Post-market follow-up of Teknimed sports surgery products
Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up
This study looks at how well Teknimed's sports surgery products work and their safety for patients who have had orthopedic surgeries using these devices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Teknimed Industry-sponsored |
| Locations | 10 sites (Aubenas, Ardèche and 9 other locations) |
| Trial ID | NCT06532929 on ClinicalTrials.gov |
What this trial studies
This study is an observational follow-up to assess the performance, safety, and usability of Teknimed's range of sports surgery products used in orthopedic procedures. It includes both retrospective and prospective data collection from patients who have undergone surgeries involving these products. The study aims to gather long-term safety and efficacy data to ensure that these devices meet clinical standards in real-life settings. Patients will be monitored according to local medical care protocols.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing orthopedic surgery with Teknimed products.
Not a fit: Patients who are pregnant or under legal guardianship will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of Teknimed's sports surgery products, potentially improving patient outcomes.
How similar studies have performed: While this study builds on existing knowledge of orthopedic devices, it focuses specifically on Teknimed products, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aubenas, Ardèche and 9 other locations
- Milaire — Aubenas, Ardèche, France (Not_yet_recruiting)
- Centre Claude Bernard — Guilherand-Granges, Ardèche, France (Recruiting)
- Centre Mistral -Clinique Pasteur — Guilherand-Granges, Ardèche, France (Recruiting)
- Orthopole des 3 provinces — Brive-la-Gaillarde, Corrèze, France (Recruiting)
- Clinique Pasteur — Bergerac, Dordogne, France (Recruiting)
- Médipôle Toulouse — Toulouse, Haute-Garonne, France (Recruiting)
- Clinique Chénieux — Limoges, Haute-Vienne, France (Completed)
- Clinique St Privat — Boujan-sur-Libron, Hérault, France (Recruiting)
- Clinique Via Domitia — Lunel, Hérault, France (Active_not_recruiting)
- Clinique Esquirol Saint-Hilaire — Agen, Lot-et-Garonne, France (Recruiting)
Study contacts
- Study coordinator: Solange VAN DE MOORTELE, PhD
- Email: s.vandemoortele@teknimed.com
- Phone: +33 5 34 25 26 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.