Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-07 @ 7:44 PM
Study NCT ID:
NCT03072459
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2017-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Retrospective Study of the Navio Robotic-assisted Surgical System
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
A Retrospective Study of the Navio™ Robotic-assisted Surgical System
Status:
COMPLETED
Status Verified Date:
2021-12
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:
NAVIO
Brief Summary:
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
Detailed Description:
Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: