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

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 Overview

• Status: Completed
• Conditions: Knee Arthropathy
• Intervention / Treatment: Device: ROSA robotic assist TKA; Procedure: iassist TKA

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ROSA robotic assist TKA	Device: ROSA robotic assist TKA; total knee replacement with ROSA robotic assist; Other Names: iassist TKA
Active Comparator: iassist TKA	Procedure: iassist TKA; total knee replacement with iassist

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument	functional outcomes (KOOS score) score 0-100 in each domain of 4 domains 0=worst, 100=good	preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument	functional outcomes (Oxford knee score) score 0-48 0=worst, 48=good	preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument	functional outcomes (EQ-5D-5L) score 5-25, score5=good, 25=worst	preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument	functional outcomes (range of motion)	preoperative and postoperative 3months and 6months

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): October 22, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: GTanareesuchoti

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No