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

Sponsor: Cao Kim Xoa • ClinicalTrials.gov ID: NCT07323342

Registry updated: 2026-09-03

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Description

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.

Interventions

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.

Eligibility criteria

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.

Conditions

Knee Osteoarthritis

Locations

Xuong Khop Viet clinic — Ho Chi Minh City, Vietnam

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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