Osteoarthritis of knee. Osteoarthritis of knee
Conditions
Interventions
Intervention 1: Intervention group: includes 40 patients who are treated with CHondroGrid (Bioteck) made of hydrolyzed collagen diluted in 2 cc of normal saline ?n three injections with two-week inter
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: People aged 40 to 70 years who are diagnosed with knee osteoarthritis based on history and physical examination. Duration of symptoms is more than 3 months. Confirmation of diagnosis using knee x-ray (Kellgren-Lawrence grade 2-3) The patient's BMI should be between 18 and 30. Willingness of the patient to participate in the study
Exclusion criteria
Exclusion criteria: History of immunodeficiency and collagen disorders and uncontrolled diabetes History or presence of malignant disorders, infection or active wound in the knee area Recent history of severe knee injury Autoimmune and platelet disorders Treatment with anticoagulant and antiplatelet drugs within 10 days before injection Use of NSAIDs within 2 days before injection History of intramuscular injection or oral use of systemic corticosteroids 2 weeks before injection History of any intra-articular injection of the knee during the last 6 months Hemoglobin less than 11 g/dL Platelet count less than 150,000/ml History of vasovagal shock Pregnancy or breastfeeding Geneva valgum/varum more than 20 degrees Hypersensitivity to hyaluronate Allergy to bovine proteins, poultry products, eggs and collagen Hemarthrosis, erythema and psoriatic lesions Clinical or para-clinical symptoms in favor of spinal canal narrowing, neuropathy or active lumbar radiculopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of knee pain. Timepoint: At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Visual analogue scale (VAS), WOMAC and Lequesne index questionnaire.;Assessing the patient's performance in daily tasks. Timepoint: At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Using the WOMAC questionnaire.;Assessment of morning stiffness. Timepoint: At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Using the WOMAC and Lequesne index questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| The degree of patient's satisfaction with the treatment. Timepoint: At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: 5-items questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Nazari Nodoushan
Shahid Beheshti University of Medical Sciences
Outcome results
None listed