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ENROLLING BY INVITATION
NCT04147559

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

Sponsor: MicroPort Orthopedics Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2020-10-21

Completion Date

2033-11-01

Last Updated

2024-03-20

Healthy Volunteers

No

Conditions

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.

Locations (2)

HonorHealth Research Institute

Scottsdale, Arizona, United States

HCA Research Institute, OrthoONE at Swedish Medical Center

Englewood, Colorado, United States