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

Ankle Injuries Clinical Trial

— CHEVIPED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05009342
• Other study ID #: 29BRC21.0016
• Status: Terminated
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: June 9, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 9, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ankle Injuries
• Ligament Injury
• Wounds and Injuries

Intervention

Device:
• below-knee soft resin cast
Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)
• Below-knee rigid resin cast
Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)

Locations

Country	Name	City	State
France	CHU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Scale (VAS)	It is a scale that measures pain intensity with small ruler, between 0 (no pain) to 10 (severe pain). It can be administered for children 4 to 6 years old.	day 0
Secondary	Visual Analogue Scale (VAS)	It is a scale that measures pain intensity with small ruler, between 0 (no pain) to 10 (severe pain). It can be administered for children 4 to 6 years old.	day 21
Secondary	Numeric Scale (NS)	It is a scale that mesures pain intensity. Children aged to 4 to 6 years gives a grade between 0 (no pain) to 10 (severe pain)	day 0
Secondary	Numeric Scale (NS)	It is a scale that measures pain intensity. Children aged to 4 to 6 years gives a grade between 0 (no pain) to 10 (severe pain)	day 21
Secondary	Clinical exams	Clinical exams are exams administered by investigator during a consultation. There are four exams : inspection : presence or not of a hematoma and oedema; palpation : pain or not with palpation; mobilization : 3 items with 2 answers (Yes/No); support capacity : 2 items with 2 answers (Yes/No)	day 0
Secondary	Clinical exams	Clinical exams are exams administered by investigator during a consultation. There are four exams : inspection : presence or not of a hematoma and oedema; palpation : pain or not with palpation; mobilization : 3 items with 2 answers (Yes/No); support capacity : 2 items with 2 answers (Yes/No)	day 21
Secondary	Parents questionnaire	It is a questionnaire for parents that assesses the feeling about the children care, with 3 questions.	day 21
Secondary	Intercurrent consultation	Adjudicated intercurrent consultation (Other medical consultation than those planned) during the study treatment period	between day 0 and day 42
Secondary	injury during removal of the device	Adjudicated injury during removal of the device during the study treatment period	between day 0 and day 42
Secondary	Negative predictive value (VPN) of "combined clinical criteria"	Negative predictive value (VPN) of "combined clinical criteria" in the detection of low-grade bone or ligament damage to the ankle in children compared to ultrasound/radiography.	day 0
Secondary	Sensitivity and specificity of local skin signs	Sensitivity and specificity of local skin signs (INSPECTION line of the clinical examination questionnaire) to detect high-grade ligament damage on ultrasound.	day 0
Secondary	Comparison between clinical exams and the radiography results.	Clinical exams are exams administred by investigator during a consultation (inspection, palpation, mobilization, support capacity).The results of this exams are compared to radiography results at the inclusion (origin and localization of injury)	day 0
Secondary	Comparison between the clinical exams and the ultrasound results.	Clinical exams are exams administred by investigator during a consultation (inspection, palpation, mobilization, support capacity).The results of this exams are compared to ultrasound results at the inclusion (origin and localization of injury) .	day 0
Secondary	Comparison between the radiography results and the ultrasound results.	Ultrasound results are compared to radiography results at the inclusion (origin and localization of injury) .	day 0