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Risk Factor Involved in Knee Osteoarthritis (KOA)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05749601
Enrollment
85
Registered
2023-03-01
Start date
2022-03-01
Completion date
2022-08-19
Last updated
2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

OTHERInfluence 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.

OTHERThe 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.

OTHERThe 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.

Sponsors

Iacob Czihac Emergency Military Clinical Hospital
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The influence of metabolic syndrome parametres and environment of origin in KOA severityup 2 weeksIn 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

MeasureTime frameDescription
The influence of patellofemoral morphology in KOA severity1 weekI 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.

Other

MeasureTime frameDescription
The influence of reactive oxygen species (ROS) level in KOA severity3 weeksIn 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.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026