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IRCT20210520051351N2 IRCT 2022-04-16 Vice Chancellor for Research, Iran University of Medical Sciences Comparison of anterior cruciate ligament vascularization after reconstruction with maintaining distal tibia insertion and application of tibial screw Comparison of Anterior Cruciate Ligament Vascularization after Reconstruction with Hamstring Autograft in two Methods of Maintaining Distal Tibial Insertion with and Without Fixation with Absorbable Interference Screw, based on the Findings of Dynamic Contrast Enhanced MRI, a Double Blind Randomized Clinical Trial Study 2022-04-15 anticipated 40 Complete https://irct.ir/trial/62949 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method in the present study: For random assignment of patients to study groups, each eligible patient is assigned a number in the order of inclusion in the study. Randomization unit: will be individual Layers of randomization: Using stratified randomization Patients are randomly placed in different groups and random blocks are used for balance in groups. The samples are classified according to the center of the class and then in each class with the help of software to generate a random sequence. Randomization tool: Random numbers according to the number of patients by Excel software The method of constructing a random sequence is selected one by one Explanation of allocation concealment: Patients do not know the type of surgery and the person performing the analysis does not know the type of intervention, Blinding description: At the time of obtaining informed consent, patients are explained in an understandable language that they will undergo one or two surgeries in one of two ways. Then a list of random numbers according to the number of patients is prepared by Excel software. This list is then divided into two parts (groups 1 and 2). Each patient will be included in the relevant group according to the number assigned to him / her upon arrival and the envelope with the patient group written on it will be delivered to the relevant doctor. Thus, the patient will not be aware of the type of intervention performed, while the physician will be aware of the type of surgical treatment adopted (double-blind). Random patients are operated on in one of two ways. There is no difference between the two methods in terms of preoperative and postoperative programs. There is no difference between the two methods in terms of pre- and postoperative interventions and the rate of complications. There is no difference between patients in terms of the appearance of organs after surgery. There is no difference in preoperative and postoperative rehabilitation between the two groups. The surgeon is aware of the type of surgery, but in the postoperative period he treats the patients in the same way. The surgeon is aware of the type of surgery, but he treats the patients in the same way in both groups. N/A Anterior cruciate ligament tear. Intervention 1: Intervention group: Patients with ACL tear who undergo ACL reconstruction surgery in a new way with complete preservation of the hamstring tendons from the distal and separation from the proximal. The hamstring tendons are preserved distally and detached from the proximal to the lower extremity on the same side, and are harvest while the distal attachment of the tendons is attached. It is then reconstructed arthroscopically. And the distal connection of the tendon is fixed with a removable screw. Intervention 2: Control group: Patients with ACL tear who undergo ACL reconstruction surgery in a new way with complete preservation of the hamstring tendons from the distal and separation from the proximal. The hamstring tendons are preserved distally and detached from the proximal to the lower extremity on the same side, and are harvest while the distal attachment of the tendons is attached. It is then reconstructed arthroscopically. And the distal connection of the tendon is not fixed with a removable screw. 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 After collecting the data, they are analyzed and written an article. If the journal wants the data, we will provide it to the journal with the patients' consent.
public Alireza Askari
Mojahedin-e-Islam Street
Tehran Iran (Islamic Republic of) 1157637131 +98 21 3354 2041 aaskari60@yahoo.com Iran University of Medical Sciences scientific Mehdi Mohammadpour
Mojahedin-e-Islam Street
Tehran Iran (Islamic Republic of) 1157637131 +98 21 3354 2041 mehdi.668491@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-50 years with ACL tear following trauma Patients with ACL tear that is both clinically and MRI-confirmed Provide written consent to enter the study 18 years 50 years Both ACL partial tear malalignment of varus or valgus ACL reconstruction with allograft Previous history of knee surgery History of sensitivity to contrast material S83.5 Sprain of cruciate ligament of knee Treatment - Surgery Treatment - Surgery Intervention group: Patients with ACL tear who undergo ACL reconstruction surgery in a new way with complete preservation of the hamstring tendons from the distal and separation from the proximal. The hamstring tendons are preserved distally and detached from the proximal to the lower extremity on the same side, and are harvest while the distal attachment of the tendons is attached. It is then reconstructed arthroscopically. And the distal connection of the tendon is fixed with a removable screw. Control group: Patients with ACL tear who undergo ACL reconstruction surgery in a new way with complete preservation of the hamstring tendons from the distal and separation from the proximal. The hamstring tendons are preserved distally and detached from the proximal to the lower extremity on the same side, and are harvest while the distal attachment of the tendons is attached. It is then reconstructed arthroscopically. And the distal connection of the tendon is not fixed with a removable screw. Anterior cruciate ligament vascularization rate reconstructed by preserving distal attachment with and without tibia screw. Timepoint: Measurements of vascularization were taken at 6 and 12 weeks after reconstruction. Method of measurement: With Gadolinium enhanced MRI. Womac and Tegner-lysholm form score. Timepoint: 6 and 12 weeks after reconstruction. Method of measurement: Womac and Tegner-lysholm form score. Vice Chancellor for Research, Iran University of Medical Sciences Approved 2022-03-11 Ethics committee of Iran University of Medical Sciences Mojahedin Islam St. Shafa Yahyaian Hospital تهران Tehran Iran (Islamic Republic of)