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IRCT20231212060345N1 IRCT 2024-02-04 Shahid Beheshti University of Medical Sciences The effect of vascular stromal cells and platelet-rich plasma in the treatment of osteochondral lesions of the talus Therapeutic impact of Adipose-derived Stromal Vascular Fraction And Platelet-rich plasma on non-operative treatment of osteochondral lesions of the talus: A Randomized Controlled Trial 2024-01-05 anticipated 40 Complete https://irct.ir/trial/74340 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple, the randomization is individual, there is no stratified randomization, randomization with the NIH site tool, and the final Excel is prepared for randomization. Is. After entering the study according to the conditions mainly mentioned above, it is determined what intervention is performed for each patient based on a predetermined chain in Excel. For example, row 1 T is equivalent to the intervention group or row 2 C is equivalent to the control group. The patients are chained according to the order of referral, the first patient in the first row, the second patient in the second row, and so on. N/A talus osteochondral lesions- talus osteochondritis dissecans. Intervention 1: Intervention group: intra-articular injection of vascular stromal cells taken from fat, necessary equipment, svf extraction kit-syringe, SVF preparation: about 100 mL of adipose tissue is taken sterilely through liposuction of the abdomen. The obtained fat will be emulsified by passing through 2.4 mm, 1.2 mm filters and finally a 400 and 600 micrometer filter (25-30 passes). In order to separate free fatty acids, these nanofats are centrifuged (for 2 minutes at 1200 rpm) and the separated fatty acids will be discarded. The number of cells in the remaining substance will be counted under the microscope. The obtained nanofat is prepared for injection into the joint. The injection volume is 4-5 cc. The quantity and viability of the cells is done through direct observation under the neobar slide. After the injection, the patient must not apply weight for 24 hours The leg should be restrained (walk with a cane) and only paracetamol is allowed to be used for pain control. After a week, the patients will be contacted and questions will be asked about possible side effects. Intervention 2: Control group: Intervention group: intra-articular injection of platelet-rich plasma taken from peripheral blood, necessary equipment for PRP extraction kit-syringe, first blood is taken from a peripheral vein, then PRP is extracted from it with a centrifuge and injected for one time after injecting the patient until For 24 hours, he must refrain from putting weight on his leg (walk with a cane) and to control pain, only paracetamol is allowed to be used. After one week, patients will be contacted and questions will be asked about possible side effects. 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 Agree with the study team
public Sina Hajiaghajani
No 9 , Abdollahi ally, Darabad square , Poorebtehaj street, Ajoodanieh street, Aghdasieh
Tehran Iran (Islamic Republic of) 1956854733 +98 21 2610 6712 sinaaghajani1379@gmail.com Shahid Beheshti University of Medical Sciences scientific Sina Hajiaghajani
No 9 , Abdollahi ally, Darabad square , Poorebtehaj street, Ajoodanieh street, Aghdasieh
Tehran Iran (Islamic Republic of) 1956854733 +98 21 2610 6712 sinaaghajani1379@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The symptoms have been continuous for at least 3 months and have not responded to conservative treatment age 18-70 years Patients with grade I, II Bernadet and Harry classification lesions CT SCAN and MRI confirm the diagnosis and no other pathology is involved The patient has the ability to understand the explanations and registers her verbal and written wishes in the informed consent form 18 years 70 years Both presence of inflammatory arthritis such as rheumatoid arthritis, other systemic diseases such as diabetes and systemic inflammatory diseases; Systemic infection History of cardiovascular disease such as previous stroke or heart failure or coagulation problem such as disturbed PT, PTT, INR Any surgery or intra-articular injection Drug users or alcoholics Pregnancy or breastfeeding Severe weight loss in such a way that liposuction is not possible. Abdominal hernia The presence of loose bodies, osteoarthritic changes, impingement spurs, or other pathology M93.27 Osteochondritis dissecans of ankle and joints of foot Treatment - Other Treatment - Other Intervention group: intra-articular injection of vascular stromal cells taken from fat, necessary equipment, svf extraction kit-syringe, SVF preparation: about 100 mL of adipose tissue is taken sterilely through liposuction of the abdomen. The obtained fat will be emulsified by passing through 2.4 mm, 1.2 mm filters and finally a 400 and 600 micrometer filter (25-30 passes). In order to separate free fatty acids, these nanofats are centrifuged (for 2 minutes at 1200 rpm) and the separated fatty acids will be discarded. The number of cells in the remaining substance will be counted under the microscope. The obtained nanofat is prepared for injection into the joint. The injection volume is 4-5 cc. The quantity and viability of the cells is done through direct observation under the neobar slide. After the injection, the patient must not apply weight for 24 hours The leg should be restrained (walk with a cane) and only paracetamol is allowed to be used for pain control. After a week, the patients will be contacted and questions will be asked about possible side effects. Control group: Intervention group: intra-articular injection of platelet-rich plasma taken from peripheral blood, necessary equipment for PRP extraction kit-syringe, first blood is taken from a peripheral vein, then PRP is extracted from it with a centrifuge and injected for one time after injecting the patient until For 24 hours, he must refrain from putting weight on his leg (walk with a cane) and to control pain, only paracetamol is allowed to be used. After one week, patients will be contacted and questions will be asked about possible side effects. Diameter of Lesion. Timepoint: before entering the study - six months later. Method of measurement: CT scan. Function of ankle. Timepoint: before entering the study - one month later - three months later - six months later. Method of measurement: American Orthopedic Foot and Ankle Society questionnaire. Pain. Timepoint: before entering the study - one month later - three months later - six months later. Method of measurement: visual analog scale. Osteoarthritis changes. Timepoint: before entering the study - one month later - three months later - six months later. Method of measurement: Ankle osteoarthritis scale questionnaire. Lesion grade. Timepoint: before entering the study - six months later. Method of measurement: CT scan - Berndet and harty classification. Shahid Beheshti University of Medical Sciences Approved 2023-11-01 Working Group/Committee of Research Ethics of Dermatology Research Center - Shahid Beheshti Universi Tehran - Quds town (west) - between South Flamak and Zarafshan, Simai Iran St. - Central Headquarters of Ministry of Health, Treatment and Medical Education, Block A, 13th floor tehran Tehran Iran (Islamic Republic of)