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IRCT20210423051054N1 IRCT 2022-05-11 Shahid Beheshti University of Medical Sciences The effect of exosomes in the treatment of knee osteoarthritis Evaluation of therapeutic effect of placental mesenchymal stem cell exosome injection in improving clinical symptoms and MRI changes in patients with knee osteoarthritis 2022-06-22 anticipated 30 Complete https://irct.ir/trial/55913 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, 30 patients with bilateral osteoarthritis of the knee, referred to the physical medicine and rehabilitation clinic of Taleghani Hospital in Tehran, will be randomly entered into the study. Random Allocation software will be used for random assignment of samples. Random sequences from 1 to 30 will be created using this software. Random allocation concealment method will be used for hiding. In this way, the created sequences are recorded on cards and these cards will be placed in sealed envelopes. Then, according to the order of entry of eligible people to study, each envelope will be opened and their assigned number will be determined. Thus, if the desired number was even, the right knee will be selected as the intervention and the left knee as the control, and if the desired number is odd, the left knee will be selected as the intervention and the right knee as the control, Blinding description: According to the codings performed for patients and drugs, all patients, caregivers, data collector, people who evaluate the outcomes, as well as data analyzer, for the intervention performed in each patient (drug or Placebo) are unaware. Both knees of the patient are injected. Drug is injected in one knee and placebo in the other, randomly. 3 Knee osteoarthritis. Intervention 1: Intervention group: Injection of 5 cc of placental mesenchymal stem cell exosome into the knee with anterolateral approach in the flexed position, isometric strengthening exercises for quadriceps, adductor and abductor muscles of the thigh (10 times and each time for 10 seconds), 2 times a day, and stretching of hamstrings (3 times and each time for 30 seconds), 2 times a day. Intervention 2: Control group: Injection of 5 cc of normal saline into the knee with anterolateral approach in the flexed position, isometric strengthening exercises for quadriceps, adductor and abductor muscles of the thigh (10 times and each time for 10 seconds), 2 times a day, and stretching of hamstrings (3 times and each time for 30 seconds), 2 times a day. 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 Rasa Salmani Oshnari
Shohadaye Tajrish Hospital, Shahrdari St, Tajrish Sq
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 rasa_salmani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Najmeh Sadat Bolandnazar
Taleghani Hospital, Yaman St, Shahid Chamran Hwy
Tehran Iran (Islamic Republic of) 1115119857 +98 21 2243 2560 n.sadat.bolandnazar@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Pain in both knees over the past 6 months, which is related to the degenerative process of the knee, requires pain medication and has lasted for more than a month. Graphical confirmation of bilateral knee osteoarthritis with grade 2 or 3 based on the Kellgren-Lawrence classification. The knee pain intensity should be greater than or equal to 4 according to the VAS. 45 years 65 years Both Younger than 45 years or older than 65 years Rheumatic or collagen vascular disease History of malignancy Coagulopathy or taking anticoagulant drug Any injection into the knee joint during the last 3 months A history of recent severe knee trauma in the past 1 month Septic arthritis of the knee or active wound of the knee joint Genovarum or genovalgum greater than 20 degrees Total knee replacement Cardiac pacemaker Cochlear implantation Existence of fragments or foreign metal object in the knee or around the arteries, nerves and brain M17.0 Bilateral primary osteoarthritis of knee Treatment - Drugs Placebo Intervention group: Injection of 5 cc of placental mesenchymal stem cell exosome into the knee with anterolateral approach in the flexed position, isometric strengthening exercises for quadriceps, adductor and abductor muscles of the thigh (10 times and each time for 10 seconds), 2 times a day, and stretching of hamstrings (3 times and each time for 30 seconds), 2 times a day. Control group: Injection of 5 cc of normal saline into the knee with anterolateral approach in the flexed position, isometric strengthening exercises for quadriceps, adductor and abductor muscles of the thigh (10 times and each time for 10 seconds), 2 times a day, and stretching of hamstrings (3 times and each time for 30 seconds), 2 times a day. Pain intensity. Timepoint: Before intervention, 2 and 6 months after intervention. Method of measurement: Visual Analogue Scale. Pain intensity, stiffness, and physical activity. Timepoint: Before intervention, 2 and 6 months after intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index. Pain or discomfort, maximum distance walked, and activities of daily living. Timepoint: Before intervention, 2 and 6 months after intervention. Method of measurement: Lequesne Index. Patellofemoral cartilage volume. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging. Tibiofemoral cartilage volume. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging. Knee joint synovitis. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging. Medial and lateral meniscus disintegration. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging. Patellofemoral cartilage erosion. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging. Tibiofemoral cartilage erosion. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging. Anterior cruciate ligament injury. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging. Shahid Beheshti University of Medical Sciences Approved 2022-03-08 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Yaman St, Shahid Chamran Hwy Tehran Tehran Iran (Islamic Republic of)