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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

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

Record History

  1. 2 versions Re-verified since Oct 4, 2021, no change to tracked fieldsv14-v15
  2. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 26
    v13
  3. Re-verified, no change to tracked fieldsv12
  4. Start date: Sep 2015 to Sep 4, 2015v11
  5. 2 versions Re-verified since Jun 8, 2018, no change to tracked fieldsv9-v10
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v8
  2. 4 versions Re-verified since Sep 12, 2016, no change to tracked fieldsv4-v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2015 to Sep 2015
    • Site details revised
    v3
  4. Start date: Apr 2015 to Oct 2015
    • Primary completion date: Apr 2026 to Oct 2026
    • Study completion date: Apr 2027 to Oct 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing 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 NCT02314702
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Joint Disease
Related terms Ankylosis, Arthritis, Rheumatoid, Joint Diseases, Osteoarthritis, Osteonecrosis
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov