膝関節症におけるヒアルロン酸関節内投与とフィブリノゲンの併用の有効性と安全性
膝関節症患者におけるヒアルロン酸関節内投与とフィブリノゲンの併用の有効性と安全性の評価
This study aims to evaluate the effectiveness and safety of intra-articular injections of hyaluronic acid conjugated with fibrinogen in patients with knee osteoarthritis.
Knee osteoarthritis is a common degenerative joint disease that causes pain, stiffness, and reduced mobility, significantly affecting quality of life. Hyaluronic acid injections are widely used to relieve symptoms, but their effectiveness may be limited in some patients. Fibrinogen has potential biological effects that may enhance tissue repair and anti-inflammatory responses.
In this single-arm clinical study, patients with knee osteoarthritis will receive intra-articular injections of hyaluronic acid conjugated with fibrinogen. Clinical outcomes, including pain relief, functional improvement, and adverse events, will be assessed during follow-up visits.
The results of this study may provide additional evidence regarding the potential benefits and safety of conjugating hyaluronic acid with fibrinogen for the treatment of knee osteoarthritis.
調査の概要
詳細な説明
This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of intra-articular hyaluronic acid conjugated with fibrinogen in patients with knee osteoarthritis.
Eligible patients diagnosed with knee osteoarthritis according to clinical and radiographic criteria will be enrolled. All participants will receive intra-articular injections of hyaluronic acid conjugated with fibrinogen administered under sterile conditions.
The primary objectives of the study are to assess changes in pain intensity and knee function following treatment. Secondary objectives include evaluation of functional outcomes, patient-reported quality of life, and the occurrence of adverse events related to the intervention.
Patients will be followed for a predefined period after injection, during which clinical assessments will be performed at scheduled visits. Pain and functional outcomes will be evaluated using validated clinical scales. Safety assessments will include monitoring and recording of any local or systemic adverse events throughout the study period.
This study is conducted as part of a doctoral research project in clinical pharmacology at the University of Medicine and Pharmacy at Ho Chi Minh City. The study protocol has been reviewed and approved by the Institutional Review Board of the University of Medicine and Pharmacy at Ho Chi Minh City prior to initiation.
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
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-
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Ho Chi Minh City、ベトナム、700000
- Xuong Khop Viet clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female patients aged 45 to 75 years.
- Diagnosed with primary knee osteoarthritis according to the American College of Rheumatology (ACR) 1991 criteria.
- Vietnamese patients.
- Patients who have provided written informed consent to participate in the study.
- Patients with full-length standing lower limb radiographs showing a mechanical axis deviation of less than 10 degrees.
- Body mass index (BMI) between 18.5 and 35 kg/m².
Exclusion Criteria:
- Active joint infection or systemic infection.
- Presence of other joint diseases such as rheumatoid arthritis, gout, malignancy-related joint disease, or significant knee trauma.
- Acute concomitant medical conditions such as high fever, acute myocardial infarction, or pneumonia.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 10 days prior to enrollment or intra-articular corticosteroid injection within 3 months before enrollment.
- Presence of knee joint effusion at the time of screening.
- History of hypersensitivity or allergy to hyaluronic acid.
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 |
|---|---|
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実験的：Intra-articular Hyaluronic Acid Conjugated with Fibrinogen
Participants with knee osteoarthritis receive intra-articular injections of hyaluronic acid conjugated with fibrinogen according to routine clinical practice. This is a single-arm, post-marketing study evaluating effectiveness and safety outcomes. |
Participants with knee osteoarthritis receive intra-articular injections of hyaluronic acid conjugated with fibrinogen as part of routine clinical practice. The intervention is administered according to standard post-marketing use. This single-arm study evaluates the effectiveness and safety of the intervention without a comparator. |
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 |
|---|---|---|
|
Change from baseline in WOMAC total score
時間枠：Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
|
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. Scores range from 0 to 96, with higher scores indicating worse symptoms. |
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
|
|
Change from baseline in pain intensity at rest measured by Visual Analog Scale (VAS)
時間枠：Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
|
Pain intensity at rest is assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. |
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
|
|
Change from baseline in pain intensity during movement measured by Visual Analog Scale (VAS)
時間枠：Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
|
Pain intensity during movement is assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. |
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Lysholm Knee Scoring Scale
時間枠：Baseline, 3 months, 6 months, and 12 months
|
The Lysholm Knee Scoring Scale is used to assess knee function. Scores range from 0 to 100, with higher scores indicating better knee function. |
Baseline, 3 months, 6 months, and 12 months
|
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Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)
時間枠：Baseline, 3 months, 6 months, and 12 months
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Physical health-related quality of life is assessed using the Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS). Scores range from 0 to 100, with higher scores indicating better physical health. |
Baseline, 3 months, 6 months, and 12 months
|
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Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)
時間枠：Baseline, 3 months, 6 months, and 12 months
|
Mental health-related quality of life is assessed using the Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better mental health. |
Baseline, 3 months, 6 months, and 12 months
|
|
Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system
時間枠：Baseline and 12 months
|
Radiographic severity of knee osteoarthritis is assessed using standard knee X-ray and graded according to the Kellgren-Lawrence grading system (Grade 0-4), with higher grades indicating more severe osteoarthritis. |
Baseline and 12 months
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Incidence of adverse events following intra-articular hyaluronic acid-fibrinogen injection
時間枠：From baseline up to 12 months after intra-articular injection
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Safety is assessed by the incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) related to intra-articular injection of hyaluronic acid conjugated with fibrinogen. Adverse events include local reactions such as pain, swelling, joint effusion, and infection, as well as systemic adverse events occurring during the follow-up period. |
From baseline up to 12 months after intra-articular injection
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Manh Hung Tran, PhD、Head, Department of Pharmacology, School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
- 主任研究者：Nam Anh Tang Ha, MD, PhD、Xuong Khop Viet Clinic
出版物と役立つリンク
一般刊行物
- Kandel L, Agar G, Elkayam O, Sharipov A, Slevin O, Rivkin G, Dahan M, Aloush V, Pyeser AB, Brin Y, Beer Y, Yayon A. A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen - interim findings of a double-blind clinical study. Heliyon. 2020 Jul 23;6(7):e04475. doi: 10.1016/j.heliyon.2020.e04475. eCollection 2020 Jul.
- Han SB, Seo IW, Shin YS. Intra-Articular Injections of Hyaluronic Acid or Steroids Associated With Better Outcomes Than Platelet-Rich Plasma, Adipose Mesenchymal Stromal Cells, or Placebo in Knee Osteoarthritis: A Network Meta-analysis. Arthroscopy. 2021 Jan;37(1):292-306. doi: 10.1016/j.arthro.2020.03.041. Epub 2020 Apr 17.
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 24295 - ĐHYD
- 24295-DHYD (その他の識別子：University of Medicine and Pharmacy at Ho Chi Minh City (UMP))
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