Active Monitoring versus an Abduction Device for treatment of Infants with Centered Dysplastic Hips, a RCT(TReatment with Active Monitoring (TRAM)-Trial)
- Conditions
- Stable centered Developmental Dysplasia of the Hip (DDH)
- Registration Number
- NL-OMON29596
- Lead Sponsor
- Maastricht University
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
In order to be eligible for participation in this study, a subject must meet all of the following criteria:
Graf IIb or IIc DDH, diagnosed with ultrasound; Age 10-16 weeks; In case of a bilateral DDH, the hip with the worst Graf classification will be included; Good command of Dutch language of the parents; Parental informed consent
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: Hip instability; Age <10 weeks or >16 weeks; (Suspicion of) syndromal disease (e.g. arthrogryposis, cerebral palsy, Down syndrome); Prematurity (defined as a gestational age <37 weeks).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acetabular index at the age of 12 months
- Secondary Outcome Measures
Name Time Method Acetabular index at the age of 24 months<br>Complications <br>Time to achieve a normal hip<br>Factors associated with outcome at 12 and 24 months<br>Compliance of the parents<br>Costs, cost-effectiveness and budget impact<br>Health-related quality of life of infants and parents<br>Parent-satisfaction