abnormal hip development hip dysplasia
Conditions
Interventions
use of the Pavlik harness (abduction treatment)
Sponsors
Universiteit Maastricht
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
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
Exclusion criteria: -hip instability -(suspicion of) syndromal disease -prematurity (defined as a gestational age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| active monitoring of infants with stable centered DDH (Graf type IIa-/IIb/IIc) does not result in a lower proportion of infants with normal hips (success: acetabular index lower than 25 degrees on radiograph) at the age of 12 months compared to abduction treatment (a non-inferiority study). | — |
Secondary
| Measure | Time frame |
|---|---|
| - What is the difference in success rate between both study groups at the age of 24 months? - Do fewer complications occur when infants are treated with active monitoring compared to treatment with a dynamic abduction device? - What is the difference in time to Graf I? - Which factors are associated with the outcome at 12 and 24 months? - Are parents compliant to the abduction device? - Is treatment with active monitoring cost effective to treatment with a dynamic abduction device? - What is the quality of life of the infants and of the parents? - Is parent-satisfaction different between both treatment options? | — |
Countries
Netherlands
Outcome results
None listed