Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain
- Conditions
- Ankle Sprain 3Rd DegreeAnkle Sprain 2Nd DegreeAnkle Sprain 1St Degree
- Interventions
- Device: AnkleSTRONG100/500/900
- Registration Number
- NCT04599829
- Lead Sponsor
- Decathlon SE
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Orthosis Group 2 AnkleSTRONG100/500/900 Use of AnkleSTRONG500 device Orthosis Group 1 AnkleSTRONG100/500/900 Use of AnkleSTRONG100 device Orthosis Group 3 AnkleSTRONG100/500/900 Use of AnkleSTRONG900 device
- Primary Outcome Measures
Name Time Method Functional score 12 weeks of follow-up 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
- Secondary Outcome Measures
Name Time Method Confidence level At baseline and 12 weeks of follow-up 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
Ankle instability At 4 weeks, 8 weeks and 12 weeks of follow-up 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
Ankle pain At 4 weeks, 8 weeks and 12 weeks of follow-up Comparison of ankle pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control), for each device model
Safety (adverse events) 12 weeks of follow-up Comparison of adverse events rates between the groups (orthosis vs control), for each device model
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Lille
🇫🇷Lille, France