NCT05552209

Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Decathlon SE · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

Summary

Decathlon has developed elbowMID500 and elbowSTRAP products which are medical devices that must be positioned around the elbow during sport practice, in order to limit symptoms related to epicondylitis or previous sprains (elbowMID500 only). The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon elbowMID500 and elbowSTRAP products to demonstrate safety and performance of these devices in a real-world setting. Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon elbowMID500 and elbowSTRAP devices and support peer-reviewed publications on products performance and safety.

Conditions

• Epicondylitis
• Elbow Sprain

Interventions

Type	Name	Description
DEVICE	Elbow MID 500	15 patients will be included in this group and will used the medical device Elbow MID 500 during sport practice (at least 2 sport sessions per week), for 6 weeks.
OTHER	Control group Elbow MID 500	15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow MID 500), for at least 2 sport sessions per week during 6 weeks.
DEVICE	Elbow STRAP	15 patients will be included in this group and will used the medical device Elbow STRAP during sport practice (at least 2 sport sessions per week), for 6 weeks.
OTHER	Control group Elbow STRAP	15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow STRAP), for at least 2 sport sessions per week during 6 weeks.

Timeline

• Start date: 2022-09-21
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2022-09-23
• Last updated: 2023-01-17

Locations

4 sites across 1 country: France