Trials / Terminated
TerminatedNCT05009342
Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University Hospital, Brest · Academic / Other
- Sex
- All
- Age
- 5 Years – 15 Years
- Healthy volunteers
- Not accepted
Summary
Lack of current consensus on the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children. Several types of immobilization are evaluated in the literature, with different conclusions. Some teams recommend a functional treatment similar to the adult (with or without strict immobilization), others remain on standard rigid immobilizations. The goal of the study is to simplify and homogenize the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children.
Detailed description
Lack of current consensus on the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children. Several types of immobilization are evaluated in the literature, with different conclusions. Some teams recommend a functional treatment similar to the adult (with or without strict immobilization), others remain on standard rigid immobilizations. The goal of the study is to simplify and homogenize the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children. CHEVIPED is a controlled, randomized, comparative monocentric trial. Randomization into 2 groups and stratified on presence to fracture Salter 1 and age Experimental group : Patients with below-knee soft resin cast Control group : Patients with below-knee rigid resin cast. The primary objective is to demonstrate at 2 months that with post traumatic low- grade osteo-ligamentous ankle injury the recovery of physical function are at least as effective with a below-knee soft resin cast compared to a below-knee rigid resin cast. The secondary objectives are : 1. Clinical evaluation of treatment at 3 weeks in immediate post-immobilization. 2. Evaluation of the management satisfaction (effectiveness and understanding) and the treatment tolerance . 3. Evaluation of the time taken to resume painless support after immobilization. 4. Point of interest evaluation 5. Determine the diagnostic performance of the "combined clinical criteria" in comparison with the ultrasound/radiography couple. 6. Evaluation of the diagnostic performance of clinical inspection criteria (edema, bruise) in high-grade ligament damage. 7. Evaluation of the link between the "combined clinical criteria" and the results of the radiography. 8. Evaluation of the relationship between "combined clinical criteria" and ultrasound results. 9. Evaluation of the link between the results of radiography and ultrasound. 200 patients are expected to be included. Inclusion period : 12 months. Duration of patient's participation: 2 months Total study duration: 14 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | below-knee soft resin cast | Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1) |
| DEVICE | Below-knee rigid resin cast | Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1) |
Timeline
- Start date
- 2021-09-09
- Primary completion
- 2023-06-09
- Completion
- 2023-06-09
- First posted
- 2021-08-17
- Last updated
- 2024-03-04
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05009342. Inclusion in this directory is not an endorsement.