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

Recruitingn/aAges 18 Years - anyAllTeknimed
NCT06532929 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Orthopaedic surgeries (ankle)
  • Orthopaedic surgeries (shoulder)
  • Orthopaedic surgeries (knee)
  • Orthopaedic surgeries
  • Orthopaedic surgeries (foot)
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Where

10 sites
Milaire
Aubenas, France
Centre Claude Bernard
Guilherand-Granges, France
Centre Mistral -Clinique Pasteur
Guilherand-Granges, France
Orthopole des 3 provinces
Brive-la-Gaillarde, France
Clinique Pasteur
Bergerac, France
Médipôle Toulouse
Toulouse, France
Clinique Chénieux
Limoges, France
Clinique St Privat
Boujan-sur-Libron, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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