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ACTIVE NOT RECRUITING
NCT02351414

Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

Sponsor: MicroPort Orthopedics Inc.

View on ClinicalTrials.gov

Summary

MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Official title: Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2015-06-15

Completion Date

2028-12

Last Updated

2022-10-13

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Total Knee Arthroplasty (EVOLUTION®)

Locations (5)

Illinois Bone & Joint Institute

Morton Grove, Illinois, United States

AZ Maria-Middelares

Ghent, Belgium

The Ottawa Hospital

Ottawa, Ontario, Canada

Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr

Mülheim, Germany

University Hospital Llandough

Penarth, South Glamorgan, United Kingdom