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

• Conditions: Congenital Hip Dysplasia
• Interventions: Device: Abduction splintage

• Registration Number: NCT02885831
• Lead Sponsor: University Hospital, Brest

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-09-01
• Study Start: 2016-12-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-12
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A - Abduction splintage	Abduction splintage	Treatment by abduction splintage. Sonographic, clinical and radiographic surveillance. 45 patients.

Primary Outcome Measures

Name	Time	Method
Normal or abnormal hip ultrasound	2 months	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.

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France