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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems

NCT02314611 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 154

Last updated 2024-01-09

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® Gladiator HA Coated Modular Femoral Stem

Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Principal Investigators

  • Philippe Van Overschelde, MD · Algemeen Ziekenhuis Maria-Middelares (Gent, Belgium)

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-11-30
Completion
2023-11-30

Countries

  • Belgium

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 NCT02314611 on ClinicalTrials.gov