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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968600
• Other study ID #: 2021/15
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: July 2021
• Source: Gulhane Training and Research Hospital
• Contact: Deniz CANKAYA, Assoc.Prof.
• Phone: +90 542 6688056
• Email: cankayadeniz78[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• total knee arthroplasty
Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty

Locations

Country	Name	City	State
Turkey	Gulhane Teaching and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)