Sport Surgery Products Outcomes - A Post-market Follow-up

Launched by TEKNIMED · Jul 30, 2024

Keywords

ClinConnect Summary

The Sport Surgery Products Outcomes trial is a study being conducted by Teknimed to learn more about the safety and effectiveness of their sports surgery devices. These devices are used in orthopedic surgeries, and as more people undergo these procedures, it’s important to gather long-term data on how well they perform in real-life situations. The study will include both new and previously treated patients, and it aims to follow them over time to see how they are doing after using these products.

To participate in the study, you need to be at least 18 years old and willing to agree to the use of your medical data. If you are having surgery that involves a Teknimed sports surgery product, you may qualify to join the study. If you've already had surgery with one of these products since January 2016, you could also be included. Participants can expect regular follow-ups as part of their usual medical care to monitor their progress. It’s also important to know that certain individuals, such as pregnant women or those under guardianship, cannot participate. This study is a great opportunity to contribute to the understanding of these surgical products and help improve patient care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be 18 years or older.
• • Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France)
• For prospective inclusion:
• • - Be considered for a surgery with one of the TEKNIMED sports surgery product comprised in this study.
• For retrospective inclusion:
• • Have undergone a surgery with a TEKNIMED sports surgery product between the 1st January 2016 and the date of the site initiation visit.
• • Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).
• Exclusion Criteria:
• • Patients presenting one of the following conditions will not be included: under trusteeship or guardianship, pregnancy
• • Anyone of the contraindications mentioned in the respective IFU of each device under study