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Clinical Trials/NCT04975165
NCT04975165
Unknown
Not Applicable

Comparison of Smart-phone Based Gait Analysis Between Simultaneous and Staged Total Knee Arthroplasties

Gulhane Training and Research Hospital1 site in 1 country84 target enrollmentMay 26, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bilateral Knee Osteoarthritis
Sponsor
Gulhane Training and Research Hospital
Enrollment
84
Locations
1
Primary Endpoint
smart-phone based gait analysis
Last Updated
4 years ago

Overview

Brief Summary

Total knee arthroplasty is a well-known treatment of the end-stage osteoarthritis of the knee. In the case of bilateral end-stage knee osteoarthritis, both of the knees need total knee arthroplasty. Bilateral total knee arthroplasty could be performed simultaneously or staged according to the preference of the patients. Simultaneous total knee arthroplasty is defined as the replacement of both knees in a single surgery. The major advantage of simultaneous total knee arthroplasty this surgery is that it requires only one hospital stay and a rehabilitation period to recover both knees, but higher blood transfusion rates and thromboembolism risk are still major concerns. Therefore, in this comparative study, smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing simultaneous and staged total knee arthroplasty, at 3, 6, and 12 months postoperatively

Detailed Description

Patients with bilateral end-stage knee osteoarthritis will be included in the current study. Bilateral total knee arthroplasty will be performed simultaneously or staged according to the preference of the patients. We will have two groups: staged total knee arthroplasty and simultaneous total knee arthroplasty groups. The patients will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (Knee Society Scores and Knee Injury and Osteoarthritis Outcome Score), 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).

Registry
clinicaltrials.gov
Start Date
May 26, 2021
End Date
January 31, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gulhane Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Deniz CANKAYA

Assoc. Professor

Gulhane Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of bilateral 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 Unilateral knee osteoarthritis Insufficiency of knee collateral ligaments.

Outcomes

Primary Outcomes

smart-phone based gait analysis

Time Frame: Change from 6th month gait analysis at 12th month gait analysis

Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application

Secondary Outcomes

  • Knee functional scores(Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS))

Study Sites (1)

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