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IRCT20220803055610N2 IRCT 2023-05-31 Tehran University of Medical Sciences Investigating the Effect of Platelet-Rich Plasma in Arthroscopy PRP Investigating the Role of Platelet-Rich Plasma in Shoulder Rotator Cuff Repair With Arthroscopy 2023-06-22 anticipated 20 Complete https://irct.ir/trial/70103 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients referred to the orthopedic department with the diagnosis of rotator cuff tendon injuries, which are small and medium tears, are selected by an orthopedic specialist by MRI examination and examinations based on the VAS index and shoulder function. Then the relevant questionnaires are completed. Patients are divided into two groups according to the table of random numbers, the first group is injected with PRP during arthroscopic surgery and the second group is performed alone. In two groups, after 3 and 8 weeks and 3 and 6 months, the patients are examined by performing examinations and completing the questionnaire again. 2 Small and medium rotator cuff tears of the shoulder. Intervention 1: Intervention group: After confirming the diagnosis and referring to the orthopedic department, the patients are randomly divided into two groups. For one group, PRP injection was performed, in which the prepared prp is injected in the shoulder area during arthroscopic surgery, and the changes created during 6 months after the end of the injection are measured. In this group, 20 cc of venous blood is taken and the blood sample is separated from the platelet-rich plasma by the Selex centrifuge under the RCF protocol. After 8 weeks, all investigations, including the amount of pain, function, and ultrasound changes, are repeated and a comparison is made between the clinical and paraclinical symptoms of the patient before and after the intervention. Intervention 2: Control group: In the control group, only arthroscopic surgery is performed and PRP is not injected. Yes - There is a plan to make this available What will be shared: Data will be shared after de-identifying individuals on pain, range of motion, shoulder function, and tendon thickness. When: 12 months after the results are published To whom: For researchers and workers in academic centers Conditions: For use in research or essays Where to obtain: by e-mail or mobile and request on the research gate website How to obtain: It will be sent to the applicant by email 3 months after the request Comments:
public Nima Bagheri
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1690 nimab1360@gmail.com Tehran University of Medical Sciences scientific Nima Bagheri
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1690 nimab1360@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) age between 18 and 70 years old symptoms of rotator cuff tears MRI findings of minor to medium rotator cuff tears 20 years 70 years Both a history of shoulder surgery, achronic dislocation or pyogenic infection, or rotator cuffarthropathy with glenohumeral osteoarthritis a large ormassive tear (anteroposterior size > 30 mm) during surgery pregnant or lactating women rheumatoid arthritis gout blood diseases severe cardiovascular dis-eases infections immunodepression patients receiving anticoagulant therapy patients with haemoglobin values < 11 g/dl and platelet values < 150, 000/mm 3. M65-M68 Small and medium rotator cuff tears of the shoulder Treatment - Drugs Other Intervention group: After confirming the diagnosis and referring to the orthopedic department, the patients are randomly divided into two groups. For one group, PRP injection was performed, in which the prepared prp is injected in the shoulder area during arthroscopic surgery, and the changes created during 6 months after the end of the injection are measured. In this group, 20 cc of venous blood is taken and the blood sample is separated from the platelet-rich plasma by the Selex centrifuge under the RCF protocol. After 8 weeks, all investigations, including the amount of pain, function, and ultrasound changes, are repeated and a comparison is made between the clinical and paraclinical symptoms of the patient before and after the intervention. Control group: In the control group, only arthroscopic surgery is performed and PRP is not injected. Pain. Timepoint: Every 2 weeks to eight weeks. Method of measurement: VAS score. Range of motion. Timepoint: Every two weeks to three months. Method of measurement: Goniometer. Ultrasound Findings. Timepoint: At the beginning of the study and after 3 months. Method of measurement: Ultrasound probe. Tehran University of Medical Sciences Approved 2023-05-08 Ethics committee of Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran,Tehran Medical sciences,Tehran Tehran Tehran Iran (Islamic Republic of)