关节内透明质酸联合纤维蛋白原治疗膝骨关节炎的有效性与安全性
评估关节内透明质酸联合纤维蛋白原治疗膝骨关节炎患者的疗效与安全性
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Ho Chi Minh City、越南、700000
- Xuong Khop Viet clinic
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in WOMAC total score
大体时间：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)
大体时间：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)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Lysholm Knee Scoring Scale
大体时间：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
|
|
Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)
大体时间：Baseline, 3 months, 6 months, and 12 months
|
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
|
|
Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)
大体时间：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
大体时间：Baseline and 12 months
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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
大体时间：From baseline up to 12 months after intra-articular injection
|
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
|
合作者和调查者
赞助
调查人员
- 首席研究员：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
- 首席研究员：Nam Anh Tang Ha, MD, PhD、Xuong Khop Viet Clinic
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 24295 - ĐHYD
- 24295-DHYD (其他标识符：University of Medicine and Pharmacy at Ho Chi Minh City (UMP))
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