Comparison of intra-articular injection of hydrolyzed type 1 collagen, platelet-rich plasma and hyaluronic acid on pain, stiffness and performance of patients with knee osteoarthritis

Phase 3

Recruiting

Conditions: Osteoarthritis of knee.
Osteoarthritis of knee

Registration Number: IRCT20130523013442N34

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.