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

NCT04599829 | Terminated

• 1 other identifier: ankleSTRONG100-500-900
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Confidence level

  At baseline and 12 weeks of follow-up

• Ankle instability

  At 4 weeks, 8 weeks and 12 weeks of follow-up

• Ankle pain

  At 4 weeks, 8 weeks and 12 weeks of follow-up

• Safety (adverse events)

  12 weeks of follow-up

Study Arms (6)

Orthosis Group 1

Use of AnkleSTRONG100 device

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

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

Device: AnkleSTRONG100/500/900

Control Group 3

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

Interventions

AnkleSTRONG100/500/900 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.

Orthosis Group 1; Orthosis Group 2; Orthosis Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Decathlon SE: lead
• EFOR, France: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

Location

Study Officials

• Valérie WIECZOREK

  Centre Hospitalier Universitaire de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: October 23, 2020
• Study Start: June 3, 2021
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: January 17, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)