EVOLUTION® NitrX™
Research type
Research Study
Full title
Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur with Cruciate Sacrificing Insert
IRAS ID
303535
Contact name
DeAnne Hart
Contact email
Sponsor organisation
MicroPort Orthopedics Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
13 years, 0 months, 1 days
Research summary
This study is conducted to evaluate the safety and effectiveness of MicroPort Orthopaedics' (MPO) primary total knee systems (EVOLUTION® NitrX™). In up to 5 investigational sites, newly or previously implanted subjects will be prospectively followed up. The EVOLUTION® NitrX™ system consists of three components and each of these components will be assessed for component survivorship at 1, 3, 5, 7 and 10 years. In total, 150 primary total knee replacements with EVOLUTION® NitrX™ components will be performed. Subjects will have to visit the hospital 6-7 times based upon timing of implantation at enrollment; Screening, Year 1, Year 3, Year 5, Year 7 and Year 10. Secondary objectives include to assess functional scores, subject satisfaction with their total knee replacement procedure, radiography images and safety and tolerability of the system. The study duration will be 13 years, including a 36 month enrollment period and 10 years of follow-up.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0323
Date of REC Opinion
20 Dec 2021
REC opinion
Further Information Favourable Opinion