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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Enrolling by Invitation to Active, Not Recruitingv16
  2. 4 versions Re-verified since Apr 15, 2021, no change to tracked fieldsv12-v15
  3. Study description expanded, about 124 wordsv11
  4. 3 versions Re-verified since Dec 18, 2017, no change to tracked fieldsv8-v10
  5. Eligibility criteria expanded, about 8 wordsv7
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Dec 13, 2016, no change to tracked fieldsv5-v6
  2. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Oct 2027 to Nov 2027
    • Study completion date: Oct 2028 to Nov 2028
    • Start date: Oct 2014 to Nov 2014
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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 NCT02239783
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