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.
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.
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.
Single group
Intra-articular hyaluronic acid conjugated with fibrinogen
DeviceParticipants 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.
Change from baseline in WOMAC total score
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)
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)
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.
Change from baseline in Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is used to assess knee function. Scores range from 0 to 100, with higher scores indicating better knee function.
Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)
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.
Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)
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.
Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system
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.
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Cao Kim Xoa
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor institution