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Clinical Trial Summary

Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation).

Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03293719
Study type Observational
Source Peter Brehm GmbH
Contact Christian E. Berger, Prof.
Phone +43 (0)1 288
Email christian.berger@wienkav.at
Status Recruiting
Phase
Start date March 20, 2018
Completion date April 1, 2025

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