Status:
RECRUITING
Sport Surgery Products Outcomes - A Post-market Follow-up
Lead Sponsor:
Teknimed
Conditions:
Sport Surgery
Eligibility:
All Genders
18+ years
Brief Summary
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products. TEKNIMED has developed several dev...
Detailed Description
It is admitted that: * Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction, * Bioabsorbable pins are indicated for the realignment and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2036
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT06532929
Start Date
November 1 2019
End Date
November 1 2036
Last Update
March 27 2025
Active Locations (10)
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1
Milaire
Aubenas, Ardèche, France, 07200
2
Centre Claude Bernard
Guilherand-Granges, Ardèche, France, 07500
3
Centre Mistral -Clinique Pasteur
Guilherand-Granges, Ardèche, France, 07500
4
Orthopole des 3 provinces
Brive-la-Gaillarde, Corrèze, France, 19100