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Effektivitet og sikkerhed af intra-articulær hyaluronsyre kombineret med fibrinogen ved knæartrose

5. november 2026 opdateret af: Cao Kim Xoa

Evaluering af effektiviteten og sikkerheden af intraartikulær hyaluronsyre kombineret med fibrinogen hos patienter med knæartrose

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Xuong Khop Viet clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intra-articular Hyaluronic Acid Conjugated with Fibrinogen

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.
Enhed: Intra-articular hyaluronic acid conjugated with fibrinogen

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in WOMAC total score
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Lysholm Knee Scoring Scale
Tidsramme: Baseline, 3 months, 6 months, and 12 months

The Lysholm Knee Scoring Scale is used to assess knee function. Scores range from 0 to 100, with higher scores indicating better knee function.
Baseline, 3 months, 6 months, and 12 months
Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)
Tidsramme: Baseline, 3 months, 6 months, and 12 months

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.
Baseline, 3 months, 6 months, and 12 months
Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)
Tidsramme: Baseline, 3 months, 6 months, and 12 months

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.
Baseline, 3 months, 6 months, and 12 months
Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system
Tidsramme: Baseline and 12 months

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.
Baseline and 12 months
Incidence of adverse events following intra-articular hyaluronic acid-fibrinogen injection
Tidsramme: From baseline up to 12 months after intra-articular 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.
From baseline up to 12 months after intra-articular injection

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cao Kim Xoa

Efterforskere

  • Ledende efterforsker: 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
  • Ledende efterforsker: Nam Anh Tang Ha, MD, PhD, Xuong Khop Viet Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. maj 2024

Primær færdiggørelse (Faktiske)

5. oktober 2026

Studieafslutning (Faktiske)

5. oktober 2026

Datoer for studieregistrering

Først indsendt

16. december 2025

Først indsendt, der opfyldte QC-kriterier

31. december 2025

Først opslået (Faktiske)

7. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 24295 - ĐHYD
  • 24295-DHYD (Anden identifikator: University of Medicine and Pharmacy at Ho Chi Minh City (UMP))

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