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

Knee Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06321952
• Other study ID #: GTanareesuchoti
• Status: Completed
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 1, 2024
• Est. primary completion date: October 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

Device:
• ROSA robotic assist TKA
total knee replacement with ROSA robotic assist

Procedure:
• iassist TKA
total knee replacement with iassist

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument	functional outcomes (range of motion)	preoperative and postoperative 3months and 6months