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

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. 3 versions Re-verified since Jun 13, 2022, no change to tracked fieldsv5-v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  3. Eligibility criteria shortened, about 33 wordsv3
  4. Secondary endpoints: 5 to 7v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04301622
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Knee Osteoarthritis, Traumatic Arthritis of Knee, Avascular Necrosis, Degenerative Joint Disease of Knee, Rheumatoid Arthritis of Knee, Correction of Functional Deformity
Related terms Osteoarthritis, Knee, Osteonecrosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov