Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 3:54 PM
Study NCT ID:
NCT03292003
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2017-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
Detailed Description:
The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: