Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-11
Brief Title:
Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
Sponsor:
Corin
Organization:
Corin
Study Overview
Official Title:
Improved Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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 goal of this study is to learn about the effects of soft tissue balancing technology in patients undergoing robotic assisted total knee arthroplasty TKA The main questions it aims to answer are
What is the accuracy of soft tissue balancing in both sensor assisted and non-sensor assisted TKA
What are the outcomes of a cohort of TKA patients who undergo surgery with soft tissue balance technology
Participants will answer health related surveys both before and after their surgery
What is the accuracy of soft tissue balancing in both sensor assisted and non-sensor assisted TKA
What are the outcomes of a cohort of TKA patients who undergo surgery with soft tissue balance technology
Participants will answer health related surveys both before and after their surgery
Detailed Description:
This is a post market multicenter study to determine the effect of the BalanceBot on soft tissue balancing and the effect of robotic-assisted TKA with the BalanceBot on patient reported outcomes measures PROMs PROMs will include knee pain symptoms function during activities of daily living sport and recreation and quality of life from the KOOS VR-12 or PROMIS UCLA activity scale and patient satisfaction
Secondary objectives are
To quantify the frequency and extent of soft tissue releases and bone recuts performed in measured resection femur first and gap balancing tibial first surgical techniques
Determine if any associations exist between patient parameters surgical parameters including final intra-operative balance achieved and patient reported outcomes
Allocation of enrollment is estimated to be 15 standard robotic and 85 BalanceBot The decision to use the BalanceBot or Standard Robotic will be left to the discretion of the surgical team The surgeon will use their preferred technique tibia first or femur first as per their standard of care
During the initial phase of the study standard robotic patients will have their soft tissue balance assessed using the BalanceBot in a blinded fashion The surgeon will be blinded to these BalanceBot measurements which will be recorded by an assistant during the case After this initial phase of the study the BalanceBot will not be used during standard robotic cases The BalanceBot will be used to quantify the final ligament balanced achieved in the BalanceBot cases and also in a subset of standard robotic cases In the standard robotic subset cohort the surgeon will complete the surgery as they would normally including performing any ligament balancing using manual blocks or manual implant trial components as per the standard technique Once the surgeon believes they have sufficiently balanced the knee they will insert the BalanceBot to measure the final balanced achieved The surgeon will be blinded to the BalanceBot measurements at this stage so as not to bias the surgery In the BalanceBot cases the surgeon will have visibility to the onscreen knee balance and force data and can use the data to assist in the ligament balancing process as per the standard BalanceBot technique The standard robotic subset cohort will be enrolled first followed by the BalanceBot cohort such that the use of the BalanceBot does not bias or otherwise influence the standard robotic procedure
The decision to use the BalanceBot or Standard Robotic will be left to the discretion of the surgical team The surgeon will use their preferred technique tibia first or femur first as per their standard of care
Secondary objectives are
To quantify the frequency and extent of soft tissue releases and bone recuts performed in measured resection femur first and gap balancing tibial first surgical techniques
Determine if any associations exist between patient parameters surgical parameters including final intra-operative balance achieved and patient reported outcomes
Allocation of enrollment is estimated to be 15 standard robotic and 85 BalanceBot The decision to use the BalanceBot or Standard Robotic will be left to the discretion of the surgical team The surgeon will use their preferred technique tibia first or femur first as per their standard of care
During the initial phase of the study standard robotic patients will have their soft tissue balance assessed using the BalanceBot in a blinded fashion The surgeon will be blinded to these BalanceBot measurements which will be recorded by an assistant during the case After this initial phase of the study the BalanceBot will not be used during standard robotic cases The BalanceBot will be used to quantify the final ligament balanced achieved in the BalanceBot cases and also in a subset of standard robotic cases In the standard robotic subset cohort the surgeon will complete the surgery as they would normally including performing any ligament balancing using manual blocks or manual implant trial components as per the standard technique Once the surgeon believes they have sufficiently balanced the knee they will insert the BalanceBot to measure the final balanced achieved The surgeon will be blinded to the BalanceBot measurements at this stage so as not to bias the surgery In the BalanceBot cases the surgeon will have visibility to the onscreen knee balance and force data and can use the data to assist in the ligament balancing process as per the standard BalanceBot technique The standard robotic subset cohort will be enrolled first followed by the BalanceBot cohort such that the use of the BalanceBot does not bias or otherwise influence the standard robotic procedure
The decision to use the BalanceBot or Standard Robotic will be left to the discretion of the surgical team The surgeon will use their preferred technique tibia first or femur first as per their standard of care
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?:
False
Is an FDA AA801 Violation?:
None