Post-market follow-up on Teknimed arthroplasty cements
Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
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 |
|---|---|
| Enrollment | 1050 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Teknimed Industry-sponsored |
| Locations | 10 sites (Brive-la-Gaillarde, Aquitaine and 9 other locations) |
| Trial ID | NCT06354543 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing primary or revision arthroplasty procedures with Teknimed bone cements.
Not a fit: Patients who are pregnant or under guardianship will not benefit from this study.
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 performed: Other studies have shown success in assessing the performance of arthroplasty products, but this specific follow-up is focused on Teknimed's established products.
Eligibility criteria
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 this trial is running
Brive-la-Gaillarde, Aquitaine and 9 other locations
- 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)
- 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
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.