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Risk Factor Involved in Knee Osteoarthritis (KOA)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid
The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis
The influence of ROS from the synovial fluid on the severity of KOA
Sponsored by
Iacob Czihac Emergency Military Clinical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: male and female with knee pain (complaints); presented symptoms and clinical signs corresponding to KOA and had knee X-rays in the anteroposterior view and nuclear magnetic resonance (NMR) performed for setting the diagnosis with unilateral or bilateral knee pain; patients with clinically determined and recorded values of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and the glycemia in the clinical observation sheet. Exclusion Criteria: patients presenting lower limb arthroplasties; history of lower limb or pelvis fractures and previous knee surgery: ligamentoplasty, meniscectomy; inflammatory rheumatic diseases such as rheumatoid polyarthritis; other major conditions like malignant illness.

Sites / Locations

  • 3 "Iacob Czihac" Emergency Military Clinical Hospital, 7-9 General Henri Mathias Berthelot St., 700483 Iasi, Romania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Patients without knee osteoarthritis (KOA) grade 0

Patients with KOA grade I

Patients with KOA grade II

Patients with KOA grade III

Patients with KOA grade IV

Arm Description

Patient without knee affection

Kellgren-Lawrence classification (KL) grade I- doubtful narrowing of the joint space and possible osteophytes

KL grade II - definite osteophytes and possible narrowing of joint space.

KL grade III- definite narrowing of the joint space, significant osteophytosis, and possible bone deformities.

KL grade IV- marked joint space narrowing accompanied by deformities, bone sclerosis, and large osteophytes

Outcomes

Primary Outcome Measures

The influence of metabolic syndrome parametres and environment of origin in KOA severity
In this part of the study I included 85 patients for whom I measure the parameters of the metabolic syndrome: a high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglyceride, total cholesterol and body mass index (BMI) and I made the corelation of knee osteoarthritis (KOA) Kellgren-Lawrence radiological classification (KL). The formula form BMI was kg/ m2. I raported the influence of the environment of origin in relation to the severity of KOA, performing the statistical analysis of the obtained data, applied metod ANOVA, specific ordinal and binomial logistic regression models, p value <0,005. 95% confidence interval, without non-inferiority/equivalence test.

Secondary Outcome Measures

The influence of patellofemoral morphology in KOA severity
I measured distal femoral torsion angle, patellofemoral congruence angle and sulcus angle for 43 patients who had NRM examinations and I raported their impact in KOA severity under the influence of sex and age.

Full Information

First Posted
October 19, 2022
Last Updated
March 1, 2023
Sponsor
Iacob Czihac Emergency Military Clinical Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05749601
Brief Title
Risk Factor Involved in Knee Osteoarthritis (KOA)
Official Title
Study of Anatomical and Imaging Characteristics in Relation With the Risk Factors Involved in KOA Progression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
August 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iacob Czihac Emergency Military Clinical Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical study regarding the incidence and severity of knee osteoarthritis (KOA) in a certain area from South-Eastern Europe. Aim of the clinical study: to determine the KOA grade through X-Ray studies, to perform nuclear magnetic resonance (NMR) analysis to assess the KOA severity and to determine the level of significant parameters in the synovial liquid extracted from the patients presenting KOA.
Detailed Description
Clinical study regarding the incidence and severity of KOA in a certain area from South-Eastern Europe. Clinical study on 85 patients out 373 participants that were screened, chosen based on inclusion/exclusion criteria. Aim of the clinical study: to determine the KOA grade through X-Ray studies, to perform nuclear magnetic resonance (NRM) analysis to assess the KOA severity. Data corroboration of the KOA degree with the results of the blood samples analysis, looking for the influence of the metabolic syndrome (MetS) parameters - high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, glycemia, and then the body mass index (BMI). In the meantime, there is intended to associate the environment of origin of the patients from the trial group with the KOA incidence and severity. To determine the level of significant parameters in the synovial liquid extracted from the patients presenting KOA, analysis of the degradation products present in the synovial fluid of patients with KOA, such as free radicals, like reactive oxygen species (ROS) and reactive nitrogen species (RNS) and their influence on the severity of the pathology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients without knee osteoarthritis (KOA) grade 0
Arm Type
Active Comparator
Arm Description
Patient without knee affection
Arm Title
Patients with KOA grade I
Arm Type
Experimental
Arm Description
Kellgren-Lawrence classification (KL) grade I- doubtful narrowing of the joint space and possible osteophytes
Arm Title
Patients with KOA grade II
Arm Type
Experimental
Arm Description
KL grade II - definite osteophytes and possible narrowing of joint space.
Arm Title
Patients with KOA grade III
Arm Type
Experimental
Arm Description
KL grade III- definite narrowing of the joint space, significant osteophytosis, and possible bone deformities.
Arm Title
Patients with KOA grade IV
Arm Type
Experimental
Arm Description
KL grade IV- marked joint space narrowing accompanied by deformities, bone sclerosis, and large osteophytes
Intervention Type
Other
Intervention Name(s)
Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid
Intervention Description
Highlighting the influence of environment of origin on KOA incidence and corelated impact of high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides and body mass index (BMI). The analytes from synovial fluid were determined by fluorometric method.
Intervention Type
Other
Intervention Name(s)
The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis
Intervention Description
Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.
Intervention Type
Other
Intervention Name(s)
The influence of ROS from the synovial fluid on the severity of KOA
Intervention Description
Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.
Primary Outcome Measure Information:
Title
The influence of metabolic syndrome parametres and environment of origin in KOA severity
Description
In this part of the study I included 85 patients for whom I measure the parameters of the metabolic syndrome: a high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglyceride, total cholesterol and body mass index (BMI) and I made the corelation of knee osteoarthritis (KOA) Kellgren-Lawrence radiological classification (KL). The formula form BMI was kg/ m2. I raported the influence of the environment of origin in relation to the severity of KOA, performing the statistical analysis of the obtained data, applied metod ANOVA, specific ordinal and binomial logistic regression models, p value <0,005. 95% confidence interval, without non-inferiority/equivalence test.
Time Frame
up 2 weeks
Secondary Outcome Measure Information:
Title
The influence of patellofemoral morphology in KOA severity
Description
I measured distal femoral torsion angle, patellofemoral congruence angle and sulcus angle for 43 patients who had NRM examinations and I raported their impact in KOA severity under the influence of sex and age.
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
The influence of reactive oxygen species (ROS) level in KOA severity
Description
In this analysis, 28 patients were included and I studied the average of 3 determinations of ROS from the synovial fluid using the OxiSelectTM kit and their impact in KOA severity under the influence of some biochemicals blood constants.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: male and female with knee pain (complaints); presented symptoms and clinical signs corresponding to KOA and had knee X-rays in the anteroposterior view and nuclear magnetic resonance (NMR) performed for setting the diagnosis with unilateral or bilateral knee pain; patients with clinically determined and recorded values of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and the glycemia in the clinical observation sheet. Exclusion Criteria: patients presenting lower limb arthroplasties; history of lower limb or pelvis fractures and previous knee surgery: ligamentoplasty, meniscectomy; inflammatory rheumatic diseases such as rheumatoid polyarthritis; other major conditions like malignant illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicoleta B Tudorachi, MD
Organizational Affiliation
"Ovidius" University of Constanța, Romania
Official's Role
Principal Investigator
Facility Information:
Facility Name
3 "Iacob Czihac" Emergency Military Clinical Hospital, 7-9 General Henri Mathias Berthelot St., 700483 Iasi, Romania
City
Iaşi
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No

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Risk Factor Involved in Knee Osteoarthritis (KOA)

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