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Arthroplasty Cements Outcomes - A Post-market Follow-up

NCT06354543 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1050

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • Arthroplasty

Interventions

DEVICE

Cemented joint arthroplasty

Joint replacement with cemented prosthetic components

Sponsors & Collaborators

  • Teknimed

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2035-12-31
Completion
2045-12-31

Countries

  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06354543 on ClinicalTrials.gov