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

Sponsor
University Hospital, Brest (Other)
Overall Status
Unknown status
CT.gov ID
NCT02885831
Collaborator
(none)
90
Enrollment
1
Location
59.8
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Abduction splintage

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip : Improvement or Overtreatment ?
Actual Study Start Date :
Dec 8, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
A - Abduction splintage

Treatment by abduction splintage. Sonographic, clinical and radiographic surveillance. 45 patients.

Device: Abduction splintage
Treatment by abduction splintage 24 hours a day and 7 days a week, for 2 months.
Other Names:
  • Neut Supple Hip Abduction Cushion Without Bone

    		•
    B - Surveillance

    No treatment by abduction splintage. Sonographic, clinical and radiographic surveillance. 45 patients

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 2 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    • Principal Investigator: Matthias THEPAUT, PhD, University Hospital, Brest

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT02885831
    Other Study ID Numbers:
    • BBH (RB 16-057)
    First Posted:
    Sep 1, 2016
    Last Update Posted:
    Apr 12, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by University Hospital, Brest
    Abduction splint
    Pubo-femoral distance
    Additional relevant MeSH terms:
    Hip Dislocation
    Developmental Dysplasia of the Hip
    Hip Dislocation, Congenital

    Study Results

    No Results Posted as of Apr 12, 2019