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Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
Sponsor: MicroPort Orthopedics Inc.
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
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