Evaluation of the Efficacy and Safety of Intra-Articular Hyaluronic Acid Conjugated With Fibrinogen in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change from baseline in WOMAC total score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intra-articular hyaluronic acid conjugated with fibrinogen (Device)
结局指标
主要结局
Change from baseline in WOMAC total score
时间窗: 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.
Change from baseline in pain intensity at rest measured by Visual Analog Scale (VAS)
时间窗: 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.
Change from baseline in pain intensity during movement measured by Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Change from baseline in Lysholm Knee Scoring Scale(Baseline, 3 months, 6 months, and 12 months)
- Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system(Baseline and 12 months)
- Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)(Baseline, 3 months, 6 months, and 12 months)
- Incidence of adverse events following intra-articular hyaluronic acid-fibrinogen injection(From baseline up to 12 months after intra-articular injection)
研究者
Cao Kim Xoa
PhD Candidate, Clinical Pharmacology
University of Medicine and Pharmacy at Ho Chi Minh City