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This is a prospective, observational cohort study involving 40 patients with primary knee osteoarthritis hospitalized in a rehabilitation hospital in Cluj-Napoca. All participants will receive intra-articular platelet-rich plasma (PRP) injections. The study aims to analyze PRP composition and inflammatory biomarkers to better understand disease mechanisms and evaluate treatment effectiveness.
The study is designed as an observational, longitudinal, prospective cohort investigation focused on patients with primary degenerative pathology of the knee joint, specifically primary gonarthrosis. The target population includes individuals diagnosed with knee osteoarthritis, while the accessible population consists of patients admitted to the Clinical Rehabilitation Hospital in Cluj-Napoca.
A total of 40 consecutive patients meeting inclusion criteria will be enrolled. Each participant will undergo treatment consisting of an intra-articular injection of platelet-rich plasma (PRP) at the knee level. The consecutive inclusion approach reduces selection bias and reflects routine clinical practice.
A central component of the study is the biological characterization of PRP. The investigators will analyze its composition, particularly focusing on growth factors such as platelet-derived growth factor (PDGF), transforming growth factor beta 1 (TGF-β1), and insulin-like growth factor 1 (IGF-1). This analysis is intended to contribute to the standardization of PRP therapy in knee osteoarthritis.
In parallel, the study will assess systemic inflammatory status by measuring circulating biomarkers, including interleukins (IL-1β, IL-8, IL-18) and tumor necrosis factor alpha (TNF-α). Monitoring these biomarkers allows evaluation of the inflammatory response and provides insight into the biological effects of PRP on the intra-articular environment.
Overall, the study seeks to clarify both the pathophysiological mechanisms underlying knee osteoarthritis and the therapeutic mechanisms of PRP, while also assessing its clinical effectiveness through changes in inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets | Other | intra-articular administration of plasma rich in platelets (PRP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-articular administration of plasma rich in platelets (PRP) | Procedure | intraarticular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity assessed using the Visual Analogue Scale (VAS) | Baseline and at 4 weeks |
| Functional status and symptom severity | Functional status and symptom severity measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire Health-related quality of life evaluated with the SF-36 questionnaire | Basline and at 4 weeks |
| Systemic inflammatory markers | Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α | Baseline and at 4 weeks |
| General inflammatory indicators | General inflammatory indicators: erythrocyte sedimentation rate (ESR) | Baseline and at 4 weeks |
| General inflammatory indicators 2 | General inflammatory indicators: C-reactive protein (CRP) | Baseline and at 4 weeks |
| Growth factor profile of PRP | transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), insulin-like growth factor 1 (IGF-1), and vascular endothelial growth factor (VEGF) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| " Iuliu Hatieganu" University of medicine and Pharmacy | Cluj-Napoca | Cluj | 400347 | Romania |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D010976 | Platelet Count |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D010979 | Platelet Function Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |