Arthroplasty Cements Outcomes - A Post-market Follow-up
ConditionArthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTeknimed
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Cemented joint arthroplasty
Treatment groups
1,050 Participants
are divided into 21 treatment groups21
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov