Risk Factor Involved in Knee Osteoarthritis (KOA)

NCT05749601 | Completed

• 1 other identifier: 10/A575
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The influence of patellofemoral morphology in KOA severity

  1 week

Other Outcomes (1)

• The influence of reactive oxygen species (ROS) level in KOA severity

  3 weeks

Study Arms (5)

Patients without knee osteoarthritis (KOA) grade 0

ACTIVE COMPARATOR

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; 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

Patients with KOA grade I

EXPERIMENTAL

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; 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

Patients with KOA grade II

EXPERIMENTAL

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; 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

Patients with KOA grade III

EXPERIMENTAL

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; 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

Patients with KOA grade IV

EXPERIMENTAL

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; 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

Interventions

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

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.

Patients with KOA grade I; Patients with KOA grade II; Patients with KOA grade III; Patients with KOA grade IV; Patients without knee osteoarthritis (KOA) grade 0

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

Patients with KOA grade I; Patients with KOA grade II; Patients with KOA grade III; Patients with KOA grade IV; Patients without knee osteoarthritis (KOA) grade 0

The influence of ROS from the synovial fluid on the severity of KOA 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; Patients with KOA grade II; Patients with KOA grade III; Patients with KOA grade IV; Patients without knee osteoarthritis (KOA) grade 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iacob Czihac Emergency Military Clinical Hospital: lead

Study Sites (1)

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

Iași, Romania

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

ETV3 protein, human; Reactive Nitrogen Species

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Free Radicals; Inorganic Chemicals; Nitrogen Compounds; Organic Chemicals; Nitroso Compounds

Study Officials

• Nicoleta B Tudorachi, MD

  "Ovidius" University of Constanța, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: March 1, 2023
• Study Start: March 1, 2022
• Primary Completion: June 16, 2022
• Study Completion: August 19, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)