Clinical Research Directory
Browse clinical research sites, groups, and studies.
Arthroplasty Cements Outcomes - A Post-market Follow-up
Sponsor: Teknimed
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.
Official title: Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1050
Start Date
2020-12-16
Completion Date
2045-12
Last Updated
2025-03-25
Healthy Volunteers
No
Conditions
Interventions
Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
Locations (10)
CH de Brive
Brive-la-Gaillarde, Aquitaine, France
Clinique du Vivarais
Aubenas, Auvergne-Rhône-Alpes, France
Clinique du Val d'Ouest
Écully, Auvergne-Rhône-Alpes, France
Cabinet de consultation
Évreux, Eure, France
Clinique du Dr Henri Guillard
Coutances, Normandy, France
Clinique de l'Atlantique
Puilboreau, Nouvelle-Aquitaine, France
MIROUSE
Boujan-sur-Libron, Occitanie, France
Hôpital Européen Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, France
Instituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, Italy
Ospedale Santissima Annunziata
Cento, Emilia-Romagna, Italy