Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2023-01-31

Brief Summary

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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

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Detailed Description

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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

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Bilateral Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Staged total knee arthroplasty

Staged replacement of both knees in two separate surgeries.

Group Type EXPERIMENTAL

Total knee arthroplasty

Intervention Type PROCEDURE

Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty

Simultaneous total knee arthroplasty

Simultaneous replacement of both knees in a single surgery.

Group Type EXPERIMENTAL

Total knee arthroplasty

Intervention Type PROCEDURE

Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty

Interventions

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Total knee arthroplasty

Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No