Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children

NCT05009342 | Terminated

• 1 other identifier: 29BRC21.0016
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Injuries; Ligament Injury

Keywords

low-grade; osteo-ligament injuries; children; soft resin ankle brace; Below-knee rigid resin cast

Outcome Measures

Primary Outcomes (1)

• Activities Scale for Kids (ASKp)

  Activities Scale for Kids (ASKp) is a questionnaire about activities from the previous week. It has 30 item with 5 answers : all of the time (the better) / most of the time / sometimes / once in a while / none of the time (the worse).

  At 2 months

Secondary Outcomes (14)

• Visual Analogue Scale (VAS)

  day 0

• Visual Analogue Scale (VAS)

  day 21

• Numeric Scale (NS)

  day 0

• Numeric Scale (NS)

  day 21

• Clinical exams

  day 0

Study Arms (2)

Below-knee soft resin cast

EXPERIMENTAL

Below-knee soft resin cast is administered to participants in emergency department. Investigator puts three layers of jersey supplemented by strips of soft resins to be unrolled along the leg after immersion in warm water Duration to ankle immobilization with soft resin boot : 21 days.

Device: below-knee soft resin cast

Below-knee rigid resin cast

OTHER

Below-knee soft resin cast is administered to participants in emergency department. Investigator puts one layer of jersey and then one layer of foam composed by strips of cotton wool to be unrolled supplemented by strips of rigid resins to be unrolled along the leg after immersion in warm water. Duration to ankle immobilization with soft resin boot : 21 days.

Device: Below-knee rigid resin cast

Interventions

below-knee soft resin cast DEVICE

Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)

Below-knee soft resin cast

Below-knee rigid resin cast DEVICE

Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)

Below-knee rigid resin cast

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Walking child from 5 to 15 years old.
• From hour 0 to hour 48 of ankle trauma with torsion mechanism (inversion, eversion or rotation).
• Patient presenting for the first time to the emergency room for this traumatic episode.
• Possibility of carrying out an ultrasound during the passage to the emergency room.
• Child and parents' consent in the study participation

You may not qualify if:

• Pubescent patients requiring anticoagulation (menarche in girls and genital pilosity in boys).
• Direct shock on the foot without sprain mechanism.
• Fracture with deformation or open fracture.
• History of ankle trauma in the last 3 months.
• Neurological or neuromuscular pathology.
• Child with a delay in acquisitions and / or psychomotor development (difficulties in understanding and interacting to locate pain).
• Absence of a representative of parental authority.
• Constitutional bone disease or connective tissue.
• Acquired or congenital coagulopathy.
• Patient presenting beyond 48h of trauma.
• Polytraumatized.
• Dermabrasion, wound or sign of skin suffering next to the ankle requiring specific monitoring.
• Child or parents refusal in study participation

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, randomized, non-inferiority, without blinding, controlled trial with 2 parallel groups

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 17, 2021
• Study Start: September 9, 2021
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: March 4, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)