Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

Bilateral Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04975165
• Other study ID #: 2021/16
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 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

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• 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 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.

Related Conditions & MeSH terms

• Bilateral Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Total knee arthroplasty
Bilateral surgery in one arm and staged surgery 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 (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
Primary	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
Primary	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	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)