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IRCT20230716058805N1 IRCT 2023-07-31 Artesh University of Medical Sciences Comparison of different methods of knee anterior cruciate ligament surgery Comparison of clinical results using hamstring versus quadriceps tendon graft and versus bone-patella tendon in anterior cruciate ligament reconstruction , a randomized clinical trial 2021-03-21 anticipated 63 Complete https://irct.ir/trial/71351 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly divided into three groups 1:1:1. Each patient who enters the study will be assigned a unique number. Using the method of balanced consecutive blocks (Permuted Balanced Block Randomization) and the command of random numbers in Microsoft Office Excel 365 software, the table of random assignment of each patient to one of three different surgical groups is prepared. Patients based on their unique number specified in the patient report form; They are divided into one of three groups. Concealment: The random numbers generated for assigning referring patients to different treatment groups will be hidden from the opinion and information of the project manager and collaborators until the end of the study, and will be revealed after data analysis. In order to hide the sequence of generated random numbers, they are assigned to different treatments through pre-determined codes, and the clinical colleagues do not have any knowledge of the defined assigned code when prescribing. The orthopedic surgeon will be informed of the patient's assigned group on the day of the operation. N/A anterior cruciate ligament tear. Intervention 1: Intervention group: First: 21 patients undergo anterior cruciate ligament surgery with patellar tendon. Intervention 2: Intervention group: The second group: 21 patients undergo hamstring surgery. Intervention 3: Intervention group: Third: 21 patients undergo anterior cruciate ligament surgery with quadriceps tendon. 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 further information
public Nima hoseinizare
No. 7, 5th West AVE, Morvarid ST, Saadat abad
Tehran Iran (Islamic Republic of) 1998745363 +98 21 2236 9615 nimazr70@gmail.com Artesh University of Medical Sciences scientific Nima Hoseinizare
No.7, 5th West AVE, Morvarid ST, Saadat abad
Tehran Iran (Islamic Republic of) 1998745363 +98 21 2236 9615 nimazr70@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) 1. Patients who undergo anterior cruciate ligament resection surgery 2. Over 18 years of age 3. BMI ≤ 35 Willingness and ability to prepare a written consent form 4. Willingness and ability to perform subjective evaluations and have the ability to understand written questionnaires 5, Suffering from rupture 6. Present May he not take any medicine that changes knee symptoms throughout the study until the end. 7. Willingness and ability to agree to the conditions related to the study and procedures and visits. no limit no limit Male 1. Injuries associated with ACL such as torn meniscus or posterior cruciate ligament 2. Follow-up of patients under 12 months 3, Patients who had complications such as thrombosis or embolism during or immediately after surgery 4, Patients who do not come for follow-up 5, Diseases High-risk medical condition such as kidney, liver and heart failure 6, History of addiction 7, A history of any surgery related to the knee 8. Contraindications for imaging and MRI 9. Mental disorders 10. Progressive neurological disorders 11. Having pain in another place that causes disturbance in the assessment of shoulder pain Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: First: 21 patients undergo anterior cruciate ligament surgery with patellar tendon. Intervention group: The second group: 21 patients undergo hamstring surgery. Intervention group: Third: 21 patients undergo anterior cruciate ligament surgery with quadriceps tendon. Army employees and soldiers who have ruptured the anterior cruciate ligament, their demographic information is obtained by interviewing and completing a questionnaire, then after randomization, random allocation, and concealment, they are randomly divided into 3 groups, and each group undergoes a type of surgery by They are placed by a surgeon and with a fixation method, and immediately after the operation, as well as the follow-up periods of 3, 6, and 12 months, they are examined and asked about function (Lee Scholem questionnaire), pain level, and clinical examinations of ligament laxity, and at the end, the patient information is provided by the program. SPSS is subjected to statistical analysis. Timepoint: Immediately after the operation, as well as the follow-up periods of 3, 6, and 12 months. Method of measurement: They are examined and questioned in terms of function (Lee Scholem questionnaire), pain level and clinical examinations for ligament laxity. Artesh University of Medical Sciences Approved 2022-08-21 Ethics Committee of Army Medical Sciences University NO. 7,West 5th AVE, Morvarid BLVD, Saadat abad Tehran Tehran Iran (Islamic Republic of)