Effectiveness and Safety of Intra-Articular Hyaluronic Acid Combined With Fibrinogen in Knee Osteoarthritis

Cao Kim Xoa

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Device: Intra-articular hyaluronic acid combined with fibrinogen

Study type: Interventional

Funder types: Other

Identifiers

NCT07323342

24295-DHYD (Other Identifier)

24295 - ĐHYD

Details and patient eligibility

About

This study aims to evaluate the effectiveness and safety of intra-articular injections of hyaluronic acid combined 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 a combination of hyaluronic acid and 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 combining hyaluronic acid with fibrinogen for the treatment of knee osteoarthritis.

Full description

This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of intra-articular hyaluronic acid combined 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 a combination of hyaluronic acid and 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.

Enrollment: 31 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Intra-articular combination Hyaluronic Acid and Fibrinogen

Experimental group

Description:

Participants with knee osteoarthritis receive intra-articular injections of hyaluronic acid combined with fibrinogen according to routine clinical practice. This is a single-arm, post-marketing study evaluating effectiveness and safety outcomes.

Treatment:

Device: Intra-articular hyaluronic acid combined with fibrinogen