Platelet-Rich Plasma Composition and Clinical Effects in Knee Osteoarthritis
Study of the Composition of Platelet-rich Plasma and Its Clinical and Molecular Effect in the Biological Treatment of Knee Arthrosis
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Cluj
-
Cluj-Napoca、Cluj、ルーマニア、400347
- " Iuliu Hatieganu" University of medicine and Pharmacy
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age between 40 and 80 years
- Diagnosis of unilateral or bilateral gonarthrosis radiological grade 2-3 Kellgren-Lawrence
- Knee joint pain greater than 4 on the VAS scale
- History of knee joint pain for at least 6 months
- Patients who are to receive an inpatient PRP injection
Exclusion Criteria:
- Diagnosis of secondary gonarthrosis
- History of inflammatory rheumatological disease or gout
- History of recent minor (1 month) or major (2 years) trauma to the knee joint
- History of knee surgery or arthroscopy
- Infiltrations, physiotherapy or other knee treatments in the last 3 months
- Diagnosis of neoplasia, hematological or immunological diseases
- Clinical or biological signs of acute infection
- Coagulation disorders
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets
intra-articular administration of plasma rich in platelets (PRP)
|
intraarticular injection
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensity
時間枠：Baseline and at 4 weeks
|
Pain intensity assessed using the Visual Analogue Scale (VAS)
|
Baseline and at 4 weeks
|
|
Functional status and symptom severity
時間枠：Basline and at 4 weeks
|
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
時間枠：Baseline and at 4 weeks
|
Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α
|
Baseline and at 4 weeks
|
|
General inflammatory indicators
時間枠：Baseline and at 4 weeks
|
General inflammatory indicators: erythrocyte sedimentation rate (ESR)
|
Baseline and at 4 weeks
|
|
General inflammatory indicators 2
時間枠：Baseline and at 4 weeks
|
General inflammatory indicators: C-reactive protein (CRP)
|
Baseline and at 4 weeks
|
|
Growth factor profile of PRP
時間枠：Baseline
|
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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。