Status:
NOT_YET_RECRUITING
Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis
Lead Sponsor:
Federal University of São Paulo
Conditions:
Gonarthrosis; Primary
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Methodology: Randomized double-blind clinical trial comparing intra-articular injection of Platelet-Rich Fibrin (PRF) versus intra-articular injection of corticosteroids in mild to moderate arthrosis ...
Detailed Description
The objective of this work is to compare the efficacy of intra-articular injection of PRF versus intra-articular application of corticosteroid in the treatment of patients with mild to moderate knee o...
Eligibility Criteria
Inclusion
- The following inclusion criteria will be followed:
- Age 50 years or older
- Who have not improved with non-surgical treatment for at least 3 months, ability to sign a consent form, average visual analog scale \> 40/100 (over at least 7 days in the previous month)
- Mild or moderate knee osteoarthritis diagnosed by radiographic imaging grade 2 or 3 according to the Kellgren-Lawrence classification.
Exclusion
- The exclusion criteria will be:
- Absence from work due to disability benefits or income reduction assistance (worker's compensation). Whenever one of the investigators believes that a participant may be simulating a worse health condition than reality to receive financial assistance with work absence, they will be excluded from the study.
- The following non-inclusion criteria will be observed:
- Angular deviation \>10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane assessed clinically with a goniometer (anatomical axis of the femur x anatomical axis of the tibia \> 4º varus or \> 16º valgus)
- Body Mass Index (BMI)\>35 or \<18
- Smoking
- Autoimmune inflammatory disease - rheumatological
- Diabetes - with HbA1c \> 7
- Chronic kidney disease
- Coagulopathies
- severe cardiovascular diseases
- infections or immunodeficiencies
- active or treated malignant neoplasia
- use of NSAIDs in the last month
- use of corticosteroids in the last 3 months
- platelets \< 150,000
- recent intra-articular corticosteroid injection or recent HA injection (in the last 6 months)
- pregnancy or suspected pregnancy
- psychiatric disorders.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06905860
Start Date
June 1 2025
End Date
September 1 2027
Last Update
April 2 2025
Active Locations (1)
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1
Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil, 04023-062