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

Decathlon

Status: Terminated

Conditions: Ankle Sprain 2Nd Degree; Ankle Sprain 3Rd Degree; Ankle Sprain 1St Degree

Treatments: Device: AnkleSTRONG100/500/900

Study type: Observational

Funder types: Industry

Identifiers

NCT04599829

ankleSTRONG100-500-900

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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

Trial design

15 participants in 6 patient groups

Orthosis Group 1

Description:

Use of AnkleSTRONG100 device

Treatment:

Device: AnkleSTRONG100/500/900

Control Group 1

Description:

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

Orthosis Group 2

Description:

Use of AnkleSTRONG500 device

Treatment:

Device: AnkleSTRONG100/500/900

Control Group 2

Description:

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

Orthosis Group 3

Description:

Use of AnkleSTRONG900 device

Treatment:

Device: AnkleSTRONG100/500/900

Control Group 3

Description:

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