Arthroplasty Cements Outcomes - A Post-market Follow-up
Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
Teknimed
1,050 participants
Dec 16, 2020
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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
- 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 Criteria4
- 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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Interventions
Joint replacement with cemented prosthetic components
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06354543