Clinical trial NCT05869851: Developmental Dysplasia of the Hip: Observation Vs. Bracing
Official title: Comparison of Brace to Observation in Stable, Radiological Developmental Dysplasia of the Hip: a Multi-centre, International Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Hip Dysplasia
Hip Dysplasia, Congenital
Hip Dysplasia, Developmental
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 514
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Early detection of developmental dysplasia of the hip (DDH) is critical to optimize outcomes and minimize long-term disability and impact on quality of life for the child and family. The burden of disease is significant, with a DDH diagnosis in 15-20/1000 live births. Even when treated, DDH is a leading cause of early hip replacement or development of osteoarthritis in young adults, with DDH reportedly accounting for 10-92% of all hip replacements. Consideration must also be given, however, to potential overtreatment of infants, particularly in more mild cases of hip instability or radiological dysplasia. The hip joint is immature during infancy, and many cases of mild-to-moderate DDH can spontaneously resolve as the hip joint matures through development. Brace treatment for approximately six weeks is common to address this radiological dysplasia; however, it is unclear whether this approach provides significant benefit above careful observation by ultrasound. While a conservative, less costly approach, brace treatment is not without potential complications and drawbacks. There are still substantial healthcare costs and resources associated with brace treatment, but there is potentially an under-recognized psychosocial cost in regard to preventing or disrupting mother-infant bonding in the newborn period. Coping with the difficulties of brace treatment can be stressful for families, particularly mothers of newborns, but the ultimate psychosocial impact has been under-researched to date. There is evidence to suggest that events occurring during establishment of breastfeeding may impact the mother's ability to breastfeed. The UK Hip Trial (2005) also found that maternal anxiety and worries about their infant's hip were increased with early brace treatment, but were not elevated by ultrasound monitoring in isolation. Further, bracing can present challenges to daily family life, including dressing, mobility, and the need for specialized furniture, car seats and other equipment. 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.

The investigators propose to utilize the existing collaborations and infrastructure of the Global Hip Dysplasia Registry (GHDR) and leverage their collaboration with a group in the Netherlands performing a similar Treatment with Active Monitoring (TRAM) trial to determine whether observation alone is sufficient for infants with clinically stable radiologically abnormal hips. Specifically, the investigators aim to:

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)

This study will utilize the established infrastructure of the GHDR. GHDR was established in 2016, aimed at collecting longitudinal data on infants and children across the entire DDH spectrum. This specific trial will function as a targeted sub-study within the more extensive registry, and is a multi-centre, international prospective randomized non-inferiority trial designed to evaluate the necessity to treat infants with radiological hip dysplasia. In total, 14 of the centres currently contributing data to GHDR have agreed to participate and randomize eligible patients.

Eligibility 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

Primary outcomes:
measure: Acetabular Index
timeFrame: 2 years
Secondary outcomes:
measure: Alpha Angle
timeFrame: 6 weeks
measure: Beta Angle
timeFrame: 6 weeks
measure: Percent Femoral Head Coverage
timeFrame: 6 weeks
measure: Number of Participants that Experienced Complications
timeFrame: 2 years
measure: Parent/Guardian Perception Questionnaire
timeFrame: 6 weeks
measure: EuroQoL-5D
timeFrame: 6 weeks, 1 year, 2 years
measure: Parent/Guardian Satisfaction
timeFrame: 6 weeks, 1 year, 2 years
measure: Healthcare Resource Use Questionnaire
timeFrame: 6 weeks, 6 months, 1 year, 18 months, 2 years (Canadian centres only)
Other outcomes:
measure: Centre Edge Angle
timeFrame: 5 years
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kishore Mulpuri, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Emily Schaeffer, PhD
role: STUDY_DIRECTOR
References: