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IRCT20230518058225N11 IRCT 2025-04-22 Iran University of Medical Sciences short term results of lateral extra articular tenodesis of the anterolateral ligament by harvesting from the hamstring tendon with modified lemaire method using the ITB fascia with out passing the graft under the lateral collateral ligament compared with classic methode in patients who underwent simultaneous reconstruction of the anterior cruciate ligament short term results of lateral extra articular tenodesis of the anterolateral ligament by harvesting from the hamstring tendon with modified lemaire method using the ITB fascia with out passing the graft under the lateral collateral ligament compared with classic methode in patients who underwent simultaneous reconstruction of the anterior cruciate ligament 2025-05-10 anticipated 100 Complete https://irct.ir/trial/81881 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into 2 groups. The randomization tool will randomize the table of numbers. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 10 blocks will be formed and in each block 5 people from intervention group and 5 people will be placed in the control group. A total of 10 blocks will be considered to reach the sample size. Blocks contain numbers, numbers represent study groups. Their order will be determined by the statistician from the beginning. In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. became. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: Patients will be aware that they will be randomly assigned to one of the two study groups, but will not know which method will be provided in that group. Patients will be assigned to one of two groups using a random number table. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the information based on groups 1 and 2 and will not know the type of treatment in the groups and will be kept blind. N/A Anterior cruciate ligament tear of the knee. Intervention 1: Intervention group 1: The reconstruction method of the anterior lateral ligament of the knee will be the modified Limer method, in such a way that after creating the tibial and femoral canals, an autograft is inserted for ACL reconstruction. By accessing the ITB site and identifying the anatomical origin on the femur, a flap 8 cm long and 1 cm wide is separated from the proximal part and then, after creating a transfemoral tunnel in the aforementioned location, the free head of the ITB flap will be fixed with a screw without passing under the LCL, after passing through the canal, in about 40 degrees of knee flexion. Intervention 2: Intervention group 2: After performing ACL repair surgery, they will undergo ACL reconstruction using the classic Limer method. An 8 cm long and 1 cm wide flap is separated from the proximal part, and after creating a transfemoral tunnel at the aforementioned location, the free head of the ITB flap will be fixed with a screw by passing under the LCL, with the knee flexed at approximately 40 degrees. 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 completing the work and consulting with all the writers and executive agents, I will make a decision.
public Farhood Abroosh
Beh Afarin Ave, Vali Asr Sq
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1600 farhoodabroosh@gmail.com Iran University of Medical Sciences scientific Hamid Reza Yazdi
Beh Afarin Ave, Vali Asr Sq
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1600 dr.yazdi۸۸@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) All patients requiring simultaneous reconstruction of the anterior cruciate ligament and anterior lateral ligament of the knee. Age 18 to 45 years 18 years 45 years Both Patients with other or multiple ligament injuries Patients who have suffered re-trauma to the same knee Patients who underwent surgery with the allograft technique S83.7 Injury to multiple structures of knee Treatment - Other Treatment - Other Intervention group 1: The reconstruction method of the anterior lateral ligament of the knee will be the modified Limer method, in such a way that after creating the tibial and femoral canals, an autograft is inserted for ACL reconstruction. By accessing the ITB site and identifying the anatomical origin on the femur, a flap 8 cm long and 1 cm wide is separated from the proximal part and then, after creating a transfemoral tunnel in the aforementioned location, the free head of the ITB flap will be fixed with a screw without passing under the LCL, after passing through the canal, in about 40 degrees of knee flexion. Intervention group 2: After performing ACL repair surgery, they will undergo ACL reconstruction using the classic Limer method. An 8 cm long and 1 cm wide flap is separated from the proximal part, and after creating a transfemoral tunnel at the aforementioned location, the free head of the ITB flap will be fixed with a screw by passing under the LCL, with the knee flexed at approximately 40 degrees. Anterior Cruciate Ligament Rupture. Timepoint: Follow-up 14 days, 2 weeks, 6 weeks, 3 months and 6 months after surgery. Method of measurement: Physician's clinical examination and registration in the checklist. Iran University of Medical Sciences Approved 2025-02-09 Faculty of Medicine - Iran University of Medical Sciences (Research Ethics Committee) Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)