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IRCT20221019056245N3 IRCT 2025-11-29 Babol University of Medical Sciences Assessment of quadriceps thickness in males following ACL reconstruction using hamstring vs. patellar tendon grafts Assessment of quadriceps thickness in males following ACL reconstruction using hamstring vs. patellar tendon grafts 2025-12-06 anticipated 56 Complete https://irct.ir/trial/87526 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: In this parallel randomized controlled trial, given that not all patients will enter the study at the same time and that the researchers cannot predict in advance which group each patient entering the study will belong to, the block randomization method will be used to assign each patient to one of the two groups. In order to conceal the random assignment, the codes generated by the software will be placed in opaque envelopes so that it is not clear which group the next person will be placed in. In this study, eligible participating patients will be randomly assigned to one of the two control and intervention groups in a 1:1 ratio in blocks of 4 according to the block randomization protocol (generated by Random Allocation Software), after receiving informed consent, in such a way that the researcher cannot predict which intervention group the next person will be placed in. The codes will be placed in opaque envelopes, and with each new person entering, the envelope will be opened and the person's belonging to the relevant group will be determined, Blinding description: In this type of intervention, the patients themselves cannot be blinded. However, the data analyst will be completely unaware of which group the patients belong to in order to measure the outcomes. However, blinding the evaluator will not be possible because the operated area is specific. N/A Anterior Cruciate ligament tear. Intervention 1: First Intervention group: Anterior cruciate ligament reconstruction with hamstring tendon graft. Intervention 2: Second Intervention group: Anterior cruciate ligament reconstruction with patellar tendon graft. 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 Khodabakhsh Javanshir
Babol University of Medical Sciences, Ganjafrooz St., Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 khodabakhshjavanshir@gmail.com Babol University of Medical Sciences scientific Khodabakhsh Javanshir
Babol University of Medical Sciences, Ganjafrooz St, Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 khodabakhshjavanshir@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Men with ACL injury and confirmed complete ACL tear on MRI findings Confirmation of complete ACL tear by orthopedic surgeon Candidate for surgery with hamstring graft or patellar tendon graft 18 years 38 years Male History of myopathy History of previous knee surgery History of lumbar surgery History of rheumatological diseases Collateral ligament or posterior cruciate ligament injuries, grade III meniscal tear, or cartilage injury Lower limb injuries at least 6 months before the study Treatment - Surgery Treatment - Surgery First Intervention group: Anterior cruciate ligament reconstruction with hamstring tendon graft Second Intervention group: Anterior cruciate ligament reconstruction with patellar tendon graft 1- Vastus lateralis thickness of affected side 2- Vastus medialis oblique thickness of affected side 3- Vastus intermedius thickness of affected side 4- Rectus femoris thickness of affected side. Timepoint: 48 hours before and one week after anterior cruciate ligament reconstruction surgery. Method of measurement: Ultrasonography device. Long head of Biceps Femoris thickness of affected side. Timepoint: 48 hours before and 1 week after anterior cruciate ligament reconstruction surgery. Method of measurement: Ultrasonography device. Babol University of Medical Sciences Approved 2025-10-05 Ethics committee of Babol University of Medical Sciences Ganj afrooz St. Babol Mazandaran Iran (Islamic Republic of)