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

Comparison of Functional Outcomes in Restricted Kinematic Alignment and Mechanical Alignment in Robotic Assisted Simultaneous Bilateral Total Knee Arthroplasty. A Randomized Controlled Trial

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06323577

Enrollment

Registered

2024-03-21

Start date

2024-03-14

Completion date

2026-05-31

Last updated

2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee, TKA

Keywords

restrict kinematic alignment, mechanical alignment

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.

Interventions

PROCEDURERestricted kinematic alignment

TKA using restricted kinematic alignment under robotic assisted surgery (MAKO).

PROCEDUREMechanical alignment

TKA using mechanical alignment under robotic assisted surgery (MAKO).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Range of motion	6 weeks, 3months, 6 months, 1 year and 2 years after surgery	Using long arm goniometer (degrees)
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)
Modified WOMAC score	6 weeks, 3months, 6 months, 1 year and 2 years after surgery	Point 0-96 (0 mean best, 100 mean worst)
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
Hip knee ankle angle	6 weeks, 3months, 6 months, 1 year and 2 years after surgery	Evaluate by long radiograph (degrees)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026