NCT05552235

Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Decathlon SE · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device 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 ElbowSoft300 device and support peer-reviewed publications on products performance and safety.

Conditions

• Epicondylitis
• Tendonitis Elbow
• Elbow Injury

Interventions

Type	Name	Description
DEVICE	Elbow SOFT 300	15 patients will be included in this group and will used the medical device ElbowSOFT 300 during sport practice (at least 2 sport sessions per week), for 6 weeks.
OTHER	Control group	15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device), for at least 2 sport sessions per week during 6 weeks.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-09-23
• Last updated: 2023-01-17

Locations

2 sites across 1 country: France