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A Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Trial to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System
Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.
Multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (CRF's). Total study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing the clinical outcome is planned after 5 years.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 1, 2014
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2026
Last Updated
January 31, 2024
175
ACTUAL participants
data collection
OTHER
Lead Sponsor
Smith & Nephew Orthopaedics AG
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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