Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 80 years old?
Source: NCT06835621, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Thammasat University
- Trial code
- NCT06835621
- Record updated
- 19 February 2025
- Original description
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:Read full original descriptionShow less
Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty. A Randomized Controlled Trial.
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.
Inclusion: 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.
Exclusion: Previous knee surgery; Infection around the knee; Valgus deformity; KL grading > 3 on contralateral knee; Unable or difficulty for walking due to comorbidities; BMI > 40 kg/m2.