EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol

Recruiting Observational Study
Joint Diseases
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.
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At a Glance
Age
21 and older
Sex
Any
Study type
Observational
Participants needed
45 (estimated)
Sponsor
MicroPort Orthopedics Inc. · Industry
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About This Trial

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert) 2. Decision t…
Contacts

JoAnna-Marie N Becker, BS

+1 901 290 5280

joannamarie.becker@ortho.microport.com

CONTACT

Pietro Randelli, Prof

+39-335-5292-622

pietro.randelli@unimi.it

CONTACT