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

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

Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 143 to confirmed 63
    • Site details revised
    v5
  3. Secondary endpoints: 5 to 4v4
  4. 2 versions Re-verified since Oct 17, 2019, no change to tracked fieldsv2-v3
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
Trial Details
NCT Number NCT03865667
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Joint Disease
Related terms Joint Diseases
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov