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Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. 3 versions Re-verified since Jun 6, 2023, no change to tracked fieldsv6-v8
  2. Study sites: 1 to 2v5
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2021 to Jan 27, 2022
    v4
  4. Start date: Aug 2021 to Dec 2021v3
  5. Eligibility criteria expanded, about 189 wordsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.
Trial Details
NCT Number NCT04816773
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Joint Diseases, Osteoarthritis, Arthritis Knee, Avascular Necrosis
Related terms Joint Diseases, Osteoarthritis, Osteonecrosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov