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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 2 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
BC Children's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Emily Schaeffer, PhD
emily.schaeffer@cw.bc.ca
604-875-2359
Backup
Bryn Zomar, PhD
bryn.zomar@cw.bc.ca
604-875-2359
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2028-09
Participants
Target number of participants: 514
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov