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

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 Overview

• Status: Terminated
• Conditions: Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree; Ankle Sprain 3Rd Degree
• Intervention / Treatment: Device: AnkleSTRONG100/500/900

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Centre Hospitalier Universitaire de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject with ankle sprain whose current condition of his/her ankle allows the subject to resume usual physical activity

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Orthosis Group 1; Use of AnkleSTRONG100 device	Device: 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.
Control Group 1; Control Group of the AnkleSTRONG100 Orthosis Group - No use of the device
Orthosis Group 2; Use of AnkleSTRONG500 device	Device: 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.
Control Group 2; Control Group of the AnkleSTRONG500 Orthosis Group - No use of the device
Orthosis Group 3; Use of AnkleSTRONG900 device	Device: 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.
Control Group 3; Control Group of the AnkleSTRONG900 Orthosis Group - No use of the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (adverse events)	Comparison of adverse events rates between the groups (orthosis vs control), for each device model	12 weeks of follow-up
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	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	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	At 4 weeks, 8 weeks and 12 weeks of follow-up

Collaborators and Investigators

• Sponsor: Decathlon SE
• Collaborators: EFOR, France
• Investigators: Principal Investigator: Valérie WIECZOREK, Centre Hospitalier Universitaire de Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: ankleSTRONG100-500-900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No