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IRCT20200802048270N1 IRCT 2021-11-12 Iran University of Medical Sciences observation of prevention of tibia tunneling Evaluation of the effectiveness of placing the proximal 1/3 anterior cruciate ligament stump in individuals with complete anterior cruciate ligament rupture in preventing an increase in tibial tunnel diameter: a randomized controlled clinical trial 2021-11-22 anticipated 30 Complete https://irct.ir/trial/50184 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random chain construction of two groups of 15 A (intervention group) and B (control group) using Excel software will be used. In a column of 15 letters A and 15 letters B and in the adjacent column with the Rand command, make 30 random numbers. Arrange both columns in random order from large to small. The sequence of letters A and B will be the random sequence used, Blinding description: Patients and researchers analyzing the results will be blind to the surgical procedure. N/A disruption of anterior cruciate ligament of knee. Intervention 1: Patients who during surgery, 1/3 of the proximal remnants of the anterior cruciate ligament (ACL) stump remain in the tibial canal. Intervention 2: Control group: Patients without proximal remnants of the anterior cruciate ligament (ACL) stump in the tibial canal. Yes - There is a plan to make this available What will be shared: Unidentifiable personal data of participants will be shared upon request upon completion of the study. The protocol of surgery and study will be provided to the researchers in the form of a report after the end of the study. Statistical analysis of the data of this study will be shared in the form of a report after the end of the study. Informed design consent form, study clinical reports and codes used in the analysis will be shared in the form of a report at the end of the study. Part of the data, such as information about the main outcome or the like, will be published collectively without identifying individuals in the form of an article. When: 6 months after printing the results To whom: researchers Conditions: Use to enhance knowledge and researchers without permission to manipulate documents Where to obtain: Firoozgar Hospital How to obtain: Send a written request and then review and if the request is approved, the documents will be delivered. (Maximum one month) Comments:
public Ahmad Azizi
Valiasr Square, Karim Khan Zand St., Beh Afarin St.Tehran
Tehran Iran (Islamic Republic of) 4871115937 +98 21 8214 1000 azizi3981@gmail.com Iran University of Medical Sciences scientific Hamidreza Yazdi
Valiasr Square, Karim Khan Zand St., Beh Afarin St, Tehran
Tehran Iran (Islamic Republic of) 4871115937 +98 21 8214 1000 dr.yazdi88@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 18 to 40 years old complete anterior cruciate ligament Consent to participate in the study 18 years 40 years Both history of previous surgery due to anterior cruciate ligament injury History of surgery on other lower limbs M23.61 Other spontaneous disruption of anterior cruciate ligament of knee Treatment - Surgery Treatment - Surgery Patients who during surgery, 1/3 of the proximal remnants of the anterior cruciate ligament (ACL) stump remain in the tibial canal. Control group: Patients without proximal remnants of the anterior cruciate ligament (ACL) stump in the tibial canal Tibial canal diameter change 1. Timepoint: The diameter of the tibial tunnel is measured during the operation and 12 months after the operation. Method of measurement: The diameter of the tibial tunnel is measured during surgery and 12 months after surgery using a CT scan by an orthopedic surgeon. Frequency of anterior sliding test negative. Timepoint: 12 months after surgery. Method of measurement: Clinical examinations. Frequency of negative pivot-shift test. Timepoint: 12 months after surgery. Method of measurement: Clinical examinations. Lysholm scale score. Timepoint: 12 months after surgery. Method of measurement: Lysholm scale questionnaire. Ikdc scale score. Timepoint: 12 months after surgery. Method of measurement: Ikdc scale questionnaire. Frequency of Lachman test negative. Timepoint: 12 months after surgery. Method of measurement: Clinical examinations. Iran University of Medical Sciences Approved 2021-03-06 Ethics committee of Iran University of Medical Sciences Tehran Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)