NCT06354543 Arthroplasty Cements Outcomes - A Post-market Follow-up
| NCT ID | NCT06354543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Teknimed |
| Condition | Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,050 participants |
| Start Date | 2020-12-16 |
| Primary Completion | 2035-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,050 participants in total. It began in 2020-12-16 with a primary completion date of 2035-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06354543 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06354543 currently recruiting?
Yes, NCT06354543 is actively recruiting participants. Contact the research team at s.vandemoortele@teknimed.com for enrollment information.
Where is the NCT06354543 trial being conducted?
This trial is being conducted at Brive-la-Gaillarde, France, Aubenas, France, Écully, France, Évreux, France and 6 additional locations.
Who is sponsoring the NCT06354543 clinical trial?
NCT06354543 is sponsored by Teknimed. The trial plans to enroll 1,050 participants.