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

Ankle Sprain 2Nd Degree Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04599829
• Other study ID #: ankleSTRONG100-500-900
• Status: Terminated
• Start date: June 3, 2021
• Est. completion date: November 29, 2022

Study information

• Verified date: September 2022
• Source: Decathlon SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain 1St Degree
• Ankle Sprain 2Nd Degree
• Ankle Sprain 3Rd Degree
• Sprains and Strains

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Decathlon SE	EFOR, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Safety (adverse events)	Comparison of adverse events rates between the groups (orthosis vs control), for each device model	12 weeks of follow-up