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IRCT20260924071177N1 IRCT 2026-09-28 Hamedan University of Medical Sciences Compairing the effects of corticosteroids and PRP on treatment of knee osteoarthritis Comparing the effects of corticosteroids and PRP on the treatment of mild to moderated knee osteoarthritis: A duble blinded randomized clinical trial 2026-11-22 anticipated 22 Pending https://irct.ir/trial/93588 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be randomly allocated to the intervention groups using a permuted block randomization method with a block size of 4. Accordingly, four slips of paper of equal size and color will be prepared, with the letter A written on two of them and the letter B written on the other two. This method is similar to sampling without replacement. Upon enrollment of each eligible patient, one slip will be randomly selected. If the selected slip bears the letter A, the patient will be assigned to the PRP injection group, whereas if it bears the letter B, the patient will be assigned to the corticosteroid injection group. After a slip is selected, it will be removed from the pool, leaving three slips to randomly determine the treatment allocation of the next three eligible patients. At the end of each block, two patients will have been allocated to the PRP group and two patients to the corticosteroid group, thereby ensuring an equal sample size in the two treatment groups. This procedure will continue until the required sample size is reached, with patients being allocated equally to the two treatment groups under investigation, Blinding description: This study will be conducted using a double-blind design. Accordingly, the individual responsible for assessing the outcomes of osteoarthritis and knee injuries at the second and sixth months after treatment, as well as the patient and, ultimately, the individual responsible for data analysis, will be blinded to the type of injection administered to each knee. Specifically, they will be unaware of which knee received PRP and which knee received corticosteroid. To blind the patients and the outcome assessor, PRP and corticosteroid will be drawn into identical syringes by a nurse and labeled with codes before being provided to the surgeon for injection. Therefore, the patient and the outcome assessor will remain unaware of the type of injection administered until the pain scores and other outcome measures have been assessed. Finally, to blind the data analyst, the treatment arms will be entered into the software using codes A and B, and the coded dataset will be provided to the analyst for statistical analysis. Thus, the data analyst will remain unaware of the actual treatment allocation during the analysis. N/A Knee osteoarthritis. Intervention 1: First Intervention Group: Participants in the first intervention group will receive a single intra-articular injection of 8 mg dexamethasone (corticosteroid) under sterile conditions. Intervention 2: Second Intervention Group: Participants in the second intervention group will receive a single intra-articular injection of platelet-rich plasma (PRP) under sterile conditions. Briefly, 18 mL of peripheral venous blood will be collected from each participant and transferred into two sterile vacuum tubes, each containing 1 mL of anticoagulant. The blood samples will initially be centrifuged at 2,500 rpm for 10 minutes. Subsequently, the samples will undergo a second centrifugation at 1,500 rpm for 10 minutes. Following the second centrifugation step, approximately 3 mL of pure platelet-rich plasma (PRP) will be obtained and administered as a single intra-articular injection under sterile conditions. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan to share or disseminate the de-identified individual participant data after completion of this study. The data will be used solely for research purposes, statistical analysis, and reporting of the study results. The confidentiality of participants’ information will be maintained in accordance with ethical principles.
public Behzad Xeyati
Hamadan, Shahid Beheshti Boulevard, Besat Hospital
Hamedan Iran (Islamic Republic of) 6514845411 +98 81 3264 0020 Bahoooz.649@gmail.com Hamedan University of Medical Sciences scientific Behzad Xeyati
Hamadan, Shahid Beheshti Boulevard, Besat Hospital
Hamedan Iran (Islamic Republic of) 6514845411 +98 81 3264 0020 Bahoooz.649@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age over 50 years Morning stiffness lasting less than 30 minutes Crepitus during active knee movement Bony tenderness Bony enlargement Absence of evidence of septic arthritis of the knee 50 years no limit Both History of rheumatoid arthritis Evidence of septic arthritis History of intra-articular injection within the previous 6 months Any hematological disorder, including coagulopathy Injection phobia History of severe knee trauma Grade 3 osteoarthritis M17.0 Bilateral primary osteoarthritis of knee Treatment - Drugs Treatment - Drugs First Intervention Group: Participants in the first intervention group will receive a single intra-articular injection of 8 mg dexamethasone (corticosteroid) under sterile conditions. Second Intervention Group: Participants in the second intervention group will receive a single intra-articular injection of platelet-rich plasma (PRP) under sterile conditions. Briefly, 18 mL of peripheral venous blood will be collected from each participant and transferred into two sterile vacuum tubes, each containing 1 mL of anticoagulant. The blood samples will initially be centrifuged at 2,500 rpm for 10 minutes. Subsequently, the samples will undergo a second centrifugation at 1,500 rpm for 10 minutes. Following the second centrifugation step, approximately 3 mL of pure platelet-rich plasma (PRP) will be obtained and administered as a single intra-articular injection under sterile conditions. Pain score in patients with osteoarthritis, assessed using the KOOS questionnaire. Timepoint: The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection. Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire. Activities of Daily Living (ADL) Score Assessed Using the KOOS Questionnaire. Timepoint: The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection. Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire. Sport and Recreation Function Score in Patients with Osteoarthritis Assessed Using the KOOS Questionnaire. Timepoint: The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection. Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire. Knee-Related Quality of Life (QoL) Score Assessed Using the KOOS Questionnaire. Timepoint: The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection. Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire. Knee Stiffness Score Assessed Using the KOOS Questionnaire. Timepoint: The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection. Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire. Knee Symptoms Score in Patients with Osteoarthritis Assessed Using the KOOS Questionnaire. Timepoint: The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection. Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire. Hamedan University of Medical Sciences Approved 2026-09-12 Research Ethics Committee of Hamadan University of Medical Sciences Hamadan, Shahid Beheshti Boulevard, Besat Hospital Hamedan Hamadan Iran (Islamic Republic of)