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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator Cemented Femoral Stems

NCT02397746 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2022-12-20

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) European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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.

Conditions

  • Joint Disease

Interventions

DEVICE

total hip arthroplasty implant

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-12-20
Completion
2021-12-20

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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 NCT02397746 on ClinicalTrials.gov