Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617338
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty TKA based on the non-arthritic side will give the patient better overall alignment function and improved results compared to basing our implant alignment and positioning off the arthritic side which is currently the traditional method
The main questions it aims to answer are
Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side
What are the similarities or differences between study arms with respect to final implant alignment and positioning angles Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty RA-TKA with normal contralateral knee Based on preoperative CT imaging the researchers will use normal contralateral side joint numbers as the target alignment for one group Experimental arm and utilize the traditional method for the other group Active comparator arm Clinical outcomes and patient-reported outcome measures PROMs will be compared between groups
Participants will
Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively
Follow-up in the clinic at 2 weeks 6 weeks and 1-year postoperatively per standard-of-care for x-ray and clinical evaluation
Complete postop questionnaires PROMs at the prescribed follow-up intervals
The main questions it aims to answer are
Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side
What are the similarities or differences between study arms with respect to final implant alignment and positioning angles Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty RA-TKA with normal contralateral knee Based on preoperative CT imaging the researchers will use normal contralateral side joint numbers as the target alignment for one group Experimental arm and utilize the traditional method for the other group Active comparator arm Clinical outcomes and patient-reported outcome measures PROMs will be compared between groups
Participants will
Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively
Follow-up in the clinic at 2 weeks 6 weeks and 1-year postoperatively per standard-of-care for x-ray and clinical evaluation
Complete postop questionnaires PROMs at the prescribed follow-up intervals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None