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IRCT20130523013442N23 IRCT 2018-03-24 Vice chancellor for research, Shahid Beheshti University of Medical Sciences Efficacy of intra-articular injection of a newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid on pain and function of patients with knee osteoarthritis Efficacy of intra-articular injection of a newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid on pain and function of patients with knee osteoarthritis: A single-blinded randomized clinical trial 2018-02-19 anticipated 60 Complete https://irct.ir/trial/29336 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study a total of 60 patients with more than three months of chronic pain in the knee joints along with consistent imaging findings (Kellgren-Lawrence score of Ⅱ&Ⅲ) would be enrolled and randomly allocated into two groups of plasma rich in growth factors (PRGF) versus hyaluronic acid, Blinding description: Random table number is used to randomize. This is a single blind study and patients are not aware of the type of injected drug. N/A Knee osteoarthritis. Intervention 1: Intervention group 1: plasma rich in growth factor, knee intraarticular injection, 4 to 6 milliliter, 2 times, 3 weeks interval. Intervention 2: Intervention group 2 : Hyaluronic acid (500,000 to 730000 Daltons),3times, weekly. 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 There is no further information
public Pegah Yavari
Shahid Modarres hospital, Kaj square, Saadat abad street
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2200 8941 yavari@sbmu.ac.ir Physical Medicine and Rehabilitation Department, Shahid Beheshti University of Medical Sciences, Sch scientific Seyed Ahmad Raeissadat
Shahid Arabi Ave., Yaman St., Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 a_raeissadat@sbmu.ac.ir Shahid Beheshti Univeraity of Medical Sciences Iran (Islamic Republic of) Age between 45-75 years Symptomatic knee OA with the pain aggravated by weight bearing Symptoms lasting for at least 6 months despite conservative treatment Kellgren-Lawrance radiology scoring system scores ranging from 2-3 45 years 75 years Both History of trauma , surgery or any invasive procedure in the affected joint during the past 6 months Mal-alignment in lower limbs and abnormal blood count or impared coagulation test Pregnant women Patients who were under immunosuppressant treatments Those with an underlying systemic arthropathy (secondary OA) Patients been treated with angiotensin converting enzyme inhibitors (ACE I) and significant deficiency in glucose 6 - phosphate dehydrogenase (G6PD) level M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group 1: plasma rich in growth factor, knee intraarticular injection, 4 to 6 milliliter, 2 times, 3 weeks interval Intervention group 2 : Hyaluronic acid (500,000 to 730000 Daltons),3times, weekly Knee Pain. Timepoint: Before intervention, 6 months & 12months after intervention. Method of measurement: Change of WOMAC questionnaire scores. Vice chancellor for research, Shahid Beheshti University of Medical Sciences Approved 2017-12-31 Ethic Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Sahahid Arabi street, Yaman street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)