MedTrace Logo

PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

NCT02823834 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2022-07-08

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) 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 the medial device directives (MEDDEV) 2.12/2 rev 2.

Conditions

  • Joint Disease

Interventions

DEVICE

PROFEMUR® Gladiator Plasma Femoral Stems

THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Principal Investigators

  • Jose Pimienta · Elbe Kliniken Buxtehude

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Germany

Study Locations

More Related Trials

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 NCT02823834 on ClinicalTrials.gov