Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03576573 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv8
  2. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Interventions: PROFEMUR Xm, PROFEMUR Gladiator Plasma Stems , PROCOTYL® C (Device) to PROCOTYL® C (Device)
    • Eligibility criteria shortened, about 22 words
    v5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2019 to Mar 27, 2019
    • Site details revised
    v3
  2. Primary and study completion dates: Dec 2029 to Dec 2032v2 Show 4 more changesShow less
    • Start date: Sep 2018 to Mar 2019
    • Interventions: PROFEMUR® Xm Femoral Stems or PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® C Acetabular Components (Device) to PROFEMUR Xm, PROFEMUR Gladiator Plasma Stems , PROCOTYL® C (Device)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 2 to 3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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 NCT03576573
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