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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Viet Nam
Xuong Khop Viet clinic
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Kim Xoa Cao, MSc in Pharmacy
caokimxoa.ump@gmail.com
+84 987111194
Backup
Nam Anh Tang Ha, PhD
tanghanamanh@yahoo.fr
Time Frame
Start Date: 2025-05-05
Estimated Completion Date: 2026-10
Participants
Target number of participants: 31
Treatments
Experimental: Intra-articular combination Hyaluronic Acid and Fibrinogen
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.
Related Therapeutic Areas
Sponsors
Leads: Cao Kim Xoa

This content was sourced from clinicaltrials.gov

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