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ACTIVE NOT RECRUITING
NCT04301622

Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur

Sponsor: MicroPort Orthopedics Inc.

View on ClinicalTrials.gov

Summary

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.

Official title: Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur With Cruciate Sacrificing Inserts

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2020-02-03

Completion Date

2032-08

Last Updated

2024-03-20

Healthy Volunteers

No

Interventions

DEVICE

Primary Knee implants

Primary knee arthroplasty

Locations (1)

Covenant Medical Center

Saginaw, Michigan, United States