Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307251
• Other study ID #: COA 012/2563
• Status: Completed
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: February 25, 2021

Study information

• Verified date: March 2020
• Source: Navamindradhiraj University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: February 25, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

• Age 50-80 year

• Patients with osteoarthritis who voluntarily participated in the project

Exclusion Criteria:

• Patients with osteoporosis

• History of inflammatory arthroplathy

• Previous fracture or open surgery on the same knee

• Patients with bilateral total knee arthroplasty

• Patients osteoarthritis with revision surgery

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• Navio™ Robotics-assisted Surgical System, LEGION Total Knee System
Robotic TKA uses computer software to convert anatomical information into a virtual patient-specific 3D reconstruction of the knee joint.The surgeon uses this virtual model to plan optimal bone resection, implant positioning, bone coverage, and limb alignment based on the patient's unique anatomy.
• Conventional, LEGION Total Knee System
Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific.

Locations

Country	Name	City	State
Thailand	Navamindradhiraj University	Dusit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical axis	Post-operative Mechanical Alignment; Hip-Knee-Ankle angle; If you divide the knee into quadrants, the ideal mechanical axis would bisect the knee (0), with medial zone (-1) or lateral zone (-1) being within physiologic range. With the notable exception of physiologic varus	Change from baseline mechanical axis at 6 weeks after surgery
Secondary	Knee Society and Knee Society function score	Knee Society and Knee Society function score (minimum 0, maximum 200)	Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
Secondary	Range of motion of knee	Range of motion of knee (minimum 0, maximum 140)	Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery
Secondary	Oxford knee score	Oxford knee score (minimum 0, maximum 48)	Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery