Clinical Trials Directory

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UnknownNCT04975165

Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
84 (estimated)
Sponsor
Gulhane Training and Research Hospital · Other Government
Sex
All
Age
55 Years – 85 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDURETotal knee arthroplastyBilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty

Timeline

Start date
2021-05-26
Primary completion
2023-01-31
Completion
2023-01-31
First posted
2021-07-23
Last updated
2021-07-29

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04975165. Inclusion in this directory is not an endorsement.