Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA

Thammasat University Hospital

Status: Enrolling

Conditions: TKA; Osteoarthritis, Knee

Treatments: Procedure: Mechanical alignment; Procedure: Restricted kinematic alignment

Study type: Interventional

Funder types: Other

Identifiers

NCT06323577

TUH rKA vs MA TKA

Details and patient eligibility

About

The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.

The main question[s] it aims to answer are:

• Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?
• Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40-80 years
• Diagnosis bilateral primary osteoarthritis of knee joint and undergo simultaneous bilateral total knee arthroplasty
• ASA classification I-II

Exclusion criteria

• Valgus deformity
• BMI > 40kg/m2
• History of previous knee surgery
• Active infection of the knee joint

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Restricted kinematic alignment

Experimental group

Treatment:

Procedure: Restricted kinematic alignment

Mechanical alignment

Active Comparator group

Treatment:

Procedure: Mechanical alignment