Informations générales (source: ClinicalTrials.gov)
Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
Observational
Teknimed (Voir sur ClinicalTrials)
décembre 2020
décembre 2045
26 mars 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Cabinet de consultation - 27000 - Evreux - Eure - France | Edouard DECRETTE, MD | Contact (sur clinicalTrials) | |||
| CH de Brive - 19100 - Brive-la-Gaillarde - Aquitaine - France | VAYSSE-VIC Mathieu, MD | Contact (sur clinicalTrials) | |||
| Clinique de l'Atlantique - 17138 - Puilboreau - Nouvelle-aquitaine - France | Cédric BOUQUET, MD | Contact (sur clinicalTrials) | |||
| Clinique du Dr Henri Guillard - 50200 - Coutances - Normandie - France | Olivier COSSART, MD | Contact (sur clinicalTrials) | |||
| Clinique du Val d'Ouest - 69130 - Ecully - Auvergne-rhône-alpes - France | Benoît GIRAUD, MD | Contact (sur clinicalTrials) | |||
| Clinique du Vivarais - 07200 - Aubenas - Auvergne-rhône-alpes - France | Michel MILAIRE, MD | Contact (sur clinicalTrials) | |||
| Hôpital Européen Marseille - 13003 - Marseille - Provence-alpes-cote D'azur - France | Maxime MUNIER, MD | Contact (sur clinicalTrials) | |||
| MIROUSE - 34760 - Boujan-sur-Libron - Occitanie - France | Guillaume MIROUSE, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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).
- 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).
- 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)