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

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee; TKA
• Interventions: Procedure: Restricted kinematic alignment; Procedure: Mechanical alignment

• Registration Number: NCT06323577
• Lead Sponsor: Thammasat University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-14
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restricted kinematic alignment	Restricted kinematic alignment	-
Mechanical alignment	Mechanical alignment	-

Primary Outcome Measures

Name	Time	Method
Forgotten joint score	6 weeks, 3months, 6 months, 1 year and 2 years after surgery	Point 0-100 (0 mean worst, 100 mean best)

Secondary Outcome Measures

Name	Time	Method
Modified WOMAC score	6 weeks, 3months, 6 months, 1 year and 2 years after surgery	Point 0-96 (0 mean best, 100 mean worst)
Pain score	every 6 hours for 2 days after surgery then once a day for 2 weeks after surgery then once a week until 3 months after surgery	Using visual analog scale (0-10, 0 mean best, 10 mean worst)
Range of motion	6 weeks, 3months, 6 months, 1 year and 2 years after surgery	Using long arm goniometer (degrees)
Hip knee ankle angle	6 weeks, 3months, 6 months, 1 year and 2 years after surgery	Evaluate by long radiograph (degrees)
Complications	Until 2 years after surgery	For example periprosthetic fracture, infection or aspetic loosening
Incidence of soft tissue releasing	During surgery	Record soft tissue releasing intraoperative

Trial Locations

Locations (1)

Thammasat University; 🇹🇭 Khlong Luang, Pathum Thani, Thailand