Effectiveness and Safety of Intra-Articular Hyaluronic Acid Conjugated With Fibrinogen in Knee Osteoarthritis
Knee Osteoarthritis
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 45 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 31 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
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.
Device: Intra-articular hyaluronic acid conjugated with fibrinogen
Intra-articular hyaluronic acid conjugated with fibrinogen DEVICE
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change from baseline in WOMAC total score
Time frame: 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)
Time frame: 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)
Time frame: 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.
Secondary measures
Change from baseline in Lysholm Knee Scoring Scale
Time frame: 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.
Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)
Time frame: 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.
Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)
Time frame: 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.
Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system
Time frame: 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.
Incidence of adverse events following intra-articular hyaluronic acid-fibrinogen injection
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Xuong Khop Viet clinicHo Chi Minh City, VietnamStatus unknown
Study team and timeline
- Lead sponsor
- Cao Kim Xoa
- Study start
- May 5, 2024 Actual
- Primary completion
- Oct 5, 2026 Actual
- Study completion
- Oct 5, 2026 Actual
- First posted
- Jan 7, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Evaluation of the Efficacy and Safety of Intra-Articular Hyaluronic Acid Conjugated With Fibrinogen in Patients With Knee Osteoarthritis
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026