Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06062615
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-09-25
Brief Title:
Robotic Assisted TKA
Sponsor:
Rothman Institute Orthopaedics
Organization:
Rothman Institute Orthopaedics
Study Overview
Official Title:
Randomized Pilot Study Investigating Early Functional Outcomes With the Use of Robotic Assisted Versus Conventional Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2024-04
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:
As an intraoperative tool a modern robotic total knee arthroplasty TKA system should be able to identify a patients native femoral and tibial anatomy as well as assess ligament tension and gap balance The surgeon in real time is then able to develop and execute a patient specific plan in terms of component size alignment and rotation In our institution we have begun to use the OMNIBotics Knee system Corin which utilizes an active motorized knee spacer BalanceBot to objectively measure ligament tension and gap balance after the tibia has been cut and its alignment confirmed This information is then processed through the OMNIbotics computer algorithm to appropriately size align and rotate the femur component to balance the flexion and extension gaps The purpose of this study is to perform a randomized pilot study looking for an effect on early functional outcomes comparing robotic assisted TKA RATKA versus conventional TKA technique
Detailed Description:
None
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?:
None