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

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: total knee arthroplasty

• Registration Number: NCT04968600
• Lead Sponsor: Gulhane Training and Research Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-04-28
• Status Verified: 2021-07
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
posterior-cruciate-ligament-stabilized (PS)	total knee arthroplasty	Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty
Posterior-cruciate-ligament-retaining (CR)	total knee arthroplasty	Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty

Primary Outcome Measures

Name	Time	Method
smart-phone based gait analysis	Change from 6th month gait analysis at 12th month gait analysis	Gait analysis is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application

Secondary Outcome Measures

Name	Time	Method
Knee functional scores	Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)	Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )

Trial Locations

Locations (1)

Gulhane Teaching and Research Hospital; 🇹🇷 Ankara, Turkey