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Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. 4 versions Re-verified since Oct 12, 2022, no change to tracked fieldsv7-v10
  2. Eligibility criteria expanded, about 65 wordsv6
  3. Start date: Jun 11, 2020 to Sep 30, 2020
    • Eligibility criteria expanded, about 16 words
    v5
  4. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2020 to Jun 11, 2020
    v4
  5. Start date: May 1, 2020 to Jul 1, 2020v3
  6. Primary completion date: Jan 1, 2030 to May 1, 2033
    • Start date: Jan 1, 2020 to May 1, 2020
    • Study completion date: Jan 1, 2033 to Nov 1, 2033
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.
Trial Details
NCT Number NCT04145401
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Knee Osteoarthritis
Related terms Arthritis, Rheumatoid, Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov