Trials / Terminated
TerminatedNCT04599829
Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- Decathlon SE · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-06-03
- Primary completion
- 2022-11-29
- Completion
- 2022-11-29
- First posted
- 2020-10-23
- Last updated
- 2023-01-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04599829. Inclusion in this directory is not an endorsement.