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

Not Applicable

Completed

• Conditions: Knee Arthropathy
• Interventions: Device: ROSA robotic assist TKA; Procedure: iassist TKA

• Registration Number: NCT06321952
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2021-09-17
• Primary Completion: 2023-10-22
• Study Completion: 2024-02-01
• Study First Submitted: 2024-02-12
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• primary osteoarthritis knee with indicated for total knee replacement
• age equal or more than 55 years old

Exclusion Criteria

• revision surgery
• deformity greater than 15º
• Intra/Post operative complication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROSA robotic assist TKA	ROSA robotic assist TKA	ROSA robotic assist TKA
iassist TKA	iassist TKA	iassist TKA

Primary Outcome Measures

Name	Time	Method
accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument	preoperative and postoperative 3months	accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months

Secondary Outcome Measures

Name	Time	Method
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument	preoperative and postoperative 3months and 6months	functional outcomes (range of motion)

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand