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Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components

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

Record History

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  1. 2 versions Re-verified since Apr 14, 2023, no change to tracked fieldsv16-v17
  2. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 143 to confirmed 48
    v15
  3. Re-verified, no change to tracked fieldsv14
  4. Study description expanded, about 124 wordsv13
  5. 3 versions Re-verified since Dec 18, 2017, no change to tracked fieldsv10-v12
Show 8 earlier versionsHide 8 earlier versions
  1. Eligibility criteria expanded, about 8 wordsv9
  2. 3 versions Re-verified since Apr 29, 2016, no change to tracked fieldsv6-v8
  3. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date: Oct 2014 to Dec 2014
    • Primary completion date: Oct 2027 to Dec 2027
    • Study completion date: Oct 2028 to Dec 2028
    • Site details revised
  6. Start date: Jul 2014 to Oct 2014v2 Show 4 more changesShow less
    • Primary completion date: Jul 2027 to Oct 2027
    • Study completion date: Jul 2028 to Oct 2028
    • Eligibility criteria shortened, about 69 words
    • Secondary endpoints: details revised at 1 of 1 entry
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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) 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 MEDDEV 2.12/2 rev 2.
Trial Details
NCT Number NCT02149667
Lead Sponsor MicroPort Orthopedics Inc.
Conditions
(from sponsor)		 Joint Disease
Related terms Ankylosis, Arthritis, Rheumatoid, Joint Diseases, Osteoarthritis, Osteonecrosis
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov