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

March 14, 2024 updated by: Yot Tanariyakul, Thammasat University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathum Thani
      • Khlong Luang, Pathum Thani, Thailand, 12120
        • Recruiting
        • Thammasat University
        • Principal Investigator:
          • Nattapol Tammachote, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Restricted kinematic alignment
Procedure: Restricted kinematic alignment
TKA using restricted kinematic alignment under robotic assisted surgery (MAKO).
Active Comparator: Mechanical alignment
Procedure: Mechanical alignment
TKA using mechanical alignment under robotic assisted surgery (MAKO).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forgotten joint score
Time Frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Point 0-100 (0 mean worst, 100 mean best)
6 weeks, 3months, 6 months, 1 year and 2 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified WOMAC score
Time Frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Point 0-96 (0 mean best, 100 mean worst)
6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Range of motion
Time Frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Using long arm goniometer (degrees)
6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Pain score
Time Frame: 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)
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
Hip knee ankle angle
Time Frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Evaluate by long radiograph (degrees)
6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Complications
Time Frame: Until 2 years after surgery
For example periprosthetic fracture, infection or aspetic loosening
Until 2 years after surgery
Incidence of soft tissue releasing
Time Frame: During surgery
Record soft tissue releasing intraoperative
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 14, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUH rKA vs MA TKA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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