Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty.

ConditionsOA KneeTKA
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorThammasat University

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Valgus deformity

KL grading > 3 on contralateral knee

Unable or difficulty for walking due to comorbidities

BMI > 40 kg/m2

Trial design

Treatments tested in this trial

  • Restricted inverse kinematic alignment Total Knee Arthroplasty
  • Adjusted Mechanical alignment Total Knee Arthroplasty

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

2

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Medicine, Thammasat University Status unavailable 12120, Klongluang, Changwat Pathum ThaniThailandThailand
Faculty of Medicine, Thammasat University Status unavailable 12120, Klongluang, Changwat Pathum ThaniThailandThailand

Sponsors and collaborators