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PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

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

Record History

  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 143 to confirmed 121
    v12
  2. 5 versions Re-verified since Jun 8, 2018, no change to tracked fieldsv7-v11
  3. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2017 to Jun 16, 2017
    • Primary and study completion dates: Nov 2027 to Jun 2027
    • Site details revised
    v5
  5. Start date: Nov 2016 to Feb 2017
    • Primary and study completion dates: Aug 2027 to Nov 2027
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Site contact updatedv3
  2. Start date: Aug 2016 to Nov 2016v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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 the medial device directives (MEDDEV) 2.12/2 rev 2.
Trial Details
NCT Number NCT02823834
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Joint Disease
Related terms Ankylosis, Arthritis, Rheumatoid, Joint Diseases, Osteoarthritis, Osteonecrosis
Enrollment 121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov