NCT06532929 Sport Surgery Products Outcomes - A Post-market Follow-up
| NCT ID | NCT06532929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Teknimed |
| Condition | Sport Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 390 participants |
| Start Date | 2019-11-01 |
| Primary Completion | 2036-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 390 participants in total. It began in 2019-11-01 with a primary completion date of 2036-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 devices currently used in orthopaedic surgery. With the increasing use of these procedures, there is a need for real-life long-term safety and efficacy data on these products. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06532929 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sport Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06532929 currently recruiting?
Yes, NCT06532929 is actively recruiting participants. Contact the research team at s.vandemoortele@teknimed.com for enrollment information.
Where is the NCT06532929 trial being conducted?
This trial is being conducted at Aubenas, France, Guilherand-Granges, France, Guilherand-Granges, France, Brive-la-Gaillarde, France and 6 additional locations.
Who is sponsoring the NCT06532929 clinical trial?
NCT06532929 is sponsored by Teknimed. The trial plans to enroll 390 participants.