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IRCT20170608034390N3 IRCT 2019-06-13 Shahid Beheshti University of Medical Sciences Assessing the Efficacy of Intra-articular Injection of High Molecular Weight Hyaluronic Acid on Knee Function of Patients with Tibial Plateau Fracture after Surgical Fixation Evaluating the Efficacy of Intra-articular Injection of High molecular weight Hyaluronic Acid on the Knee Performance of Patient with Tibial Plateau Fracture after Surgical Intervention 2018-05-16 anticipated 32 Complete https://irct.ir/trial/39203 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With block randomization and allocation the patients into eight blocks with four patients in each group, Blinding description: All Participants, Investigators, Outcome assessors, Data analyst and quality controller are blinded, however as the viscosity of the Hyaluronic Acid are dramatically higher than normal saline solution used as placebo, it was impossible to blind the practitioner who will do the injections, so an independent physician handled the injections. 2-3 Tibial Plateau Fracture. Intervention 1: Control group:intra-articular injections of 2 ml Normal Saline in 2, 4 weeks after surgery, under sterile conditions and by an orthopedic specialist. Intervention 2: Intervention group: intra-articular injections of 2 ml High Molecular Weight Hyaluronic Acid in 2, 4 weeks after surgery, under sterile conditions and by an orthopedic specialist. Yes - There is a plan to make this available What will be shared: The whole potential data is unpublished after being unidentifiable. When: Start the access period 6 months after printing the results. To whom: Researchers working in academic and industrial institutions. Conditions: Researchers working in academic and industrial institutions. Where to obtain: Dr. Hadi Esmaily, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences. How to obtain: After sending a request it will be available Comments:
public Hadi Esmaily
Shahid Beheshti, Faculty of Pharmacy, Vali Ars AVe
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8887 3704 esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hadi Esmaily
Shahid Beheshti, Faculty of Pharmacy, Vali Ars AVe
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8887 3704 esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Adults (18-65 years) Tibial Plateau Fracture Signing the Informed Consent 18 years 65 years Both Pregnancy & Lactation Diabetes Mellitus Severe osteoarthritis Sever Osteoporesis Non-surgical patients (Active septic disorders of knee joint and tissues around the knee, Coagulopathies, Active rheumatologic disorders, Heart Failure, COPD, ....) Open fractures Failure to perform internal fixation due to extensive tissue damage S82.1 Fracture of upper end of tibia Placebo Treatment - Drugs Control group:intra-articular injections of 2 ml Normal Saline in 2, 4 weeks after surgery, under sterile conditions and by an orthopedic specialist Intervention group: intra-articular injections of 2 ml High Molecular Weight Hyaluronic Acid in 2, 4 weeks after surgery, under sterile conditions and by an orthopedic specialist Pain by Visual Analogue Scale (VAS) score. Timepoint: Starting point, 2 and 22 weeks after first Injection. Method of measurement: Using standard scale for VAS score. Range of Motion. Timepoint: Starting point (2 weeks after fixation operation), 2 and 22 weeks after first Injection. Method of measurement: Using goniometer. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score). Timepoint: Starting point, 2 and 22 weeks after first Injection. Method of measurement: Using validated questionnaire of WOMAC Score. Shahid Beheshti University of Medical Sciences Approved 2018-05-15 National ethics ommittee for biomedical research Central Department of Ministerial of Health and Medical Education, Sima Iran St, between South Falamak and Zarafshan St, Shark Gharb Tehran Tehran Iran (Islamic Republic of)