Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur (NCT04301622) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
United States150 participantsStarted 2020-02-03
Plain-language summary
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® CS/CR Porous Femur, EVOLUTION® CS Tibial Insert, and EVOLUTION® BIOFOAM® Tibia and modular keel
âś“. Has previously undergone or currently has determined to undergo a primary TKA for any of the following:
âś“. Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation
Exclusion criteria
âś•. Skeletally immature (less than 21 years of age) at time of implantation
âś•. Has or had an overt infection at the time of implantation
âś•. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
âś•. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
âś•. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
âś•. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
âś•. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol