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IRCT20160422027520N14 IRCT 2019-08-24 Pishtaz Teb Zaman CO. Treatment of chronic knee osteoarthritis with PRP with reduced Leukocyte content The effects of PRP with reduced Leukocyte content therapy on chronic knee osteoarthritis 2019-08-23 anticipated 15 Complete https://irct.ir/trial/41182 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The study participant will be unaware of his placement in the study group (PRP with reduced Leukocyte content or Leukocyte-Rich PRP ). 2 Osteoarthritis. Intervention 1: Intervention group: In this group of patients, 10 ml of blood will be taken by PRP-specific syringe manufactured by Pishtaz Teb Zaman CO. and according to kit protocol, we will separate the PRP with reduced Leukocyte content. The PRP will then be injected by a physician into one of the two knees of the patient with knee osteoarthritis. The PRP injection volume will be 2 cc.The injection will be repeated twice with a 21 days apart. Intervention 2: Control group: Leukocyte-rich PRP will be Prepared and by the physician will be injected into another patient's knee. The PRP injection volume will be 2 cc. The injection will be repeated twice with a 21 days apart. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mehdi Yousefi
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 4665 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mehdi Yousefi
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 4665 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Men and women between the ages of 18 and 75 with OA diagnosis based on the American College of Rheumatology Analog scale of knee pain (VAS) equal to or greater than 2.5 People with at least 4 months of history of pain or swelling in one or both knees Radiological classification scale Kellgren-Lawrence 1 or 2 The availability of individual during the study period BMI Between 20 and 35 18 years 75 years Both People under the age of 18 and over 75 years Pregnant women or women who are breastfeeding People with malignancy,People with severe heart disease, uncontrolled diabetes mellitus, rheumatoid arthritis, hemorrhagic diseases, history of anemia, arthritis, fibromyalgia and chronic fatigue syndrome People with acetaminophen or vicodin addiction or a history of drug misuse History of cortisone injections in the last 6 weeks The use of non-steroidal anti-inflammatory drugs 1 week ago Having hemoglobin less than 11 g / dl and platelet count less than 150000 / mμ The use of inhibitors of platelet aggregation and anti-coagulation such as heparin History of knee surgery in the last 3 months Extraordinary deformation (varus >5ᵒ, valgus >5ᵒ) M15.4 Erosive (osteo)arthritis Treatment - Other Treatment - Other Intervention group: In this group of patients, 10 ml of blood will be taken by PRP-specific syringe manufactured by Pishtaz Teb Zaman CO. and according to kit protocol, we will separate the PRP with reduced Leukocyte content. The PRP will then be injected by a physician into one of the two knees of the patient with knee osteoarthritis. The PRP injection volume will be 2 cc.The injection will be repeated twice with a 21 days apart. Control group: Leukocyte-rich PRP will be Prepared and by the physician will be injected into another patient's knee. The PRP injection volume will be 2 cc. The injection will be repeated twice with a 21 days apart. Determining knee pain. Timepoint: Before injection and 1, 3 and 6 months after the first injection. Method of measurement: Questionnaire (VAS). Determination of knee function. Timepoint: Before injection and 1, 3 and 6 months after the first injection. Method of measurement: Questionnaire (WOMAC), Questionnaire (KOOS). Determine the range of knee motion. Timepoint: Before injection and 1, 3 and 6 months after the first injection. Method of measurement: Manual joiniometry. Pishtaz Teb Zaman CO. Approved 2019-07-29 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences , Daneshghah st, Tabriz, Tabriz East Azarbaijan Iran (Islamic Republic of)