Skip to content

Active Monitoring versus an Abduction Device for treatment of Infants with Centered Dysplastic Hips, a RCT (TReatment with Active Monitoring (TRAM)-Trial)

Active Monitoring versus an Abduction Device for treatment of Infants with Centered Dysplastic Hips, a RCT (TReatment with Active Monitoring (TRAM)-Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29596
Enrollment
800
Registered
2021-09-06
Start date
2021-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable centered Developmental Dysplasia of the Hip (DDH)

Interventions

Active monitoring: Active monitoring: patients will not receive an abduction device. Patients will receive ultrasound monitoring every 6 weeks and physical examination, until: 1. full recovery of the

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Hip instability; Age 16 weeks; (Suspicion of) syndromal disease (e.g. arthrogryposis, cerebral palsy, Down syndrome); Prematurity (defined as a gestational age <37 weeks).

Design outcomes

Primary

MeasureTime frame
Acetabular index at the age of 12 months

Secondary

MeasureTime frame
Acetabular index at the age of 24 months Complications Time to achieve a normal hip Factors associated with outcome at 12 and 24 months Compliance of the parents Costs, cost-effectiveness and budget impact Health-related quality of life of infants and parents Parent-satisfaction

Contacts

Public ContactFrederike Mulder

Maastricht University

fecm.mulder@maastrichtuniversity.nl043 – 387 7144

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)