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Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. 3 versions Re-verified since Jun 6, 2023, no change to tracked fieldsv8-v10
  2. Study sites: 1 to 2v7
  3. Enrollment target: 75 to 150v6
  4. Start date: Jun 17, 2020 to Oct 21, 2020v5
  5. 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 17, 2020
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: May 1, 2020 to Jul 1, 2020v3
  2. Primary completion date: Jan 2030 to May 1, 2033
    • Start date: Jan 2020 to May 1, 2020
    • Study completion date: Jan 2033 to Nov 1, 2033
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is 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 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.
Trial Details
NCT Number NCT04147559
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Joint Diseases
Related terms Ankylosis, Joint Diseases, Osteoarthritis, Osteonecrosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov