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

NCT04301622 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-03-20

No results posted yet for this study

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.

Conditions

  • Knee Osteoarthritis
  • Traumatic Arthritis of Knee
  • Avascular Necrosis
  • Degenerative Joint Disease of Knee
  • Rheumatoid Arthritis of Knee
  • Correction of Functional Deformity

Interventions

DEVICE

Primary Knee implants

Primary knee arthroplasty

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Principal Investigators

  • Brian de Beaubien, MD · Covenant Medical Center

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2032-02-29
Completion
2032-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04301622 on ClinicalTrials.gov