Status:
ACTIVE_NOT_RECRUITING
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
Lead Sponsor:
MicroPort Orthopedics Inc.
Conditions:
Knee Osteoarthritis
Traumatic Arthritis of Knee
Eligibility:
All Genders
21+ years
Brief 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 comp...
Detailed Description
The objectives of this study are: 1. To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial insert...
Eligibility Criteria
Inclusion
- 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
- Has previously undergone or currently has determined to undergo a primary TKA for any of the following:
- non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
- Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation
Exclusion
- Skeletally immature (less than 21 years of age) at time of implantation
- Has or had an overt infection at the time of implantation
- Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
- Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
- 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
- Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
- Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Unwilling or unable to sign the Informed Consent document
- Has documented substance abuse issues
- Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Currently incarcerated or has impending incarceration
- Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol
Key Trial Info
Start Date :
February 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2032
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04301622
Start Date
February 3 2020
End Date
August 1 2032
Last Update
March 20 2024
Active Locations (1)
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1
Covenant Medical Center
Saginaw, Michigan, United States, 48602