NCT06321952

Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA

A Comparison of Accuracy and Functional Outcome Between Robotic Assisted Surgery and Gyroscopic Based Instrument in Primary Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Knee Arthropathy

Interventions

Type	Name	Description
DEVICE	ROSA robotic assist TKA	total knee replacement with ROSA robotic assist
PROCEDURE	iassist TKA	total knee replacement with iassist

Timeline

• Start date: 2021-09-17
• Primary completion: 2023-10-22
• Completion: 2024-02-01
• First posted: 2024-03-20
• Last updated: 2024-03-20

Locations

1 site across 1 country: Thailand