Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321952
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2024-02-12
Brief Title:
Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
A Comparison of Accuracy and Functional Outcome Between Robotic Assisted Surgery and Gyroscopic Based Instrument in Primary Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2024-03
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:
A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis Kellgren and Lawrence grade 2-3 The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group Baseline characteristics including age body mass index length of stay and estimated blood loss were recorded The primary outcome measure was the accuracy of the hip knee angle measured by scannogram film preoperatively and postoperatively at 3 months Secondary outcomes included functional outcomes KOOS Oxford knee score EQ-5D-5L range of motion assessed preoperatively and postoperatively at 3 months as well as at 6 months postoperatively
Detailed Description:
Introduction Primary total knee arthroplasty is considered the gold standard treatment for end-stage osteoarthritis of the knee The primary objective of this surgical procedure is to restore mechanical alignment At Siriraj Hospital we employ technology to enhance the accuracy of our surgical procedures The purpose of this study is to compare the accuracy of robotic-assisted surgery ROSA and gyroscope-based surgery in primary total knee arthroplasty
Methods A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis Kellgren and Lawrence grade 2-3 The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group Baseline characteristics including age body mass index length of stay and estimated blood loss were recorded The primary outcome measure was the accuracy of the hip knee angle measured by scannogram film preoperatively and postoperatively at 3 months Secondary outcomes included functional outcomes KOOS Oxford knee score EQ-5D-5L range of motion assessed preoperatively and postoperatively at 3 months as well as at 6 months postoperatively
Methods A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis Kellgren and Lawrence grade 2-3 The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group Baseline characteristics including age body mass index length of stay and estimated blood loss were recorded The primary outcome measure was the accuracy of the hip knee angle measured by scannogram film preoperatively and postoperatively at 3 months Secondary outcomes included functional outcomes KOOS Oxford knee score EQ-5D-5L range of motion assessed preoperatively and postoperatively at 3 months as well as at 6 months postoperatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None