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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02885831
Acronym
BBH
Enrollment
90
Registered
2016-09-01
Start date
2016-12-08
Completion date
2023-01-17
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Hip Dysplasia

Keywords

Abduction splint, Pubo-femoral distance

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).

Interventions

DEVICEAbduction splintage

Treatment by abduction splintage 24 hours a day and 7 days a week, for 2 months.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 2 Months
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

Design outcomes

Primary

MeasureTime frameDescription
Normal or abnormal hip ultrasound2 monthsA 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMatthias THEPAUT, PhD

University Hospital, Brest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026