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Clinical Trials in Italy / NCT06354543
Recruiting Observational

Arthroplasty Cements Outcomes - A Post-market Follow-up

NCT06354543 · tracked via the Priya Life Science Italy tracker
Sponsor
Teknimed
Phase
Observational
Started
2020-12-16
Last updated
2025-03-25

Condition(s) studied

Arthroplasty

Investigational drug(s) / intervention(s)

Cemented joint arthroplasty

Cemented joint arthroplasty: Joint replacement with cemented prosthetic components

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Survival rate — 15 years (until the lifetime of the device)
    Prosthesis survival defined as time from implantation to revision surgery due to a cement defect.
  • Superficial and/or deep postoperative infection rate. — 15 years (until the lifetime of the device)
    In the case of cements with gentamicin, superficial and/or deep postoperative infection rate.

Trial sites (10)

FacilityCityRegionStatus
CH de Brive Brive-la-Gaillarde Aquitaine Recruiting
Clinique du Vivarais Aubenas Auvergne-Rhône-Alpes Recruiting
Clinique du Val d'Ouest Écully Auvergne-Rhône-Alpes Recruiting
Cabinet de consultation Évreux Eure Recruiting
Clinique de l'Atlantique Puilboreau New Aquitaine Recruiting
Clinique du Dr Henri Guillard Coutances Normandy Recruiting
MIROUSE Boujan-sur-Libron Occitanie Recruiting
Hôpital Européen Marseille Marseille Provence-Alpes-Côte d'Azur Region Recruiting
Instituto Ortopedico Rizzoli Bologna Emilia-Romagna Recruiting
Ospedale Santissima Annunziata Cento Emilia-Romagna Recruiting

Other trials for the same condition

PRIMA EU Retrospective & Prospective Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06354543 on ClinicalTrials.gov ↗ ← All trials in Italy