Eficácia e Segurança do Ácido Hialurônico Intra-Articular Combinado com Fibrinogênio na Osteoartrite do Joelho
Avaliação da Eficácia e Segurança do Ácido Hialurónico Intra-Articular Combinado com Fibrinogénio em Doentes com Osteoartrose do Joelho
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ho Chi Minh City, Vietnã, 700000
- Xuong Khop Viet clinic
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in WOMAC total score
Prazo: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
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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
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Change from baseline in pain intensity at rest measured by Visual Analog Scale (VAS)
Prazo: 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
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Change from baseline in pain intensity during movement measured by Visual Analog Scale (VAS)
Prazo: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months
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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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in Lysholm Knee Scoring Scale
Prazo: Baseline, 3 months, 6 months, and 12 months
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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
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Change from baseline in physical health measured by SF-36 Physical Component Summary (PCS)
Prazo: Baseline, 3 months, 6 months, and 12 months
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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
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Change from baseline in mental health measured by SF-36 Mental Component Summary (MCS)
Prazo: 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
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Radiographic severity of knee osteoarthritis assessed by Kellgren-Lawrence grading system
Prazo: Baseline and 12 months
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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
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Incidence of adverse events following intra-articular hyaluronic acid-fibrinogen injection
Prazo: From baseline up to 12 months after intra-articular injection
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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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: 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
- Investigador principal: Nam Anh Tang Ha, MD, PhD, Xuong Khop Viet Clinic
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 24295 - ĐHYD
- 24295-DHYD (Outro identificador: University of Medicine and Pharmacy at Ho Chi Minh City (UMP))
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