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IRCT20130523013442N30 IRCT 2019-11-29 Shahid Beheshti University of Medical Sciences Effect of ultrasound guided intra articular injection of platelet rich plasma(PRP), hyaluronic acid(HA) and combined PRP and HA in patients with hip osteoarthritis Effect of ultrasound guided intra articular injection of platelet rich plasma(PRP), hyaluronic acid(HA) and combined PRP and HA in patients with hip osteoarthritis 2019-06-04 anticipated 60 Complete https://irct.ir/trial/39553 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 hip joints along with consistent imaging findings would be enrolled and randomly allocated into three groups of platelet rich plasma versus hyaluronic acid and the combination of these two, 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 hip osteoarthritis. Intervention 1: Intervention group: platelet rich plasma , hip intraarticular injection, 4 to 6 milliliter, 2 times, 2 weeks interval. Intervention 2: Intervention group: Hyaluronic acid (molecular weight more than 3000 kilo Daltons),2times, 2 weeks interval. Intervention 3: Intervention group: Hyaluronic acid (molecular weight more than 3000 kilo Daltons) and platelet rich plasma , hip intraarticular injection,2times, 2 weeks interval. 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 more information.
public Parya Peydayesh
Saadat Abad St.
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 paryapey@gmail.com Shahid Modarres Hospital 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 Modarres Hospital Iran (Islamic Republic of) Patients with hip osteoarthritis based on American College of Rheumatology criteria at the age of 70-40 years and with the duration of symptoms more than three months that are recognized by hip x-ray (Grade 2 and 3) at the age of 70-40 years duration of symptoms more than three months Grade 2 and 3 recognized by hip x-ray 40 years 70 years Both Systemic diseases such as diabetes mellitus,collagen vascular disorders or immune deficiency History of malignancy Hip infection or active wound History of NSAIDs usage within 2 days before injection Patients who were under anticoagulant or antiplatelet treatments within 10 days before injection Hemoglobin < 12 and plt < 150000 History of severe hip trauma Pregnancy and breastfeeding Allergy to protein of egg , feather or hypersensitivity to hyaluronate M16 Osteoarthritis of hip Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: platelet rich plasma , hip intraarticular injection, 4 to 6 milliliter, 2 times, 2 weeks interval Intervention group: Hyaluronic acid (molecular weight more than 3000 kilo Daltons),2times, 2 weeks interval Intervention group: Hyaluronic acid (molecular weight more than 3000 kilo Daltons) and platelet rich plasma , hip intraarticular injection,2times, 2 weeks interval Hip pain. Timepoint: before intervention,2 months & 6months after intervention. Method of measurement: changes of WOMAC and VAS and LEQUESNE questionnaires scores. Joint stiffness. Timepoint: before intervention,2 months & 6 months after intervention. Method of measurement: change of WOMAC questionnaire scores. Function. Timepoint: before intervention,2 months & 6 months after intervention. Method of measurement: change of WOMAC questionnaire scores. Activity of daily living. Timepoint: before intervention,2 months & 6 months after intervention. Method of measurement: change of LEQUESNE questionnaire scores. Shahid Beheshti University of Medical Sciences Approved 2019-05-04 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Arabi Ave., Yaman St., Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)