NCT07323342

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

Evaluation of the Efficacy and Safety of Intra-Articular Hyaluronic Acid Combined With Fibrinogen in Patients With Knee Osteoarthritis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Cao Kim Xoa · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Intra-articular hyaluronic acid combined with fibrinogen	Participants with knee osteoarthritis receive intra-articular injections of hyaluronic acid combined 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.

Timeline

• Start date: 2025-05-05
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Vietnam