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NCT02885831 Clinical Trial

Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip

Congenital Hip Dysplasia Clinical Trial

— BBH  

Official title:
Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip : Improvement or Overtreatment ?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02885831
Other study ID # BBH (RB 16-057)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 8, 2016
Est. completion date December 2021

Study information
Verified date April 2019
Source University Hospital, Brest
Contact Matthias THEPAUT, PhD
Phone 0033298223926
Email matthias.thepaut@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to prove the improvement of pubo-femoral distance by early abduction splintage in one-month-old infants with developmental dysplasia of the hip (with a clinical stable hip but an abnormal hip ultrasonography).

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 1 Month to 2 Months
Eligibility Inclusion Criteria:

- Term infants

- Infants between 1 and 2 months of age at inclusion

- Clinically stable hip

- Pathological ultrasonography : pubo-femoral distance >6mm and bony rim percentage <50%

- Non objection of the family

Exclusion Criteria:

- Clinically unstable hip

- Normal ultrasonography

- Neuro-orthopedic disease

- Postural deformity of the pelvis

- Participation refusal

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Abduction splintage
Treatment by abduction splintage 24 hours a day and 7 days a week, for 2 months.

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Normal or abnormal hip ultrasound A normal or abnormal hip ultrasound will be base on two outcomes :
Pubo-femoral distance (ultrasonographic measurement) : distance between the pubic bone and the cartilaginous femoral head, considered as normal if lower than 6mm.
Bony rim percentage (ultrasonographic measurement) : percentage of the cartilaginous femoral head covered by the acetabular roof, considered as normal if higher than 50% (or equal to 50%).
Data of pubo-femoral distance and bony rim percentage will be pooled to determine if the ultrasound is normal or not for each patient. If one out of two is abnormal, ultrasound is considered abnormal. Statistics will be based on this qualitative value : normal or abnormal ultrasound.		 2 months
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