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

NCT07323342 | Recruiting

• 2 other identifiers: 24295 - ĐHYD24295-DHYD
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Hyaluronic acid; Intra-articular injection; Pain management

Outcome Measures

Primary Outcomes (3)

• Change from baseline in WOMAC total score

  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. Scores range from 0 to 96, with higher scores indicating worse symptoms.

  Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months

• Change from baseline in pain intensity at rest measured by Visual Analog Scale (VAS)

  Pain intensity at rest is assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

  Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months

• Change from baseline in pain intensity during movement measured by Visual Analog Scale (VAS)

  Pain intensity during movement is assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

  Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months

Secondary Outcomes (5)

• Change from baseline in Lysholm Knee Scoring Scale

  Baseline, 3 months, 6 months, and 12 months

• Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)

  Baseline, 3 months, 6 months, and 12 months

• Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)

  Baseline, 3 months, 6 months, and 12 months

• Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system

  Baseline and 12 months

• Incidence of adverse events following intra-articular hyaluronic acid-fibrinogen injection

  From baseline up to 12 months after intra-articular injection

Study Arms (1)

Intra-articular combination Hyaluronic Acid and Fibrinogen

EXPERIMENTAL

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.

Device: Intra-articular hyaluronic acid combined with fibrinogen

Interventions

Intra-articular hyaluronic acid combined with fibrinogen DEVICE

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.

Intra-articular combination Hyaluronic Acid and Fibrinogen

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cao Kim Xoa: lead

Study Sites (1)

Xuong Khop Viet clinic

Ho Chi Minh City, 700000, Vietnam

RECRUITING

Related Publications (2)

• 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.

  PMID: 32305424 RESULT

• Kandel L, Agar G, Elkayam O, Sharipov A, Slevin O, Rivkin G, Dahan M, Aloush V, Pyeser AB, Brin Y, Beer Y, Yayon A. A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen - interim findings of a double-blind clinical study. Heliyon. 2020 Jul 23;6(7):e04475. doi: 10.1016/j.heliyon.2020.e04475. eCollection 2020 Jul.

  PMID: 32743094 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nam Anh Tang Ha, MD, PhD

  Xuong Khop Viet Clinic

  PRINCIPAL INVESTIGATOR

• Manh Hung Tran, PhD

  Head, Department of Pharmacology, School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Xoa Cao, MSc in Pharmacy

CONTACT

+84 987111194; caokimxoa.ump@gmail.com

Nam Anh Tang Ha, PhD

CONTACT

tanghanamanh@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate, Clinical Pharmacology

Model Details: This is a single-arm interventional study in which all participants receive intra-articular hyaluronic acid combined with fibrinogen.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 7, 2026
• Study Start: May 5, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)