Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-03

Study Completion Date

2022-11-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Ankle Sprain 1St Degree Ankle Sprain 2Nd Degree Ankle Sprain 3Rd Degree

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Orthosis Group 1

Use of AnkleSTRONG100 device

AnkleSTRONG100/500/900

Intervention Type DEVICE

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.

Control Group 1

Control Group of the AnkleSTRONG100 Orthosis Group - No use of the device

No interventions assigned to this group

Orthosis Group 2

Use of AnkleSTRONG500 device

AnkleSTRONG100/500/900

Intervention Type DEVICE

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.

Control Group 2

Control Group of the AnkleSTRONG500 Orthosis Group - No use of the device

No interventions assigned to this group

Orthosis Group 3

Use of AnkleSTRONG900 device

AnkleSTRONG100/500/900

Intervention Type DEVICE

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.

Control Group 3

Control Group of the AnkleSTRONG900 Orthosis Group - No use of the device

No interventions assigned to this group

Interventions

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AnkleSTRONG100/500/900

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No