Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

Study 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).

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

Conditions
-----------------
Bilateral Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Total knee arthroplasty


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Staged total knee arthroplasty<br>Staged replacement of both knees in two separate surgeries. | Procedure: Total knee arthroplasty<br>* Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty<br>|
| Experimental: Simultaneous total knee arthroplasty<br>Simultaneous replacement of both knees in a single surgery. | Procedure: Total knee arthroplasty<br>* Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smart-phone based 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 | Change from preoperative gait analysis at 3rd month gait analysis | 
| smart-phone based 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 | Change from 3rd month gait analysis at 6th month gait analysis | 
| smart-phone based 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 | Change from 6th month gait analysis at 12th month gait analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee functional scores | 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 | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smart-phone, Bilateral knee arthroplasty, Gait analysis