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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
total knee arthroplasty
Sponsored by
Gulhane Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee arthroplasty, gait analysis, smart-phone

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gulhane Teaching and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Posterior-cruciate-ligament-retaining (CR)

posterior-cruciate-ligament-stabilized (PS)

Arm Description

Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty

Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty

Outcomes

Primary Outcome Measures

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
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
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

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

First Posted
July 5, 2021
Last Updated
July 8, 2021
Sponsor
Gulhane Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04968600
Brief Title
Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Arthroplasties
Official Title
Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Total Knee Arthroplasties: Gait Analysis With a Smartphone Application
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 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
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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee arthroplasty, gait analysis, smart-phone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Posterior-cruciate-ligament-retaining (CR)
Arm Type
Experimental
Arm Description
Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty
Arm Title
posterior-cruciate-ligament-stabilized (PS)
Arm Type
Experimental
Arm Description
Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
total knee arthroplasty
Intervention Description
Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty
Primary Outcome Measure Information:
Title
smart-phone based gait analysis
Description
Gait analysis 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 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 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 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.
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
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
First Name & Middle Initial & Last Name & Degree
Denizhan SIVRI, MD
Organizational Affiliation
Gulhane Teaching and Research Hospital
Official's Role
Principal Investigator
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
+905426688056
Email
cankayadeniz78@gmail.com
First Name & Middle Initial & Last Name & Degree
Denizhan SIVRI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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