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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navio™ Robotics-assisted Surgical System | Experimental |
| |
| Conventional, non-robotics-assisted total knee surgical system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navio™ Robotics-assisted Surgical System, LEGION Total Knee System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Range of motion of knee |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satit Thiengwittayaporn, M.D. | Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navamindradhiraj University | Dusit | Bangkok | 10300 | Thailand |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Conventional, LEGION Total Knee System | Device | 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. |
|
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 |
| 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 |
| D012216 |
| Rheumatic Diseases |