Risk Factor Involved in Knee Osteoarthritis (KOA)

Iacob Czihac Emergency Military Clinical Hospital

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: 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 ROS from the synovial fluid on the severity of KOA; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05749601

10/A575

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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85 participants in 5 patient groups

Patients without knee osteoarthritis (KOA) grade 0

Active Comparator group

Description:

Patient without knee affection

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 ROS from the synovial fluid on the severity of KOA

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

Patients with KOA grade I

Experimental group

Description:

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

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 ROS from the synovial fluid on the severity of KOA

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

Patients with KOA grade II

Experimental group

Description:

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

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 ROS from the synovial fluid on the severity of KOA

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

Patients with KOA grade III

Experimental group

Description:

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

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 ROS from the synovial fluid on the severity of KOA

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

Patients with KOA grade IV

Experimental group

Description:

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

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 ROS from the synovial fluid on the severity of KOA

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