Osteoarthritis, Knee
Conditions
Brief 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
Interventions
DEVICENavio™ 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.
DEVICEConventional, 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.
Sponsors
Navamindradhiraj University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical axis | Change from baseline mechanical axis at 6 weeks after surgery | 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 \<age 2 and physiologic valgus \<age 6, medial or lateral zones 2 or 3 would likely manifest symptoms and gait disturbance and thereby warrant surgical intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society and Knee Society function score | Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery | Knee Society and Knee Society function score (minimum 0, maximum 200) |
| Range of motion of knee | Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery | Range of motion of knee (minimum 0, maximum 140) |
| Oxford knee score | Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery | Oxford knee score (minimum 0, maximum 48) |
Countries
Thailand
Outcome results
None listed