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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: University Hospital, Brest

Current Primary Outcome: Normal or abnormal hip ultrasound [ Time Frame: 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.


Original Primary Outcome:

  • Pubo-femoral distance (ultrasonographic measure). [ Time Frame: 2 months ]

    Pubo-femoral distance (ultrasonographic measure) is the distance between the pubic bone and the cartilaginous femoral head, considered as normal if lower than 6mm.

    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.

  • Bony rim percentage (ultrasonographic measure). [ Time Frame: 2 months ]

    Bony rim percentage (ultrasonographic measure) is the 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.



Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Brest

Dates:
Date Received: August 11, 2016
Date Started: December 8, 2016
Date Completion: December 2020
Last Updated: April 28, 2017
Last Verified: April 2017