Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

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

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

Study Overview

• Status: Recruiting
• Conditions: Bilateral Knee Osteoarthritis
• Intervention / Treatment: Procedure: Total knee arthroplasty

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 Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deniz Cankaya, Assoc.Prof.; Phone Number: +90 542 6688056; Email: cankayadeniz78@gmail.com
• Study Contact Backup: Name: Anıl Ozgur, MD; Phone Number: +90 554 3281193; Email: dr.anilozgur@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Recruiting
    • Gulhane Teaching and Research Hospital
    • Contact: Deniz Cankaya, Assoc.Prof.; Phone Number: +90 542 6688056; Email: cankayadeniz78@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Staged total knee arthroplasty; Staged replacement of both knees in two separate surgeries.	Procedure: Total knee arthroplasty; Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty
Experimental: Simultaneous total knee arthroplasty; Simultaneous replacement of both knees in a single surgery.	Procedure: Total knee arthroplasty; Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 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)

Collaborators and Investigators

• Sponsor: Gulhane Training and Research Hospital
• Investigators: Study Chair: Deniz CANKAYA, Assoc.Prof., Gulhane Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Gait analysis; Bilateral knee arthroplasty; Smart-phone
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2021/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No