Actively Recruiting
Arthroplasty Cements Outcomes - A Post-market Follow-up
Led by Teknimed · Updated on 2025-03-25
1050
Participants Needed
10
Research Sites
1302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Arthroplasty Cements Outcomes - A Post-market Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older.
- Be willing to sign an informed consent approved by Institutional Review Board (IRB) or European Commission (EC) or not oppose the use of clinical data in the study.
- For prospective inclusion: be scheduled for an arthroplasty procedure using Teknimed orthopaedic cement and/or cement restrictor (primary or revision surgery).
- For retrospective inclusion: have undergone primary or revision arthroplasty with Teknimed orthopaedic cement and/or cement restrictor between January 1, 2016 and the site initiation visit.
- Be informed of the study and not oppose the use of clinical data or be willing to sign informed consent during the first follow-up visit if applicable.
You will not qualify if you...
- Patient under trusteeship or guardianship.
- Women who are pregnant.
- Patient unable to follow the protocol.
- Patient with an unfavorable vital prognosis according to investigator's opinion.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
CH de Brive
Brive-la-Gaillarde, Aquitaine, France, 19100
Actively Recruiting
2
Clinique du Vivarais
Aubenas, Auvergne-Rhône-Alpes, France, 07200
Actively Recruiting
3
Clinique du Val d'Ouest
Écully, Auvergne-Rhône-Alpes, France, 69130
Actively Recruiting
4
Cabinet de consultation
Évreux, Eure, France, 27000
Actively Recruiting
5
Clinique de l'Atlantique
Puilboreau, New Aquitaine, France, 17138
Actively Recruiting
6
Clinique du Dr Henri Guillard
Coutances, Normandy, France, 50200
Actively Recruiting
7
MIROUSE
Boujan-sur-Libron, Occitanie, France, 34760
Actively Recruiting
8
Hôpital Européen Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13003
Actively Recruiting
9
Instituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, Italy, 40136
Actively Recruiting
10
Ospedale Santissima Annunziata
Cento, Emilia-Romagna, Italy, 44042
Actively Recruiting
Research Team
S
Solange VAN DE MOORTELE, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
21
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