Three Dimensional Gait Analysis After Total Knee Arthroplasty - Comparison of Objective and Patient-reported Outcomes Between Rotational and Fixed Tibial Platforms.

March 31, 2026 updated by: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

3D Gait Analysis After Total Knee Arthroplasty: Rotational vs Fixed Tibial Platforms

We prospectively enrolled patients with knee osteoarthritis indicated for total knee arthroplasty and randomized for either mobile rotational tibial platform arthroplasty or fixed-stabilised tibial platform arthroplasty. We regularly performed 3D Gait Analysis (preoperatively and in several postoperative periods) to see if either of the implants results in better objective and patient-reported outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Czechia
    • Ústecký kraj
      • Ústí nad Labem, Ústecký kraj, Czechia, 40001
        • Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem

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

Yes

Description

Inclusion Criteria:

  • high-stage of knee osteoarthritis

Exclusion Criteria:

  • none

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rotational tibial platform total knee arthroplasty
Procedure: total knee arthroplasty
Standard anteromedial approach total knee arthroplasty with cemented components.
Active Comparator: Fixed tibial platform total knee arthroplasty
Procedure: total knee arthroplasty
Standard anteromedial approach total knee arthroplasty with cemented components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gait Profile Score
Time Frame: from preoperative to 1 year postoperative
from preoperative to 1 year postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified Harris Hip Score
Time Frame: from preoperative to 1 year postoperative
from preoperative to 1 year postoperative

Collaborators and Investigators

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

Sponsor

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

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 (Actual)

January 20, 2022

Primary Completion (Actual)

January 20, 2024

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3DGAKNEE

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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