Knee OsteoarthritisNCT07323342
Effectiveness and Safety of Intra-Articular Hyaluronic Acid Conjugated With Fibrinogen in Knee Osteoarthritis
A study testing Intra-articular hyaluronic acid conjugated with fibrinogen in people with Knee Osteoarthritis, run by Cao Kim Xoa at 1 site in Vietnam.
Trial summary
This study aims to evaluate the effectiveness and safety of intra-articular injections of hyaluronic acid conjugated 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intra-articular hyaluronic acid conjugated with fibrinogen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteVietnam
- Study dates
- 5 May 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nam Anh Tang Ha, PhD contact
Vietnam1 site, 1 recruiting
- Recruiting
Xuong Khop Viet clinic
Ho Chi Minh City, 700000
Cao Kim Xoa, Msc, +84 987111194, Caokimxoa.ump@gmail.com
About this study
Official title: Evaluation of the Efficacy and Safety of Intra-Articular Hyaluronic Acid Conjugated With Fibrinogen in Patients With Knee Osteoarthritis
This study aims to evaluate the effectiveness and safety of intra-articular injections of hyaluronic acid conjugated 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.
Read more
In this single-arm clinical study, patients with knee osteoarthritis will receive intra-articular injections of hyaluronic acid conjugated with 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 conjugating hyaluronic acid with fibrinogen for the treatment of knee osteoarthritis.
Read the detailed description
This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of intra-articular hyaluronic acid conjugated 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 hyaluronic acid conjugated with 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
- Knee Osteoarthritis
- Being tested
- Intra-articular hyaluronic acid conjugated with fibrinogen
- Keywords
- Knee osteoarthritis, Hyaluronic acid, Intra-articular injection, Pain management
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular hyaluronic acid conjugated with fibrinogenDevice
Participants with knee osteoarthritis receive intra-articular injections of hyaluronic acid conjugated 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.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Hyaluronic Acid Conjugated with Fibrinogen | Experimental | Participants with knee osteoarthritis receive intra-articular injections of hyaluronic acid conjugated with fibrinogen according to routine clinical practice. This is a single-arm, post-marketing study evaluating effectiveness and safety outcomes. Receives: Device: Intra-articular hyaluronic acid conjugated with fibrinogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
Secondary outcomes (5)
Change from baseline in Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is used to assess knee function. Scores range from 0 to 100, with higher scores indicating better knee function.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)
Physical health-related quality of life is assessed using the Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS). Scores range from 0 to 100, with higher scores indicating better physical health.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)
Mental health-related quality of life is assessed using the Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better mental health.
Measured: Baseline, 3 months, 6 months, and 12 months
Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system
Radiographic severity of knee osteoarthritis is assessed using standard knee X-ray and graded according to the Kellgren-Lawrence grading system (Grade 0-4), with higher grades indicating more severe osteoarthritis.
Measured: Baseline and 12 months
Incidence of adverse events following intra-articular hyaluronic acid-fibrinogen injection
Safety is assessed by the incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) related to intra-articular injection of hyaluronic acid conjugated with fibrinogen. Adverse events include local reactions such as pain, swelling, joint effusion, and infection, as well as systemic adverse events occurring during the follow-up period.
Measured: From baseline up to 12 months after intra-articular injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start5 May 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm interventional study in which all participants receive intra-articular hyaluronic acid conjugated with fibrinogen.
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cao Kim Xoa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cao Kim Xoa, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Nam Anh Tang Ha, MD, PhD, Principal investigator, Xuong Khop Viet ClinicManh Hung Tran, PhD, Principal investigator, Head, Department of Pharmacology, School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323342
- Sponsor's protocol ID
- 24295 - ĐHYD
- Other IDs
- 24295-DHYD
- Status last verified
- Sep 2026
- First submitted
- 16 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32305424Kandel 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.
PubMed 32743094
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Intra-Articular Hyaluronic Acid Conjugated With Fibrinogen in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07323342
- Acronym / sponsor ID
- 24295 - ĐHYD
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Hyaluronic acid, Intra-articular injection, Pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Cao Kim XoaUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness and safety of intra-articular injections of hyaluronic acid conjugated 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 hyaluronic acid conjugated with 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 conjugating 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 conjugated 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 hyaluronic acid conjugated with 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm interventional study in which all participants receive intra-articular hyaluronic acid conjugated with fibrinogen.
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Hyaluronic Acid Conjugated with Fibrinogen | Experimental | Device: Intra-articular hyaluronic acid conjugated with fibrinogenParticipants with knee osteoarthritis receive intra-articular injections of hyaluronic acid conjugated with fibrinogen according to routine clinical practice. This is a single-arm, post-marketing study evaluating effectiveness and safety outcomes. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular hyaluronic acid conjugated with fibrinogenParticipants with knee osteoarthritis receive intra-articular injections of hyaluronic acid conjugated 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. | Device | Intra-articular Hyaluronic Acid Conjugated with Fibrinogen |
Primary outcome
Change from baseline in WOMAC total score
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
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.
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
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.
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
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Results publication: PubMed 32305424Han 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.
- Results publication: PubMed 32743094Kandel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nam Anh Tang Ha, PhD contact
Nam Anh Tang Ha, MD, PhD principal investigator
Xuong Khop Viet Clinic
Manh Hung Tran, PhD principal investigator
Head, Department of Pharmacology, School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular hyaluronic acid conjugated with fibrinogen in people with Knee Osteoarthritis, run by Cao Kim Xoa at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Xoa Cao, MSc in Pharmacy (+84 987111194, caokimxoa.ump@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in WOMAC total score (time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07323342, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.