Hyaluronic acid plus fibrinogen injections for knee osteoarthritis
Evaluation of the Efficacy and Safety of Intra-Articular Hyaluronic Acid Combined With Fibrinogen in Patients With Knee Osteoarthritis
This trial will try injections of hyaluronic acid combined with fibrinogen to reduce pain and improve function in adults with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | University of Medicine and Pharmacy at Ho Chi Minh City Academic / other |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT07323342 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm study in which eligible patients with knee osteoarthritis will receive intra-articular injections of a hyaluronic acid and fibrinogen combination. Patients will be enrolled based on clinical and radiographic criteria and will be followed at scheduled visits to record pain, functional scores, quality of life, and any adverse events. Outcomes will be measured with validated clinical scales and safety will be monitored throughout the follow-up period. The protocol is conducted under the supervision of the University of Medicine and Pharmacy at Ho Chi Minh City and administered at a local clinic.
Who should consider this trial
Good fit: Ideal candidates are Vietnamese adults aged 45–75 with primary knee osteoarthritis by ACR criteria, BMI 18.5–35 kg/m², a mechanical axis deviation under 10 degrees on full-length radiographs, and who can give informed consent.
Not a fit: Patients with active joint or systemic infection, inflammatory arthritides (like rheumatoid arthritis or gout), recent intra-articular corticosteroid injection, current knee effusion, or serious acute medical conditions are unlikely to benefit or qualify.
Why it matters
Potential benefit: If successful, the combination could reduce knee pain and improve mobility for people with knee osteoarthritis.
How similar studies have performed: Hyaluronic acid injections have mixed evidence for symptom relief in knee osteoarthritis, and adding fibrinogen is a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ho Chi Minh City
- Xuong Khop Viet clinic — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Principal investigator: Nam Anh Tang Ha, MD, PhD — Xuong Khop Viet Clinic
- Study coordinator: Kim Xoa Cao, MSc in Pharmacy
- Email: caokimxoa.ump@gmail.com
- Phone: +84 987111194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.