Effectiveness and Safety of Intra-Articular Hyaluronic Acid Combined With Fibrinogen in Knee Osteoarthritis
NCT ID: NCT07323342
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
31 participants
INTERVENTIONAL
2025-05-05
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Knee Injections on Patients With Knee Osteoarthritis
NCT05220527
Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis
NCT04972383
Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis
NCT03211650
Therapeutic Effect of Oral Hyaluronic Acid on Knee Osteoarthritis
NCT07033312
Comparative Effectiveness of Hyaluronic Acid Injections for Management of Knee Osteoarthritis
NCT02671565
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
45 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cao Kim Xoa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cao Kim Xoa
PhD Candidate, Clinical Pharmacology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nam Anh Tang Ha, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Xuong Khop Viet Clinic
Manh Hung Tran, PhD
Role: PRINCIPAL_INVESTIGATOR
Head, Department of Pharmacology, School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xuong Khop Viet clinic
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Han SB, Seo IW, Shin YS. Intra-Articular Injections of Hyaluronic Acid or Steroids Associated With Better Outcomes Than Platelet-Rich Plasma, Adipose Mesenchymal Stromal Cells, or Placebo in Knee Osteoarthritis: A Network Meta-analysis. Arthroscopy. 2021 Jan;37(1):292-306. doi: 10.1016/j.arthro.2020.03.041. Epub 2020 Apr 17.
David BM, Madsen BW, Ilett KF. Plasma binding of disopyramide. Br J Clin Pharmacol. 1980 Jun;9(6):614-8. doi: 10.1111/j.1365-2125.1980.tb01090.x. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24295-DHYD
Identifier Type: OTHER
Identifier Source: secondary_id
24295 - ĐHYD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.