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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem

NCT03865667 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2023-04-28

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 Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Conditions

  • Joint Disease

Interventions

DEVICE

PROFEMUR® Preserve Femoral Stem

Total Hip Total Hip Arthroscopy

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Principal Investigators

  • Manel Ribas, MD · Hospital Universitari Dexeus

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2032-01-01
Completion
2032-01-01

Countries

  • Spain

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 NCT03865667 on ClinicalTrials.gov