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IRCT20230820059200N1 IRCT 2023-10-03 Tehran University of Medical Sciences Shoulder arthrocentesis in two Methods with and without landmarks Evaluation of the Success rate of Shoulder Arthrocentesis & Injection methods by Orthopedic surgery residents With/without landmarks 2024-02-20 anticipated 10 Complete https://irct.ir/trial/72599 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Diagnostic, Randomization description: This study will be conducted as a cross-over trial in 1402 in Imam Khomeini Hospital of Tehran University of Medical Sciences and in the orthopedic department of this hospital. The study design process will be based on CONSORT guidelines. Study participants will perform shoulder arthrocentesis a total of 3 times: 1 time without landmarks, 1 time with landmarks and without traction, and 1 time with landmarks and with traction.The order of interventions in individuals will be determined in a simple random manner. At first, the necessary training regarding the anatomy of the shoulder joint and how to perform shoulder arthrocentesis with and without landmarks and, in the case of landmarks, with and without traction, will be given to the assistants by the orthopedic professor. The procedure will be performed by the "senior" resident of the group. It will be done under the supervision of the relevant teacher. Then 10 participants in the study will be randomly assigned to one of the following 6 groups and a maximum of two people will be placed in each group.Group 1: without landmark - with landmark with traction - with landmark without traction Group 2: without landmark - with landmark without traction - with landmark with traction Group 3: with landmark without traction - without landmark - with landmark with traction Group 4: with landmark without traction - with landmark with traction - without landmark Group 5: with landmark with traction - without landmark - with landmark without traction Group 6: with landmark with traction - with landmark without traction - without landmark For randomization, 1:1:1:1:1:1 blocks will be used and no more than two people will be placed in any of the groups. The process of randomization will be done by a person outside the research, and the researcher and assistants participating in the research will not be aware of the process. This is for Allocation Concealment, so that there is no intervention in terms of allocation of interventions by the research team, Blinding description: The researchers and the statistical analyst will not be aware of the intervention and the interventions will be defined as A, B, and C by a person outside the research for the researchers and the team of researchers from the assigned order and also the definition of the codes until after the implementation. Research will not be informed. In this way, the study will be done in a double-blind manner. N/A Evaluation of the success rate of shoulder arthrocentesis & injection methods by orthopedic surgery residents with/without landmarks. Intervention 1: First intervention :Insertion of the angiocath needle only once without drawing an anatomical landmark and in the condition that the hand is not in traction. Intervention 2: Second Intervention: assistant on the same patient as the first intervention; will perform the second intervention: the second intervention: entering only one time of the angiocath needle based on drawing the anatomical landmarks and while the patient's hand is not in traction. Intervention 3: Third Intervention: assistant on the same patient as the first intervention; He will perform the third intervention: The third intervention: the insertion of only one time of the angiocath needle based on the drawing of anatomical landmarks and while the patient's hand is in traction. 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 The release of more information will happen after the end of the study based on a specific plan that is not yet clear
public Seyyed Hosein Jahanbakhsh
No 35, Barati avenue, Ayat avenue, Nobovat square, Narmak
تهران Iran (Islamic Republic of) 1648819813 +98 21 7790 0924 dr.s.h.jahanbakhsh@gmail.com Tehran University of Medical Sciences scientific Mohammad Reza Guity
Imam khomeini hospital,keshavarz ave,Tehran town
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ 00982161190 Imamhospital@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) The patient's age is between 18 and 70 years old Diagnosis requiring arthroscopic surgery of the shoulder, such as rotator cuff tears, labrum repair, etc. Consent to participate in the study 18 years 70 years Both Existence of anatomic abnormality in pre-surgery imaging Previous arthroscopy in which the previous incision has remained Early detection Early detection Early detection First intervention :Insertion of the angiocath needle only once without drawing an anatomical landmark and in the condition that the hand is not in traction Second Intervention: assistant on the same patient as the first intervention; will perform the second intervention: the second intervention: entering only one time of the angiocath needle based on drawing the anatomical landmarks and while the patient's hand is not in traction Third Intervention: assistant on the same patient as the first intervention; He will perform the third intervention: The third intervention: the insertion of only one time of the angiocath needle based on the drawing of anatomical landmarks and while the patient's hand is in traction. Success rate of orthopedic assistants in performing shoulder arthrocentesis. Timepoint: The time period of the variable measurement is during the same day during the arthroscopic surgery. Method of measurement: After the complete arthrocentesis, the entry of the needle into the joint space will be evaluated by the arthroscope, and the assistant's performance will be graded from 0 to 2 by the professor:0 (not entering the shoulder joint)1 (entering the shoulder joint through the rotator cuff or biceps)2 (Entry through rotator interval)-In other words, the assistant's success in entering the Angiocath into the shoulder joint space will be checked with an arthroscope and scoring will be done as described above. Duration of arthrocentesis. Timepoint: The time period of the variable measurement is during the same day during the arthroscopic surgery. Method of measurement: At the same time as the landmark is drawn, the time is measured with a stopwatch and ends after the needle enters the skin, and the procedure time is measured in seconds. The ease of performing the procedure according to the assistant based on the Likert scale. Timepoint: The time period of the variable measurement is during the same day during the arthroscopic surgery. Method of measurement: The ease of performing the procedure is given a score by the resident who performed the procedure based on a Likert scale from 1 (least ease) to 10 (maximum ease). Tehran University of Medical Sciences Approved 2023-06-20 Research Ethics Committee of Imam Khomeini Hospital Complex - Tehran University of Medical Sciences No 35, Barati avenue, Ayat avenue, Nobovat square, Narmak Tehran Tehran Iran (Islamic Republic of)