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Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

Study acronym: AMETHYST
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv16
  2. Study sites revised (5)v15
  3. Primary endpoint revised
    • Secondary endpoints: 3 to 5
    v14
  4. 2 versions Re-verified since May 27, 2019, no change to tracked fieldsv12-v13
  5. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study sites revised (5)
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 5 of 5 sites
    v9
  3. Start date: Jun 2015 to Jun 15, 2015v8
  4. Site contacts updated at 1 of 5 sitesv7
  5. Study sites: 4 to 5v6
  6. Enrollment target: 550 to 150
    • Study sites: 3 to 4
    v5
  7. Study sites: 1 to 3v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: May 2027 to Jun 2027
    • Start date: May 2015 to Jun 2015
    • Site details revised
    v3
  9. Start date: Mar 2015 to May 2015
    • Study sites: 0 to 1
    • Primary completion date: Mar 2027 to May 2027
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Trial Details
NCT Number NCT02351414
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Joint Disease
Related terms Ankylosis, Arthritis, Arthritis, Rheumatoid, Joint Diseases, Osteoarthritis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov