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Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components

NCT02149667 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2023-06-07

No results posted yet for this study

Summary

Sponsor 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 MEDDEV 2.12/2 rev 2.

Conditions

  • Joint Disease

Interventions

DEVICE

total hip arthroplasty implant

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Beaule, MD · Ottawa Hospital Research Institute

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Canada

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 NCT02149667 on ClinicalTrials.gov