Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Arthroplasties

July 8, 2021 updated by: Deniz CANKAYA, Gulhane Training and Research Hospital

Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Total Knee Arthroplasties: Gait Analysis With a Smartphone Application

In total knee arthroplasty (TKA), the posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) techniques are widely used depending on the individual preference of the surgeon. Comparative analysis of these two techniques is a major topic of investigation in arthroplasty research. The hypothesis of the present study is that compared with the CR technique, the PS technique is associated with a worse gait pattern. Smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing total knee arthroplasty with a CR and a PS technique, at 3, 6, and 12 months postoperatively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing total knee arthroplasty are randomized to posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) groups by generating random numbers with Microsoft Excel. The patients are/will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (KSS and KOOS), life quality (SF-12), and smart-phone based gait analysis. All data will be calculated as mean and standard deviation values. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).

Study Type

Interventional

Enrollment (Anticipated)

86

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 Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Recruiting
        • Gulhane Teaching and Research Hospital
        • Contact:
        • Principal Investigator:
          • Denizhan SIVRI, MD

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of unilateral primary knee osteoarthritis
  • Age 55 to 85 years
  • Must be able to walk without support

Exclusion Criteria:

  • Rheumatological joint diseases
  • Previous knee surgery
  • Neuromuscular diseases
  • Bilateral knee osteoarthritis
  • Insufficiency of knee collateral ligaments.

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
Experimental: Posterior-cruciate-ligament-retaining (CR)
Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty
Procedure: total knee arthroplasty
Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty
Experimental: posterior-cruciate-ligament-stabilized (PS)
Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty
Procedure: total knee arthroplasty
Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smart-phone based gait analysis
Time Frame: Change from preoperative gait analysis at 3rd month gait analysis
Gait analysis is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
Change from preoperative gait analysis at 3rd month gait analysis
smart-phone based gait analysis
Time Frame: Change from 3rd month gait analysis at 6th month gait analysis
Gait analysis is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
Change from 3rd month gait analysis at 6th month gait analysis
smart-phone based gait analysis
Time Frame: Change from 6th month gait analysis at 12th month gait analysis
Gait analysis is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
Change from 6th month gait analysis at 12th month gait analysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee functional scores
Time Frame: Change from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Change from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)
Knee functional scores
Time Frame: Change from 3rd month Knee Society Scores (KSS) at 6th month Knee Society Score (KSS)
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Change from 3rd month Knee Society Scores (KSS) at 6th month Knee Society Score (KSS)
Knee functional scores
Time Frame: Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)

Collaborators and Investigators

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

Sponsor

Gulhane Training and Research Hospital

Investigators

  • Study Chair: Deniz CANKAYA, Assoc.Prof., Gulhane Teaching and Research Hospital
  • Principal Investigator: Denizhan SIVRI, MD, Gulhane Teaching and Research Hospital

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)

April 28, 2021

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/15

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.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on total knee arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe