NCT02351414

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: MicroPort Orthopedics Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.

Conditions

• Joint Disease

Interventions

Type	Name	Description
DEVICE	Total Knee Arthroplasty (EVOLUTION®)

Timeline

• Start date: 2015-06-15
• Primary completion: 2027-06-01
• Completion: 2028-12-01
• First posted: 2015-01-30
• Last updated: 2022-10-13

Locations

5 sites across 5 countries: United States, Belgium, Canada, Germany, United Kingdom