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PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

NCT02507258 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-06-07

No results posted yet for this study

Summary

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) and resurfacing components marketed in the European Union (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 the medial device directives (MEDDEV) 2.12/2 rev 2.

Conditions

  • Joint Disease

Interventions

DEVICE

PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell

PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Principal Investigators

  • Gérard Giordano, MD · Hopital Joseph Ducuing

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02507258 on ClinicalTrials.gov