Congenital Hip DysplasiaBBHNCT02885831
Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip
An observational study of Congenital Hip Dysplasia, run by University Hospital, Brest at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 month to 2 months
- Conditions the study is for
- Congenital Hip Dysplasia
- What is being tested?
- Abduction splintage
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2016to 17 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Clinically unstable hip
- Normal ultrasonography
- Neuro-orthopedic disease
- Postural deformity of the pelvis
- Participation refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Congenital Hip Dysplasia
- Being tested
- Abduction splintage
- Keywords
- Abduction splint, Pubo-femoral distance
- Medical subject headings
- Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abduction splintageDevice
Also called Neut Supple Hip Abduction Cushion Without Bone
Treatment by abduction splintage 24 hours a day and 7 days a week, for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| A - Abduction splintage | Treatment by abduction splintage. Sonographic, clinical and radiographic surveillance. 45 patients. Receives: Device: Abduction splintage | |
| B - Surveillance | No treatment by abduction splintage. Sonographic, clinical and radiographic surveillance. 45 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start8 Dec 2016
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Hip DysplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias THEPAUT, PhD, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885831
- Sponsor's protocol ID
- 29BRC17.0021
- Acronym
- BBH
- Status last verified
- Jun 2026
- First submitted
- 11 Aug 2016
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36214650
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip : Improvement or Overtreatment ?
- ClinicalTrials.gov ID
- NCT02885831
- Acronym / sponsor ID
- BBH / 29BRC17.0021
- Conditions
- Congenital Hip Dysplasia
- Keywords
- Abduction splint, Pubo-femoral distance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Abduction splintage | – | Device: Abduction splintageTreatment by abduction splintage. Sonographic, clinical and radiographic surveillance. 45 patients. |
| B - Surveillance | – | –No treatment by abduction splintage. Sonographic, clinical and radiographic surveillance. 45 patients |
Who may qualify
- Ages
- 1 month to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Clinically unstable hip
- Normal ultrasonography
- Neuro-orthopedic disease
- Postural deformity of the pelvis
- Participation refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abduction splintageAlso: Neut Supple Hip Abduction Cushion Without BoneTreatment by abduction splintage 24 hours a day and 7 days a week, for 2 months. | Device | A - Abduction splintage |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 36214650Dwan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias THEPAUT, PhD principal investigator
University Hospital, Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hip Dysplasia, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal or abnormal hip ultrasound (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02885831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.