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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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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.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior-cruciate-ligament-retaining (CR)<br>Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty | Procedure: total knee arthroplasty<br>* Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty<br>|
| Experimental: posterior-cruciate-ligament-stabilized (PS)<br>Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty | Procedure: total knee arthroplasty<br>* Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smart-phone based 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 | 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 | 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 | 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
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Keywords Provided by Centre Hospitalier Valida
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knee arthroplasty, gait analysis, smart-phone