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

NCT ID: NCT02885831

Last Updated: 2019-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-08

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Hip Dysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A - Abduction splintage

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

Abduction splintage

Intervention Type DEVICE

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

B - Surveillance

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abduction splintage

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neut Supple Hip Abduction Cushion Without Bone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthias THEPAUT, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Brest

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU de Brest

Brest, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Matthias THEPAUT, PhD

Role: CONTACT

0033298223926

Camille PRINTEMPS, Resident

Role: CONTACT

0033238223926

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Matthias THEPAUT

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36214650 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BBH (RB 16-057)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Movement-based Infant Intervention
NCT03082313 COMPLETED NA
Use of Dynamic Elastometric Body in Preterm Newborns
NCT05835765 ENROLLING_BY_INVITATION NA