Risk Factor Involved in Knee Osteoarthritis (KOA)

NCT ID: NCT05749601

Last Updated: 2023-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-08-19

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients without knee osteoarthritis (KOA) grade 0

Patient without knee affection

Group Type ACTIVE_COMPARATOR

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 Type OTHER

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.

The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis

Intervention Type OTHER

Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.

The influence of ROS from the synovial fluid on the severity of KOA

Intervention Type OTHER

Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.

Patients with KOA grade I

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

Group Type EXPERIMENTAL

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 Type OTHER

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.

The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis

Intervention Type OTHER

Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.

The influence of ROS from the synovial fluid on the severity of KOA

Intervention Type OTHER

Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.

Patients with KOA grade II

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

Group Type EXPERIMENTAL

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 Type OTHER

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.

The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis

Intervention Type OTHER

Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.

The influence of ROS from the synovial fluid on the severity of KOA

Intervention Type OTHER

Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.

Patients with KOA grade III

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

Group Type EXPERIMENTAL

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 Type OTHER

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.

The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis

Intervention Type OTHER

Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.

The influence of ROS from the synovial fluid on the severity of KOA

Intervention Type OTHER

Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.

Patients with KOA grade IV

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

Group Type EXPERIMENTAL

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 Type OTHER

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.

The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis

Intervention Type OTHER

Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.

The influence of ROS from the synovial fluid on the severity of KOA

Intervention Type OTHER

Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iacob Czihac Emergency Military Clinical Hospital

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicoleta B Tudorachi, MD

Role: PRINCIPAL_INVESTIGATOR

"Ovidius" University of Constanța, Romania

Locations

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

Iași, , Romania

Site Status

Countries

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Romania

Other Identifiers

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10/A575

Identifier Type: -

Identifier Source: org_study_id

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