MedTrace Logo

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

NCT02314702 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2022-10-13

No results posted yet for this study

Summary

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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 MEDDEV 2.12/2 rev 2.

Conditions

  • Joint Disease

Interventions

DEVICE

PROFEMUR® L Revision Femoral Stem

Revision Total Hip Arthroplasty

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-04
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • United Kingdom

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 NCT02314702 on ClinicalTrials.gov