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

NCT04147559 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-03-20

No results posted yet for this study

Summary

Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.

Conditions

  • Joint Diseases

Interventions

DEVICE

Total Hip Arthroplasty Implant

Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads.

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Assini, MD · OrthoOne at Swedish Medical Center

  • Judd Cummings, MD · HonorHealth Research Institute

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2033-05-01
Completion
2033-11-01
FDA Device
Yes

Countries

  • United States

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 NCT04147559 on ClinicalTrials.gov