Risk Factor Involved in Knee Osteoarthritis (KOA)
- Conditions
- Knee Osteoarthritis
- Interventions
- 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 fluidOther: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritisOther: The influence of ROS from the synovial fluid on the severity of KOA
- Registration Number
- NCT05749601
- Lead Sponsor
- Iacob Czihac Emergency Military Clinical Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Patients with KOA grade I The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis Kellgren-Lawrence classification (KL) grade I- doubtful narrowing of the joint space and possible osteophytes Patients with KOA grade I 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 Kellgren-Lawrence classification (KL) grade I- doubtful narrowing of the joint space and possible osteophytes Patients without knee osteoarthritis (KOA) grade 0 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 Patient without knee affection Patients without knee osteoarthritis (KOA) grade 0 The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis Patient without knee affection Patients without knee osteoarthritis (KOA) grade 0 The influence of ROS from the synovial fluid on the severity of KOA Patient without knee affection Patients with KOA grade I The influence of ROS from the synovial fluid on the severity of KOA Kellgren-Lawrence classification (KL) grade I- doubtful narrowing of the joint space and possible osteophytes Patients with KOA grade II The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis KL grade II - definite osteophytes and possible narrowing of joint space. Patients with KOA grade III 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 KL grade III- definite narrowing of the joint space, significant osteophytosis, and possible bone deformities. Patients with KOA grade IV The influence of ROS from the synovial fluid on the severity of KOA KL grade IV- marked joint space narrowing accompanied by deformities, bone sclerosis, and large osteophytes Patients with KOA grade II 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 KL grade II - definite osteophytes and possible narrowing of joint space. Patients with KOA grade IV The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis KL grade IV- marked joint space narrowing accompanied by deformities, bone sclerosis, and large osteophytes Patients with KOA grade II The influence of ROS from the synovial fluid on the severity of KOA KL grade II - definite osteophytes and possible narrowing of joint space. Patients with KOA grade IV 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 KL grade IV- marked joint space narrowing accompanied by deformities, bone sclerosis, and large osteophytes Patients with KOA grade III The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis KL grade III- definite narrowing of the joint space, significant osteophytosis, and possible bone deformities. Patients with KOA grade III The influence of ROS from the synovial fluid on the severity of KOA KL grade III- definite narrowing of the joint space, significant osteophytosis, and possible bone deformities.
- Primary Outcome Measures
Name Time Method The influence of metabolic syndrome parametres and environment of origin in KOA severity up 2 weeks 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.
- Secondary Outcome Measures
Name Time Method The influence of patellofemoral morphology in KOA severity 1 week 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.
Trial Locations
- Locations (1)
3 "Iacob Czihac" Emergency Military Clinical Hospital, 7-9 General Henri Mathias Berthelot St., 700483 Iasi, Romania
🇷🇴Iaşi, Romania