INTERVENTION

Patients randomized to the control group will undergo observation only.

Interventions

Pavlik Harness OTHER

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.

Brace Treatment

Eligibility Criteria

• Age: Up to 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H3N1, Canada

RECRUITING

Related Publications (1)

• Zomar BO, Bone JN, Nguyen V, Mulpuri K, Kelley S; GHD Study Group; Schaeffer EK. Comparison of brace to observation in stable, radiological developmental dysplasia of the hip: a protocol for a global multicentre non-inferiority randomised trial. BMJ Open. 2024 Jul 8;14(7):e084738. doi: 10.1136/bmjopen-2024-084738.

  PMID: 38977361 DERIVED

MeSH Terms

Conditions

Developmental Dysplasia of the Hip; Hip Dislocation; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries; Hip Injuries

Study Officials

• Kishore Mulpuri, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Emily Schaeffer, PhD

  University of British Columbia

  STUDY DIRECTOR

Central Study Contacts

Emily Schaeffer, PhD

CONTACT

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

Bryn Zomar, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 22, 2023
• Study Start: April 25, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)