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Total Knee Arthroplasty and Clinical Findings

Primary Purpose

Orthopedic Disorder, Arthropathy of Knee, Pain, Joint

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Total Knee Arthroplasty
Sponsored by
Karadeniz Technical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with grade 4 degeneration levels who had surgical indications between the ages of 45-75 were placed in the study group.
  • Patients without surgical indication, lower than 4 OA severity included in the control group

Exclusion Criteria:

  • Patients with surgical history of the ipsilateral side, neuropathic pain, loss of sensation, systemic, chronic and infectious disease were excluded from the study

Sites / Locations

  • Karadeniz Technical Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty

Twenty-two patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group.

Outcomes

Primary Outcome Measures

Proinflammatory cytokine level
Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.
Pain severity
The pain intensity were evaluated by the Visuel Analog Scale.
Functional status
The Western Ontario and McMaster Universities Arthritis Index was used for functional status.
Joint position sense
Electro-goniometer was used for proprioception evaluation
Valgity angle and amount of malaligment
In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist

Secondary Outcome Measures

Full Information

First Posted
July 17, 2020
Last Updated
July 23, 2020
Sponsor
Karadeniz Technical University
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1. Study Identification

Unique Protocol Identification Number
NCT04481711
Brief Title
Total Knee Arthroplasty and Clinical Findings
Official Title
Investigation of the Effect of Total Knee Arthroplasty on Proinflammatory Cytokine Level, Pain Severity, Functional Status, Joint Position Sense and Radiographic Findings
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
February 8, 2020 (Actual)
Study Completion Date
May 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity angle,malaligment, functional status and knee joint position sense.
Detailed Description
Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the TKA group (study group) and 22 patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group. Systemic venous blood samples of the patients were taken to evaluate the cytokine level (IL-6, TNF-α, IL-1). The Visual Analogue Scale was used to assess pain intensity, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score was used to evaluate the functional status. Valgity and malaligment measurements were calculated using antero-posterior X ray Digital goniometer was used to evaluate the knee joint position sense (at 35, 55 and 70 degrees knee flexion angles). Measurements were taken once from patients in the control group, and twice in pre-op and post-op sixth weeks from study group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Arthropathy of Knee, Pain, Joint, Proprioception, Radiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Twenty-two patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group.
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty
Intervention Description
Osteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA.
Primary Outcome Measure Information:
Title
Proinflammatory cytokine level
Description
Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.
Time Frame
30 minutes
Title
Pain severity
Description
The pain intensity were evaluated by the Visuel Analog Scale.
Time Frame
15 minutes
Title
Functional status
Description
The Western Ontario and McMaster Universities Arthritis Index was used for functional status.
Time Frame
30 minutes
Title
Joint position sense
Description
Electro-goniometer was used for proprioception evaluation
Time Frame
30 minutes
Title
Valgity angle and amount of malaligment
Description
In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with grade 4 degeneration levels who had surgical indications between the ages of 45-75 were placed in the study group. Patients without surgical indication, lower than 4 OA severity included in the control group Exclusion Criteria: Patients with surgical history of the ipsilateral side, neuropathic pain, loss of sensation, systemic, chronic and infectious disease were excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Emirzeoğlu
Organizational Affiliation
Karadeniz Technical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arzu Erden
Organizational Affiliation
Karadeniz Technical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kübra Canlı
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Serap Özer Yaman
Organizational Affiliation
Karadeniz Technical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
İbrahim Pekşen
Organizational Affiliation
Karadeniz Technical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Osman Aynacı
Organizational Affiliation
Karadeniz Technical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Süleyman Caner Karahan
Organizational Affiliation
Karadeniz Technical University
Official's Role
Study Chair
Facility Information:
Facility Name
Karadeniz Technical Üniversitesi
City
Trabzon
State/Province
Türkiye
ZIP/Postal Code
61080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Total Knee Arthroplasty and Clinical Findings

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