Active monitoring versus an abduction device for treatment of infants with centered dysplastic hips: a RCT. TReatment with Active Monitoring (TRAM-Trial)
Recruiting
- Conditions
- abnormal hip developmenthip dysplasia10028396
- Registration Number
- NL-OMON56369
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
- patients with Graf 2a- or 2b or 2c DDH
-10-20 weeks old
-good command of the dutch language of the parents
-parental informed consent
Exclusion Criteria
-hip instability
-(suspicion of) syndromal disease
-prematurity (defined as a gestational age < 37 weeks)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>active monitoring of infants with stable centered DDH (Graf type IIa-/IIb/IIc)<br /><br>does not result in a lower proportion of infants with normal hips (success:<br /><br>acetabular index lower than 25 degrees on radiograph) at the age of 12 months<br /><br>compared to abduction treatment (a non-inferiority study). </p><br>
- Secondary Outcome Measures
Name Time Method <p>- What is the difference in success rate between both study groups at the age<br /><br>of 24 months?<br /><br>- Do fewer complications occur when infants are treated with active monitoring<br /><br>compared to treatment with a dynamic abduction device?<br /><br>- What is the difference in time to Graf I?<br /><br>- Which factors are associated with the outcome at 12 and 24 months?<br /><br>- Are parents compliant to the abduction device?<br /><br>- Is treatment with active monitoring cost effective to treatment with a<br /><br>dynamic abduction device?<br /><br>- What is the quality of life of the infants and of the parents?<br /><br>- Is parent-satisfaction different between both treatment options?</p><br>