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

NCT02885831 | Unknown

• 1 other identifier: BBH (RB 16-057)
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Congenital Hip Dysplasia

Keywords

Abduction splint; Pubo-femoral distance

Outcome Measures

Primary Outcomes (1)

• Normal or abnormal hip ultrasound

  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

Study Arms (2)

A - Abduction splintage

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

Device: Abduction splintage

B - Surveillance

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

Interventions

Abduction splintage DEVICE

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

Also known as: Neut Supple Hip Abduction Cushion Without Bone

A - Abduction splintage

Eligibility Criteria

• Age: 1 Month - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Term infants
• Clinically stable hip
• Pathological ultrasonography : pubo-femoral distance \>6mm and bony rim percentage \<50%
• Non objection of the family

You may not qualify if:

• Clinically unstable hip
• Normal ultrasonography
• Neuro-orthopedic disease
• Postural deformity of the pelvis
• Participation refusal

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Related Publications (1)

• Dwan K, Kirkham J, Paton RW, Morley E, Newton AW, Perry DC. Splinting for the non-operative management of developmental dysplasia of the hip (DDH) in children under six months of age. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD012717. doi: 10.1002/14651858.CD012717.pub2.

  PMID: 36214650 DERIVED

MeSH Terms

Conditions

Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthias THEPAUT, PhD

  University Hospital, Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias THEPAUT, PhD

CONTACT

0033298223926; matthias.thepaut@chu-brest.fr

Camille PRINTEMPS, Resident

CONTACT

0033238223926; camille.printemps@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 1, 2016
• Study Start: December 8, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

FR (1)