Brace RCT vs DDH Observation
Research type
Research Study
Full title
Comparison of brace to observation in stable, radiological developmental dysplasia of the hip: A multi-centre, international randomized controlled non-inferiority trial
IRAS ID
356159
Contact name
Alexander Aarvold
Contact email
Sponsor organisation
University Hospital Southampton NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 20 days
Research summary
Developmental dysplasia of the hip (DDH) is the most common paediatric hip disorder, affecting an estimated 1-3% of all infants.1 DDH represents many disorders, ranging in severity from mild dysplasia in a clinically stable hip, to complete hip dislocation. If left undetected or untreated, it can lead to devastating complications later in life.
Brace treatment in infancy is common to address radiological dysplasia; however, it is unclear whether this approach provides significant benefit above careful observation by ultrasound (and intervening with treatment if necessary). If observation alone is non-inferior to bracing for radiological dysplasia, unnecessary treatment may be avoided, potentially decreasing both the psychosocial impact of disrupted mother-infant bonding and needed healthcare resources and costs.
Objectives:
1. Determine whether observation is non-inferior to bracing for infants with radiological dysplasia
2. Provide a strong recommendation for management of this subset of DDH patients
3. Compare findings to those of the Netherlands trial, which is being carried out in older patients (10-16 weeks at diagnosis)15 of the centres currently contributing data to Global Hip Dysplasia Registry have agreed to participate and randomise eligible patients.
Each site will collect and enter de-identified data into the REDCap database managed by GHDR host site British Columbia Children’s Hospital (BCCH) with assistance from a coordinator based at SickKids in Toronto.
Throughout the trial, patients in the observation arm will be closely monitored to determine if they need to crossover to the brace treatment arm. If radiological parameters have deteriorated at the six-week ultrasound, brace treatment will be initiated and maintained as necessary.Observational Data:
Those patients choosing not to enroll in the trial will still be followed up for the outcomes listed above where possible and be included as an observational cohort.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
25/SC/0393
Date of REC Opinion
19 Dec 2025
REC opinion
Favourable Opinion