The goal of this clinical trial is to learn if restricted inverse kinematic alignment total knee arthroplasty (restricted iKA TKA) improves functional recovery compared to adjusted mechanical alignment total knee arthroplasty (aMA TKA) in patients undergoing unilateral robotic-assisted total knee arthroplasty by comparing performance-based outcome, 2-minute walk test (2MWT) as a primary outcome. This trial will also assess other outcomes including satisfaction, patient-reported functional outcomes, range of motion, visual analog scale for pain and complication of both techniques. The main question aims to answer is:
In unilateral robotic-assisted total knee arthroplasty, dose Restricted iKA technique provide better postoperative performance-based outcome compared to aMA technique?
Researchers will compare restricted iKA and aMA technique to determine which technique offers better acceleration in functional recovery and patient satisfaction.
Participants will:
After randomization, participants will allocate to either restricted iKA or aMA technique for unilateral robotic-assisted total knee arthroplasty.
Attend follow-up visits for assessments of 2-minute walk test (Primary outcome), Time up and go test (TUG), VAS for pain, ROM and complete patient-reported functional outcome questionnaires regarding knee function and satisfaction at regular intervals.
Age 50 - 80 years old
Diagnosed with primary OA knee and indicated for unilateral total knee arthroplasty with MAKO robotic-assisted knee replacement system
ASA classification I-II
Valgus deformity
KL grading > 3 on contralateral knee
Unable or difficulty for walking due to comorbidities
BMI > 40 kg/m2
Parallel
Restricted inverse kinematic alignment Total Knee Arthroplasty
Procedure/SurgeryRestricted inverse kinematic alignment (restricted iKA) total knee arthroplasty is an alignment technique of total knee replacement surgery, aim to maintain the native coronal alignment within a HKA angle safe zone of 177° to 183°. This technique aims to 'resurface' the femur maintaining the native femoral joint line obliquity, with the flexion and extension gaps balanced by adjusting the tibial resection first. It is considered a more personalized approach because it aims to replicate the knee's pre-arthritic alignment and movement, believing that each patient's knee has a unique alignment.
Adjusted Mechanical alignment Total Knee Arthroplasty
Procedure/SurgeryThe adjusted Mechanical Alignment (aMA) technique is an adaptation of the conventional MA technique but with undercorrection of constitutional coronal deformity, within a limit of ± 3°. The femoral resection is adjusted to preserve mild constitutional deformity and/or reduce more severe deformity while leaving the tibial component mechanically aligned. The tibial component was positioned with the aim to be perpendicular (90°) to the mechanical tibial axis.
2-minute walk test
The 2-minute walk test (2mwt) is a performance-based test that evaluates functional recovery after total knee arthroplasty (TKA) by measures the distance a person can walk in two minutes (meters) and has been validated as performance-based test with responsiveness properties. Being simple and easy to perform, it can be used routinely in clinical practice to evaluate functional recovery after TKA.
Time up and go test
The Timed Up and Go test (TUG) are simple, quick, and can be applied in a short time as part of the routine medical examination. They were shown to be reliable and valid tests in many patient groups including postoperative performance-based outcome for patients undergone TKA.
modified WOMAC scale for knee pain (Thai version)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used questionnaire for assessing pain, stiffness, and functional limitation in patients with osteoarthritis, particularly in the knee and hip joints. The modified WOMAC scale adapts the original WOMAC to better suit specific populations or clinical settings. In this study, we use the modified WOMAC scale for knee pain Thai version to assess the pre and post operative functional outcome.
Thai version of the Forgotten Joint Score
This score aims for evaluation of joint awareness in everyday life, which is one of the aspects to evaluate the outcome and the ability to forget the artificial joint, is claimed as the ultimate goal resulting in maximum patient satisfaction. The Thai language version of the FJS had high level of internal consistency and was proved to be a reliable tool for evaluating knee arthroplasty patients in Thailand. The low ceiling effect characteristic of the score can help the surgeon to detect small difference in the good and excellent outcomes after knee arthroplasty.
Oxford knee score
The Oxford Knee Score (OKS) is a widely used patient-reported outcome measure designed to assess the function and quality of life of individuals with knee problems, particularly those undergoing knee surgery, such as total knee arthroplasty. It focuses specifically on how knee-related issues affect daily activities and overall well-being. (Thai version is available on the official website of the Oxford knee score website)
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