Freedom® 450 and Version 2.0
Research type
Research Study
Full title
Freedom® 450: A prospective, multi-centre, non-comparative, post-market clinical follow-up study to evaluate the survivorship, safety and performance of the Freedom® Total Knee System in United Kingdom
IRAS ID
257462
Contact name
Vikas Salgotra
Contact email
Sponsor organisation
Meril Life Sciences India Pvt. Ltd.
Duration of Study in the UK
11 years, 0 months, 0 days
Research summary
The study design is a prospective, multi-centre, non-comparative, post-market clinical follow-up study of the commercially available Freedom® Total Knee System. This study will enroll 450 subjects treated with Freedom® Total Knee System by indication for end-stage symptomatic primary knee osteoarthritis. The study will be conducted at up to 15 centers in the United Kingdom (UK). All study subjects will undergo consent process, pre-operative clinical and radiographic evaluation prior to their total knee replacement.
The post-operative clinical and radiographic evaluations will be conducted at
8 weeks ± 1week, 1 year ± 1 month, 3 years ± 6 months, 5 years ± 6 months (optional) and 10 years ± 6 months (optional).REC name
West of Scotland REC 5
REC reference
19/WS/0128
Date of REC Opinion
2 Oct 2019
REC opinion
Further Information Favourable Opinion