Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties
Primary Purpose
Bilateral Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Total knee arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Knee Osteoarthritis focused on measuring Bilateral knee arthroplasty, Gait analysis, Smart-phone
Eligibility Criteria
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.
Sites / Locations
- Gulhane Teaching and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Staged total knee arthroplasty
Simultaneous total knee arthroplasty
Arm Description
Staged replacement of both knees in two separate surgeries.
Simultaneous replacement of both knees in a single surgery.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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 )
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 )
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 )
Full Information
NCT ID
NCT04975165
First Posted
July 21, 2021
Last Updated
July 22, 2021
Sponsor
Gulhane Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04975165
Brief Title
Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties
Official Title
Comparison of Smart-phone Based Gait Analysis Between Simultaneous and Staged Total Knee Arthroplasties
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Knee Osteoarthritis
Keywords
Bilateral knee arthroplasty, Gait analysis, Smart-phone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Staged total knee arthroplasty
Arm Type
Experimental
Arm Description
Staged replacement of both knees in two separate surgeries.
Arm Title
Simultaneous total knee arthroplasty
Arm Type
Experimental
Arm Description
Simultaneous replacement of both knees in a single surgery.
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty
Primary Outcome Measure Information:
Title
smart-phone based gait analysis
Description
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
Time Frame
Change from preoperative gait analysis at 3rd month gait analysis
Title
smart-phone based gait analysis
Description
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
Time Frame
Change from 3rd month gait analysis at 6th month gait analysis
Title
smart-phone based gait analysis
Description
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
Time Frame
Change from 6th month gait analysis at 12th month gait analysis
Secondary Outcome Measure Information:
Title
Knee functional scores
Description
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Time Frame
Change from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)
Title
Knee functional scores
Description
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Time Frame
Change from 3rd month Knee Society Scores (KSS) at 6th month Knee Society Score (KSS)
Title
Knee functional scores
Description
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Time Frame
Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz Cankaya, Assoc.Prof.
Phone
+90 542 6688056
Email
cankayadeniz78@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anıl Ozgur, MD
Phone
+90 554 3281193
Email
dr.anilozgur@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz CANKAYA, Assoc.Prof.
Organizational Affiliation
Gulhane Teaching and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Gulhane Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniz Cankaya, Assoc.Prof.
Phone
+90 542 6688056
Email
cankayadeniz78@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties
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