Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284824
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-02-22
Brief Title:
Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems
Sponsor:
Southeast Orthopedic Specialists
Organization:
Southeast Orthopedic Specialists
Study Overview
Official Title:
Prospective Randomized Single-center Study Comparing the Stryker MAKO Robotic-Arm Assisted Total Knee Arthroplasty and the DePuy VELYS Robotic-Assisted Solution for Total Knee Arthroplasty
Status:
NOT_YET_RECRUITING
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:
The goal of this prospective study is to compare two different knee replacement robots This study will look at patient reported outcome measures and data collected during the operation The main questions this study aims to answer include
Will the patient reported outcomes differ between the two groups
Will the intraoperative data differ between the two groups Participants will undergo total knee replacement with one of the two robots complete standardized surveys and have x-rays taken
Will the patient reported outcomes differ between the two groups
Will the intraoperative data differ between the two groups Participants will undergo total knee replacement with one of the two robots complete standardized surveys and have x-rays taken
Detailed Description:
The purpose of this study is to compare two different total knee arthroplasty TKA robotic assisted RA devices This study will compare patient reported outcome measures prior to and after surgery These surveys will be used determine if there are differences in patient recovery after TKA depending on the robot used Radiographs will also be taken and used to compare component positioning Intraoperative data will be collected to compare OR efficiency of the two systems
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