Arthroplasty Cements Outcomes - A Post-market Follow-up
Recruiting
Observational Study
Arthroplasty
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
1,050 (estimated)
Sponsor
Teknimed · Industry
Who this trial is looking for
This trial is looking for patients who have had or are considering arthroplasty surgery using Teknimed products. Participating involves sharing your clinical data about the procedure to help assess the safety and effectiveness of these products.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I am willing to share my clinical data for this study.
I have had arthroplasty surgery with Teknimed cement from January 1, 2016, onward.
I am being considered for an arthroplasty procedure with Teknimed cement.
You may not be able to join if
I am under trusteeship or guardianship.
I am pregnant.
I cannot follow the study protocol.
My health condition is poor, according to my doctor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 bee…
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.
Trial Locations
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City
State
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Status
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…
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)
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