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Arthroplasty Cements Outcomes - A Post-market Follow-up

Recruitingn/aAges 18 Years - anyAllTeknimed
NCT06354543 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels. Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Cemented joint arthroplasty
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Where

10 sites
CH de Brive
Brive-la-Gaillarde, France
Clinique du Vivarais
Aubenas, France
Clinique du Val d'Ouest
Écully, France
Cabinet de consultation
Évreux, France
Clinique de l'Atlantique
Puilboreau, France
Clinique du Dr Henri Guillard
Coutances, France
MIROUSE
Boujan-sur-Libron, France
Hôpital Européen Marseille
Marseille, 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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