Arthroplasty Cements Outcomes - A Post-market Follow-up

Launched by TEKNIMED · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Arthroplasty Cements Outcomes - A Post-market Follow-up," is studying the safety and effectiveness of specific bone cements and a cement restrictor used in joint replacement surgeries. These products, made by Teknimed, have been used for over 20 years, and the aim of this study is to gather more real-world data to confirm their performance and safety as patients receive treatment in different healthcare settings.

To participate, you must be at least 18 years old and have either had or be scheduled for a joint replacement surgery using one of Teknimed's products. The study is open to all genders, and patients will be followed up according to the usual care practices of their medical facility. Before joining, you'll need to provide consent for your clinical information to be used. If you are pregnant, under legal guardianship, or unable to follow the study guidelines, you won't be eligible. Overall, this study seeks to ensure that these long-standing products continue to meet safety and effectiveness standards for patients needing joint replacement surgery.

Gender

ALL

Eligibility criteria

• 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)