Ankle InjuriesCHEVIPEDNCT05009342
Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children
A study testing below-knee soft resin cast and Below-knee rigid resin cast in people with Ankle Injuries and Ligament Injury, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Ankle Injuries, Ligament Injury
- What is being tested?
- below-knee soft resin cast and Below-knee rigid resin cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2021to 9 Jun 2023
- Phase
- Interventional
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 :
- Clinical evaluation of treatment at 3 weeks in immediate post-immobilization.
- Evaluation of the management satisfaction (effectiveness and understanding) and the treatment tolerance .
- Evaluation of the time taken to resume painless support after immobilization.
- Point of interest evaluation
- Determine the diagnostic performance of the "combined clinical criteria" in comparison with the ultrasound/radiography couple.
- Evaluation of the diagnostic performance of clinical inspection criteria (edema, bruise) in high-grade ligament damage.
- Evaluation of the link between the "combined clinical criteria" and the results of the radiography.
- Evaluation of the relationship between "combined clinical criteria" and ultrasound results.
- 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
- Ankle Injuries, Ligament Injury
- Being tested
- below-knee soft resin cast, Below-knee rigid resin cast
- Keywords
- low-grade, osteo-ligament injuries, children, soft resin ankle brace, Below-knee rigid resin cast
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
below-knee soft resin castDevice
Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)
Below-knee rigid resin castDevice
Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Below-knee rigid resin cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 2 months
Secondary outcomes (14)
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.
Measured: day 0
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.
Measured: day 21
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)
Measured: day 0
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)
Measured: day 21
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)
Measured: day 0
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)
Measured: day 21
Parents questionnaire
It is a questionnaire for parents that assesses the feeling about the children care, with 3 questions.
Measured: day 21
Intercurrent consultation
Adjudicated intercurrent consultation (Other medical consultation than those planned) during the study treatment period
Measured: between day 0 and day 42
injury during removal of the device
Adjudicated injury during removal of the device during the study treatment period
Measured: between day 0 and day 42
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.
Measured: day 0
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.
Measured: day 0
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)
Measured: day 0
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) .
Measured: day 0
Comparison between the radiography results and the ultrasound results.
Ultrasound results are compared to radiography results at the inclusion (origin and localization of injury) .
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start9 Sep 2021
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Why it stopped: Inclusion of patients very limited due to lack of time and human resources dedicated to research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, randomized, non-inferiority, without blinding, controlled trial with 2 parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009342
- Sponsor's protocol ID
- 29BRC21.0016
- Acronym
- CHEVIPED
- Status last verified
- Jul 2023
- First submitted
- 6 Aug 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children
- ClinicalTrials.gov ID
- NCT05009342
- Acronym / sponsor ID
- CHEVIPED / 29BRC21.0016
- Conditions
- Ankle Injuries, Ligament Injury
- Keywords
- low-grade, osteo-ligament injuries, children, soft resin ankle brace, Below-knee rigid resin cast
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion of patients very limited due to lack of time and human resources dedicated to research.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 17 Aug 2021 (actual)
- 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.
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 :
- Clinical evaluation of treatment at 3 weeks in immediate post-immobilization.
- Evaluation of the management satisfaction (effectiveness and understanding) and the treatment tolerance .
- Evaluation of the time taken to resume painless support after immobilization.
- Point of interest evaluation
- Determine the diagnostic performance of the "combined clinical criteria" in comparison with the ultrasound/radiography couple.
- Evaluation of the diagnostic performance of clinical inspection criteria (edema, bruise) in high-grade ligament damage.
- Evaluation of the link between the "combined clinical criteria" and the results of the radiography.
- Evaluation of the relationship between "combined clinical criteria" and ultrasound results.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, randomized, non-inferiority, without blinding, controlled trial with 2 parallel groups
| Arm | Type | Receives |
|---|---|---|
| Below-knee soft resin cast | Experimental | Device: below-knee soft resin castBelow-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. |
| Below-knee rigid resin cast | Other | Device: Below-knee rigid resin castBelow-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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| below-knee soft resin castPatients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1) | Device | Below-knee soft resin cast |
| Below-knee rigid resin castPatients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1) | Device | Below-knee rigid resin cast |
Primary outcome
Activities Scale for Kids (ASKp)
Time frame: At 2 months
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).
14 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: day 0
Visual Analogue Scale (VAS)
Time frame: day 21
Numeric Scale (NS)
Time frame: day 0
Numeric Scale (NS)
Time frame: day 21
Clinical exams
Time frame: day 0
Clinical exams
Time frame: day 21
Parents questionnaire
Time frame: day 21
Intercurrent consultation
Time frame: between day 0 and day 42
injury during removal of the device
Time frame: between day 0 and day 42
Negative predictive value (VPN) of "combined clinical criteria"
Time frame: day 0
Sensitivity and specificity of local skin signs
Time frame: day 0
Comparison between clinical exams and the radiography results.
Time frame: day 0
Comparison between the clinical exams and the ultrasound results.
Time frame: day 0
Comparison between the radiography results and the ultrasound results.
Time frame: day 0
Results and safety
The study was stopped early (reason given: Inclusion of patients very limited due to lack of time and human resources dedicated to research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing below-knee soft resin cast and Below-knee rigid resin cast in people with Ankle Injuries and Ligament Injury, 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 13 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: stopped early, as of the sponsor's last update on 4 Mar 2024. 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 was stopped early (reason given: Inclusion of patients very limited due to lack of time and human resources dedicated to research.). Results are not available in the source record.
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?
Activities Scale for Kids (ASKp) (time frame: At 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2024.