Ankle Sprain 1St DegreeNCT04599829
Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain
An observational study of Ankle Sprain 1St Degree and Ankle Sprain 2Nd Degree, run by Decathlon SE at 1 site in France.
Trial summary
Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence. The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree
- What is being tested?
- AnkleSTRONG100/500/900
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2021to 29 Nov 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with ankle sprain whose current condition of his/her ankle allows the subject to resume usual physical activity
Who may be able to join
- Subject is aged ≥ 18 years old
- Subject has a recent mild OR moderate OR serious ankle sprain
- The current condition of his/her ankle allows the subject to resume usual physical activity
- Subject has been informed and is willing to sign an informed consent form
- Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks)
- Subject is affiliated to the French social security regime
Show all 13Show fewer
- Non-inclusion Criteria:
- Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
- Subject has worn a support (ankle brace or articulated orthosis) since his/her recent injury
- Subject has resumed regular physical activity since his/her recent injury
- Subject has any medical condition that could impact the study at investigator's discretion
- Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, polyester, cotton)
- Adult subject to legal protection measure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence.
The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). The differences between the devices is based on the strength of compression and the ankle maintain.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Ankle STRONG products to demonstrate safety and performance of these devices in a real-world setting.
- Being tested
- AnkleSTRONG100/500/900
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnkleSTRONG100/500/900Device
At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (3 device types: Ankle STRONG 100/500/900) totalling 90 patients will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use an ankle support device.
| Study group | Role | What they receive |
|---|---|---|
| Orthosis Group 1 | Use of AnkleSTRONG100 device Receives: Device: AnkleSTRONG100/500/900 | |
| Control Group 1 | Control Group of the AnkleSTRONG100 Orthosis Group - No use of the device | |
| Orthosis Group 2 | Use of AnkleSTRONG500 device Receives: Device: AnkleSTRONG100/500/900 | |
| Control Group 2 | Control Group of the AnkleSTRONG500 Orthosis Group - No use of the device | |
| Orthosis Group 3 | Use of AnkleSTRONG900 device Receives: Device: AnkleSTRONG100/500/900 | |
| Control Group 3 | Control Group of the AnkleSTRONG900 Orthosis Group - No use of the device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional score
Comparison of the functional result (Karlsson Ankle Function Score, 0-100 points) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
Measured: 12 weeks of follow-up
Secondary outcomes (4)
Confidence level
Gap in the confidence level (patient rated outcome with 6 questions, ranging from 0 to 100) related to physical activity, between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
Measured: At baseline and 12 weeks of follow-up
Ankle instability
Comparison of ankle instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control), for each device model
Measured: At 4 weeks, 8 weeks and 12 weeks of follow-up
Ankle pain
Comparison of ankle pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control), for each device model
Measured: At 4 weeks, 8 weeks and 12 weeks of follow-up
Safety (adverse events)
Comparison of adverse events rates between the groups (orthosis vs control), for each device model
Measured: 12 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start3 Jun 2021
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Why it stopped: Sponsor decision : Difficulties of inclusion and revision of the clinical evaluation report of the medical device under evaluation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Sprain 1St DegreeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Decathlon SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Responsible party
- Sponsor
- Investigators
- Valérie WIECZOREK, Principal investigator, Centre Hospitalier Universitaire de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599829
- Sponsor's protocol ID
- ankleSTRONG100-500-900
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain
- ClinicalTrials.gov ID
- NCT04599829
- Acronym / sponsor ID
- ankleSTRONG100-500-900
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision : Difficulties of inclusion and revision of the clinical evaluation report of the medical device under evaluation.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Decathlon SEIndustry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 23 Oct 2020 (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.
Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence.
The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). The differences between the devices is based on the strength of compression and the ankle maintain.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Ankle STRONG products to demonstrate safety and performance of these devices in a real-world setting.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Orthosis Group 1 | – | Device: AnkleSTRONG100/500/900Use of AnkleSTRONG100 device |
| Control Group 1 | – | –Control Group of the AnkleSTRONG100 Orthosis Group - No use of the device |
| Orthosis Group 2 | – | Device: AnkleSTRONG100/500/900Use of AnkleSTRONG500 device |
| Control Group 2 | – | –Control Group of the AnkleSTRONG500 Orthosis Group - No use of the device |
| Orthosis Group 3 | – | Device: AnkleSTRONG100/500/900Use of AnkleSTRONG900 device |
| Control Group 3 | – | –Control Group of the AnkleSTRONG900 Orthosis Group - No use of the device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with ankle sprain whose current condition of his/her ankle allows the subject to resume usual physical activity
Key inclusion criteria (13 listed)
- Subject is aged ≥ 18 years old
- Subject has a recent mild OR moderate OR serious ankle sprain
- The current condition of his/her ankle allows the subject to resume usual physical activity
- Subject has been informed and is willing to sign an informed consent form
- Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AnkleSTRONG100/500/900At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (3 device types: Ankle STRONG 100/500/900) totalling 90 patients will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use an ankle support device. | Device | Orthosis Group 1, Orthosis Group 2, Orthosis Group 3 |
Primary outcome
Functional score
Time frame: 12 weeks of follow-up
Comparison of the functional result (Karlsson Ankle Function Score, 0-100 points) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
4 secondary outcomes
Confidence level
Time frame: At baseline and 12 weeks of follow-up
Ankle instability
Time frame: At 4 weeks, 8 weeks and 12 weeks of follow-up
Ankle pain
Time frame: At 4 weeks, 8 weeks and 12 weeks of follow-up
Safety (adverse events)
Time frame: 12 weeks of follow-up
Results and safety
The study was stopped early (reason given: Sponsor decision : Difficulties of inclusion and revision of the clinical evaluation report of the medical device under evaluation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
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.
Valérie WIECZOREK principal investigator
Centre Hospitalier Universitaire de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprain 1St Degree and Ankle Sprain 2Nd Degree, run by Decathlon SE 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 13 inclusion and 0 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 17 Jan 2023. 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: Sponsor decision : Difficulties of inclusion and revision of the clinical evaluation report of the medical device under evaluation.). 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?
Functional score (time frame: 12 weeks of follow-up). 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 17 Jan 2023.