Related Experiment Video
Updated: Aug 1, 2025
In Vivo Quantification of Hip Arthrokinematics during Dynamic Weight-bearing Activities using Dual Fluoroscopy
Published on: July 2, 2021
Active monitoring versus an abduction device for treatment of infants with centered dysplastic hips: study protocol
Frederike E C M Mulder1, M Adhiambo Witlox2, Carmen D Dirksen3
1Department of Orthopedic Surgery, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands. fecm.mulder@maastrichtuniversity.nl.
Insights
This study compares active monitoring to abduction treatment for infants with centered Developmental Dysplasia of the Hip (DDH). It assesses cost-effectiveness to improve pediatric orthopedic care.
Area of Science:
- Pediatric Orthopedics
- Developmental Dysplasia of the Hip (DDH)
- Clinical Trials
Background:
- Developmental Dysplasia of the Hip (DDH) is a common pediatric orthopedic condition affecting 1-3% of newborns.
- Optimal treatment for centered DDH remains under debate.
- This study addresses the need for evidence on the (cost-)effectiveness of different management strategies.
Purpose of the Study:
- To compare the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH.
- To evaluate secondary outcomes including complications, time to normalization, and health-related quality of life.
- To inform current care-as-usual for DDH management.
Main Methods:
- A multicenter, parallel-group, open-label, non-inferiority randomized controlled trial.
- 800 infants (aged 10-16 weeks) with centered DDH (Graf IIa-/IIb/IIc) were randomized to active monitoring or abduction treatment.
- Follow-up until 24 months, with primary outcome of normal hips at 12 months (acetabular index < 25 degrees).
Main Results:
- Primary outcome: Rate of normal hips at 12 months.
- Secondary outcomes: Normal hips at 24 months, complications, time to normalization, costs, cost-effectiveness, HRQoL, and parent satisfaction.
- Analysis of baseline patient characteristics' impact on hip normalization.
Conclusions:
- Outcomes will guide optimal treatment strategies for centered DDH.
- This trial aims to enhance care for infants diagnosed with DDH.
- Evidence generated will support clinical decision-making in pediatric hip dysplasia management.
Background:
Developmental Dysplasia of the Hip (DDH) is one of the most common pediatric orthopedic disorders, affecting 1-3% of all newborns. The optimal treatment of centered DDH is currently under debate. This randomized controlled trial aims to study the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH.
Methods:
This is a multicenter, parallel-group, open-label, non-inferiority randomized controlled trial studying the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH in fourteen hospitals in the Netherlands. In total, 800 infants with centered DDH (Graf IIa-/IIb/IIc), aged 10-16 weeks, will be randomly allocated to the active monitoring or abduction treatment group. Infants will be followed up until the age of 24 months. The primary outcome is the rate of normal hips, defined as an acetabular index lower than 25 degrees on an antero-posterior radiograph, at the age of 12 months. Secondary outcomes are the rate of normal hips at the age of 24 months, complications, time to hip normalization, the relation between baseline patient characteristics and the rate of normal hips, compliance, costs, cost-effectiveness, budget impact, health-related quality of life (HRQoL) of the infant, HRQoL of the parents/caregivers, and parent/caregiver satisfaction with the treatment protocol.
Discussion:
The outcomes of this randomized controlled trial will contribute to improving current care-as-usual for infants with centered DDH.
Trial Registration:
Dutch Trial Register, NL9714, registered September 6, 2021. https://clinicaltrialregister.nl/en/trial/29596.
More Related Videos
09:51The Transition to an Anterior-Based Muscle Sparing Approach Improves Early Postoperative Function but is Associated with a Learning Curve
Published on: September 7, 2022
07:11Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling
Published on: February 5, 2019