Platelet-rich fibrin compared with corticosteroid injections for knee osteoarthritis

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 or older with mild or moderate knee osteoarthritis (wear of the knee joint). Their knee pain has not improved with non-surgical treatment.

Age

50 years or older

Sex

All sexes

Disease stage

Mild or moderate knee osteoarthritis, grade 2 or 3 on X-ray by the Kellgren-Lawrence scale. Average pain score above 40/100 for at least 7 days in the previous month.

Earlier treatment

No improvement after non-surgical treatment for at least 3 months. No NSAIDs (anti-inflammatory painkillers) in the last month. No corticosteroids in the last 3 months. No knee injection of corticosteroid or HA in the last 6 months.

Biomarker or test result

Platelets must not be below 150,000. People with diabetes need HbA1c of 7 or less.

Main reasons for not taking part

• Knee bent inward or outward by more than 10º (over 4º varus or 16º valgus)
• BMI above 35 or below 18, or smoking
• Autoimmune rheumatic disease, chronic kidney disease, bleeding disorders, severe heart disease, infections or weak immune system
• Active or treated cancer, psychiatric disorders, pregnancy or possible pregnancy
• Off work on disability or worker's compensation benefits

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• CorticoidExisting treatment, for comparison

  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.

  Treatment: Corticosteroid

• platelet-rich fibrinTreatment being tested

  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.

  Treatment: Platelet-rich fibrin (PRF)