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Completed

NCT Number: NCT02885831

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

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).

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Key information

Conditions

Congenital Hip Dysplasia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Hip Dislocation, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

1 month–2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abduction splintage

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: BBH

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2016
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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