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

April 11, 2019 updated by: University Hospital, Brest

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Brest, France, 29609
        • Recruiting
        • CHRU de Brest
        • Contact:
          • Matthias THEPAUT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants who underwent ultrasonographic screening for developmental dysplasia of the hip and are adressed to a paediatric orthopaedic surgeon at Brest University Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 8, 2016

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (ESTIMATE)

September 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH (RB 16-057)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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