Journey II™ CR total Knee System
Research type
Research Study
Full title
A Prospective, Non-randomized, Single Cohort, Multicenter Study to Evaluate the Clinical Outcomes of Total Knee Arthroplasty (TKA) Using the JOURNEY™ II CR Total Knee System
IRAS ID
202088
Contact name
Esvanhnelly Podany
Contact email
Sponsor organisation
Smith & Nephew, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 24 days
Research summary
The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY II CR Total Knee System in subjects with degenerative knee disease. Participation in this study will continue for 10 years after the date of surgery. The study will involve several questionnaires (EQ-5D, 2011 KSS, and SAPSS) to record data on functional recovery and quality of life as well as other outcome measures such as physical therapy sessions, discharge destinations/length of stay, unscheduled professional visits, concomitant medications, 30-60 and 90 day hospital re-admission rates and safety endpoints. Participating subjects will receive preoperative and surgery assessments and will be followed up at the following intervals; 3 months, 1 year, 2 years, 5 years and 10 years. The JOURNEY II CR Total Knee System is approved for the treatment of degenerative knee disease and is a commercially available product on the market (non-investigational).
REC name
London - Stanmore Research Ethics Committee
REC reference
16/LO/1533
Date of REC Opinion
20 Oct 2016
REC opinion
Further Information Favourable Opinion