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Active, not recruiting Observational

Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur

NCT04301622 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2020-02-03
Last updated
2024-03-20

Condition(s) studied

Knee OsteoarthritisTraumatic Arthritis of KneeAvascular NecrosisDegenerative Joint Disease of KneeRheumatoid Arthritis of KneeCorrection of Functional Deformity

Investigational drug(s) / intervention(s)

Primary Knee implants

Primary Knee implants: Primary knee arthroplasty

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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 2. 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. 3. Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation Exclusion Criteria: 1. Skeletally immature (less than 21 years of age) at time of implantation 2. Has or had an overt infection at the time of implantation 3. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation 4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation 5. 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 6. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques 7. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol 8. Unwilling or unable to sign the Informed Consent document 9. Has documented substance abuse issues 10. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study 11. Currently incarcerated or has impending incarceration 12. 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

Primary outcome measure(s)

  • Individual component survivorship — 10 years post-operative
    Individual component survivorship for tibial base, femoral, and tibial CS insert at specified intervals out to 10 years follow-up.

Trial sites (1)

FacilityCityRegionStatus
Covenant Medical Center Saginaw Michigan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04301622 on ClinicalTrials.gov ↗ ← All trials in the USA