Status:
RECRUITING
Arthroplasty Cements Outcomes - A Post-market Follow-up
Lead Sponsor:
Teknimed
Conditions:
Arthroplasty
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
It is admitted that: * Joint replacement is a commonly performed major surgical procedure that has considerable success in alleviating pain and disability; * These procedures may be done with the hel...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2045
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT06354543
Start Date
December 16 2020
End Date
December 1 2045
Last Update
March 25 2025
Active Locations (10)
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1
CH de Brive
Brive-la-Gaillarde, Aquitaine, France, 19100
2
Clinique du Vivarais
Aubenas, Auvergne-Rhône-Alpes, France, 07200
3
Clinique du Val d'Ouest
Écully, Auvergne-Rhône-Alpes, France, 69130
4
Cabinet de consultation
Évreux, Eure, France, 27000