Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-06 @ 5:49 AM
Study NCT ID:
NCT03317834
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Navio With Total Knee Arthroplasty
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2023-06
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 purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments. An additional study purpose is to document clinical and patient-reported outcomes in subjects receiving TKA with the Navio ™ system.
Detailed Description:
Total Knee Arthroplasty (TKA) has become an effective and reliable treatment for arthritis of the knee (1). TKA is associated with low morbidity and mortality, and its effectiveness in reducing joint pain and improving range of motion is well established. In 2014, over 750,000 knee replacements were performed in the US (2).
A significant innovation in TKA has been the introduction of computer navigation and robotic-assisted surgery (3). One such technology is the Navio™ Robotic-assisted Surgical System. This system is a semi-autonomous image-free system. During the surgery, the surgeon maps the condylar landmarks and determines alignment indices to define the volume and orientation of bone to be removed. The tools to remove the bone and place the implants are controlled and manipulated by the surgeon with the guidance of a 3-dimensional digital map of the surgical surface.
Originally the Navio™ system was launched for use in unicondylar knee replacement only. To date, there have been over 1000 unicondylar knee replacement surgeries using the system. In 2017, Smith \& Nephew Inc. expanded the indications for the Navio™ system to include TKA. The purpose of this multicenter, prospective study is to evaluate outcomes associated with this new indication.
A significant innovation in TKA has been the introduction of computer navigation and robotic-assisted surgery (3). One such technology is the Navio™ Robotic-assisted Surgical System. This system is a semi-autonomous image-free system. During the surgery, the surgeon maps the condylar landmarks and determines alignment indices to define the volume and orientation of bone to be removed. The tools to remove the bone and place the implants are controlled and manipulated by the surgeon with the guidance of a 3-dimensional digital map of the surgical surface.
Originally the Navio™ system was launched for use in unicondylar knee replacement only. To date, there have been over 1000 unicondylar knee replacement surgeries using the system. In 2017, Smith \& Nephew Inc. expanded the indications for the Navio™ system to include TKA. The purpose of this multicenter, prospective study is to evaluate outcomes associated with this new indication.
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?: