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Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. 2 versions Re-verified since Apr 14, 2023, no change to tracked fieldsv15-v16
  2. Trial status: Enrolling by Invitation to Active, Not Recruitingv14
  3. Re-verified, no change to tracked fieldsv13
  4. Study description expanded, about 80 wordsv12
  5. 3 versions Re-verified since Dec 18, 2017, no change to tracked fieldsv9-v11
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 8 wordsv8
  2. 3 versions Re-verified since Apr 29, 2016, no change to tracked fieldsv5-v7
  3. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 NCT02285842
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Joint Disease
Related terms Ankylosis, Arthritis, Rheumatoid, Joint Diseases, Osteoarthritis, Osteonecrosis
Enrollment 143 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov