Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Platelet-rich fibrin (PRF): The Intervention Group consists of the intra-articular application of PRF in the knee. The applications will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. A total of 3 applications of PRF will be conducted, with intervals of 14 to 28 days between them. 10ml of PRF will be applied intra-articularly, on an outpatient basis, with patients being instructed to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated.

Corticosteroid: The procedures will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. In this group, 40ml of peripheral blood will also be collected and placed for centrifugation. During the preparation for the application, a nurse (who will not participate in the study) will have a list of the randomization and will prepare the material in an opaque syringe (blinding both the applicator and the patient). In this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be administered in the first application and 10ml of saline in the second and third applications, with intervals of 14 to 28 days between the applications. The applications will be performed on an outpatient basis, with patients being advised to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated.

Study 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 of the knee. Inclusion criteria: Age 50 years or older, who have not improved with non-surgical treatment for at least 3 months, ability to sign informed consent, mean visual analogue scale \> 40/100 (over at least 7 days during the month anterior), mild or moderate knee arthrosis diagnosed by grade 2 or 3 radiographic imaging according to the Kellgren-Lawrence classification. Inclusion criteria: angular deviation \>10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane clinically evaluated with a goniometer (femur anatomical axis x tibial anatomical axis \> 4th varus or \> 16th valgus), BMI \>35 or \<18, smoking , autoimmune inflammatory disease - rheumatologic, diabetes - with glycated Hb \> 7, chronic kidney disease, coagulopathies, severe cardiovascular diseases, infections or immunodeficiencies, malignant neoplasm in activity or under treatment, use of NSAIDs in the last month, use of corticosteroids in the last 3 months, platelets \< 150,000, recent intra-articular corticosteroid infiltration or recent Hyaluronic acid infiltration (within the last 6 months), pregnancy or suspected pregnancy, psychiatric disorders. Exclusion criteria: when one of the investigators considers that the participant may be simulating a worse health state than the real one in order to receive financial assistance with the absence from work, he will be excluded from the work. Primary outcome: WOMAC. Secondary outcomes: Visual Analogue Pain Scale. Evaluation moments: inclusion and after the procedure at 3, 6, 12, 18 and 24 months. Sample calculation: 90 patients, 45 patients in each group, considering 15% loss to follow-up and aiming to reach a power of 0.8 and an alpha value of 0.5.

Eligibility

Primary outcome measure(s)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) — All outcomes will be evaluated at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months
  The following will be assessed: Western Ontario and McMaster Universities Arthritis Index (WOMAC) 0-100. The primary outcome will be WOMAC Pain subscale. The average time to complete these questionnaires is 10 minutes. All outcomes will be evaluated at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months. All patients will also be evaluated 2 weeks after the procedure to investigate possible complications.

Trial sites (1)

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