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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change from baseline in WOMAC total score [Time frame: 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) [Time frame: 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) [Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months]

Secondary outcome measures (5)

• Change from baseline in Lysholm Knee Scoring Scale [Time frame: Baseline, 3 months, 6 months, and 12 months]
• Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS) [Time frame: Baseline, 3 months, 6 months, and 12 months]
• Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS) [Time frame: Baseline, 3 months, 6 months, and 12 months]
• Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system [Time frame: Baseline and 12 months]
• Incidence of adverse events following intra-articular hyaluronic acid-fibrinogen injection [Time frame: From baseline up to 12 months after intra-articular injection]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Vietnam · 1 center

• Xuong Khop Viet clinic — Ho Chi Minh City

Publications

• 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
• 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

Identifiers

NCT: NCT07323342 · 24295 - ĐHYD · 24295-DHYD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗