Journey II BCS EU Observational Trial

Status Active, not recruiting

Clinical Trial Summary

Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02211794
Study type	Observational
Source	Smith & Nephew, Inc.
Contact
Status	Active, not recruiting
Phase
Start date	January 2014
Completion date	June 2026

View Details

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