Post-market follow-up on Teknimed arthroplasty cements
Official title: Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
Run by Teknimed · NCT06354543 · Data updated 2026-11-12
This study is trying to see how safe and effective Teknimed's bone cements and cement restrictor are for patients who have had joint replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1050 (estimated) |
| Sponsor | Teknimed Industry-sponsored |
| Locations | 10 sites (Brive-la-Gaillarde, Aquitaine and 9 other locations) |
| Status | Recruiting |
| Started | December 16, 2020 |
| Main results expected | December 2035 |
| Study ends | December 2045 |
| Registry record updated | March 25, 2025 |
| Trial ID | NCT06354543 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are undergoing primary or revision arthroplasty procedures with Teknimed bone cements.
✕Probably not a fit
Patients who are pregnant or under guardianship will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study collects clinical data on the safety and performance of Teknimed's range of arthroplasty products, including CEMFIX® and GENTAFIX® bone cements and CEMSTOP® cement restrictor. It is a multicentric, ambispective observational study that includes both retrospective and prospective patient data. Participants will be followed according to local standard medical care, allowing for real-life assessment of these products' effectiveness and safety. The aim is to confirm previous findings from post-market surveillance and earlier studies.
Why it matters
Potential benefit: If successful, this study could provide valuable long-term safety and efficacy data for patients undergoing joint replacement surgeries using Teknimed products.
How similar studies have gone: Other studies have shown success in assessing the performance of arthroplasty products, but this specific follow-up is focused on Teknimed's established products.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be 18 years or older. * Be willing to sign an informed consent approved by Institutional Review Board (IRB) or European Commission (EC) (when applicable) or not oppose to the use of their clinical data in the study * For prospective inclusion: be considered for an arthroplasty procedure with one of the TEKNIMED orthopaedic cement and/or cement restrictor comprised in this study (primary or revision surgery). * For retrospective inclusion: have undergone a primary or revision arthroplasty procedure with a TEKNIMED orthopaedic cement and/or cement restrictor between the 1st January 2016 and the date of the site initiation visit (SIV). * Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (where applicable). Exclusion Criteria: * Patient under trusteeship or guardianship, * Women who are pregnant * Patient unable to follow the protocol * Patient whose vital prognosis is unfavorable (according to investigator's opinion)
Where it's running
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CH de Brive
Brive-la-Gaillarde, Aquitaine, France Recruiting -
Clinique du Vivarais
Aubenas, Auvergne-Rhône-Alpes, France Recruiting -
Clinique du Val d'Ouest
Écully, Auvergne-Rhône-Alpes, France Recruiting -
Cabinet de consultation
Évreux, Eure, France Recruiting -
Clinique de l'Atlantique
Puilboreau, New Aquitaine, France Recruiting -
Clinique du Dr Henri Guillard
Coutances, Normandy, France Recruiting
Show 4 more locations
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Mirouse
Boujan-sur-Libron, Occitanie, France Recruiting -
Hôpital Européen Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, France Recruiting -
Instituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, Italy Recruiting -
Ospedale Santissima Annunziata
Cento, Emilia-Romagna, Italy Recruiting
Study contacts
- Study coordinator: Solange VAN DE MOORTELE, PhD
- Email: s.vandemoortele@teknimed.com
- Phone: +33 5 34 25 26 79
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.