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

NCT ID: NCT06321952

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2024-02-01

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.

Conditions

Knee Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ROSA robotic assist TKA

ROSA robotic assist TKA

Group Type: ACTIVE_COMPARATOR

ROSA robotic assist TKA

Intervention Type: DEVICE

total knee replacement with ROSA robotic assist

iassist TKA

iassist TKA

Group Type: ACTIVE_COMPARATOR

iassist TKA

Intervention Type: PROCEDURE

total knee replacement with iassist

Interventions

ROSA robotic assist TKA

total knee replacement with ROSA robotic assist

Intervention Type: DEVICE

iassist TKA

total knee replacement with iassist

Intervention Type: PROCEDURE

Other Intervention Names

iassist TKA

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Siriraj Hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

GTanareesuchoti

Identifier Type: -

Identifier Source: org_study_id