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Clinical Trials in Italy / NCT02211794
Active, not recruiting Observational

Journey II BCS EU Observational Trial

NCT02211794 · tracked via the Priya Life Science Italy tracker
Sponsor
Smith & Nephew Orthopaedics AG
Phase
Observational
Started
2014-02-05
Last updated
2026-09-25

Condition(s) studied

Degenerative Joint Disease

Investigational drug(s) / intervention(s)

data collection

Study summary

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)

FacilityCityRegionStatus
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.

View NCT02211794 on ClinicalTrials.gov ↗ ← All trials in Italy