Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria
* subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing
* subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)
* subject is of legal age to consent, agrees to consent to and to follow the study visit schedule, by signing the EC approved informed consent form
Exclusion Criteria:
* age \> 75 years
* conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
* subject has inadequate bone stock to support the device
Primary outcome measure(s)
Revision for any reason — 10Years The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. "Success" is defined as 10 year survival of the study device without revision for any reason.
Trial sites (5)
Facility
City
Region
Status
UZ Gent
Ghent
Belgium
University of Modena and Reggio Emilia
Modena
Italy
Sint Maartenskliniek
Nijmegen
Netherlands
Martina Hansens Hospital
Sandvika
Norway
North Hampshire Hospital
Basingstoke
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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