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Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected.
Thia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical alignment | Experimental |
| |
| Functional alignment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical alignment | Other | Goal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic outcomes : Hip-knee-ankle angle | angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond | pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks |
| Radiographic outcomes : Tibial plafond inclination | angle in degree between subchondral plate of distal tibial articular surface and vertical axis | pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks |
| Radiographic outcomes :Talar inclination | angle in degree between talar dome and vertical axis | pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks |
| Radiographic outcomes : Tibiotalar tilt angle | angle in degree between subchondral plate of distal tibial articular surface and talar dome | pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS) | a questionnaire assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. | pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Other outcomes : soft tissue release | intra-operative soft tissue release (medial collateral ligament release or others structure around knee) report with Yes (soft tissue release) or No (no soft tissue release) | intraoperative |
| Other outcomes : operative time |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Ratchathewi | Bangkok | 10400 | Thailand |
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| Functional alignment | Other | Goal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity. |
|
| Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score | evaluation of the clinical status of the ankle-hindfoot, both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points. | pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks |
| Quality of Life score : EQ-5D-5L | assess patient five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, Index scores range from -0.42 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0. | pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks |
| Forgotten Joint Score | consists of 12 questions and is transform on a 0-100 scale.The higher the score, the less the patient is aware of their affected joint when performing daily activities | pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks |
measured in minutes from skin incision to complete of skin suture |
| intraoperative |
| Other outcomes : blood loss | record in millilitre measured from Radivac drain | post operative with in 2 days |
| Other outcomes : pain score (Visual analog scale) | score from 0-10 (0 was no pain, 10 was worst pain ) | post-operative at 2,4,8,12 weeks |
| Other outcomes : Range of knee motion | record in total degree of knee motion | post-operative at 2,4,8,12 weeks |
| complications | Yes (complications) or No ( no complications) if yes, will specified the complications complication such as bone fracture, wound dehiscence, surgical site infection, periprosthetic infection ,pulmonary embolism or other adverse outcomes that may or may not directly associated with the operation. | post-operative at 2,4,8,12 weeks |