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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Knee TKA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Restricted kinematic alignment

Group Type EXPERIMENTAL

Restricted kinematic alignment

Intervention Type PROCEDURE

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

Mechanical alignment

Group Type ACTIVE_COMPARATOR

Mechanical alignment

Intervention Type PROCEDURE

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

Interventions

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Restricted kinematic alignment

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

Intervention Type PROCEDURE

Mechanical alignment

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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