---
title: Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip
nct_id: NCT02885831
overall_status: UNKNOWN
sponsor: University Hospital, Brest
study_type: OBSERVATIONAL
primary_condition: Congenital Hip Dysplasia
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02885831.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02885831"
ct_last_update_post_date: 2019-04-12
last_seen_at: "2026-05-12T06:24:39.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip

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

**NCT ID:** [NCT02885831](https://clinicaltrials.gov/study/NCT02885831)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** University Hospital, Brest
- **Conditions:** Congenital Hip Dysplasia
- **Start Date:** 2016-12-08
- **Completion Date:** 2021-12
- **CT.gov Last Update:** 2019-04-12

## 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).

## Eligibility

- **Minimum age:** 1 Month
- **Maximum age:** 2 Months
- **Sex:** ALL
- **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
```

## Arms

- **A - Abduction splintage** — Treatment by abduction splintage. Sonographic, clinical and radiographic surveillance. 45 patients.
- **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.

## Primary Outcomes

- **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.

## Locations (1)

- CHRU de Brest, Brest, France — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chru de brest|brest||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02885831.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02885831*  
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