Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

Not Applicable

• Conditions: Bilateral Knee Osteoarthritis
• Interventions: Procedure: Total knee arthroplasty

• Registration Number: NCT04975165
• Lead Sponsor: Gulhane Training and Research Hospital

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).

Study Timeline

• Study Start: 2021-05-26
• Status Verified: 2021-07
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-22
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-29
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simultaneous total knee arthroplasty	Total knee arthroplasty	Simultaneous replacement of both knees in a single surgery.
Staged total knee arthroplasty	Total knee arthroplasty	Staged replacement of both knees in two separate surgeries.

Primary Outcome Measures

Name	Time	Method
smart-phone based gait analysis	Change from 6th month gait analysis at 12th month 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

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