Risk Factor Involved in Knee Osteoarthritis (KOA)

Study of Anatomical and Imaging Characteristics in Relation With the Risk Factors Involved in KOA Progression

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: 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; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Other: The influence of ROS from the synovial fluid on the severity of 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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients without knee osteoarthritis (KOA) grade 0; Patient without knee affection	Other: 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; 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.; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.; Other: The influence of ROS from the synovial fluid on the severity of KOA; Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.
Experimental: Patients with KOA grade I; Kellgren-Lawrence classification (KL) grade I- doubtful narrowing of the joint space and possible osteophytes	Other: 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; 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.; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.; Other: The influence of ROS from the synovial fluid on the severity of KOA; Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.
Experimental: Patients with KOA grade II; KL grade II - definite osteophytes and possible narrowing of joint space.	Other: 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; 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.; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.; Other: The influence of ROS from the synovial fluid on the severity of KOA; Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.
Experimental: Patients with KOA grade III; KL grade III- definite narrowing of the joint space, significant osteophytosis, and possible bone deformities.	Other: 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; 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.; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.; Other: The influence of ROS from the synovial fluid on the severity of KOA; Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.
Experimental: Patients with KOA grade IV; KL grade IV- marked joint space narrowing accompanied by deformities, bone sclerosis, and large osteophytes	Other: 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; 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.; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.; Other: The influence of ROS from the synovial fluid on the severity of KOA; Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The influence of reactive oxygen species (ROS) level in KOA severity	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.	3 weeks

Collaborators and Investigators

• Sponsor: Iacob Czihac Emergency Military Clinical Hospital
• Investigators: Principal Investigator: Nicoleta B Tudorachi, MD, "Ovidius" University of Constanța, Romania

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: February 18, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 10/A575

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
• product manufactured in and exported from the U.S.: No