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

A randomized, single-blind, parallel-group clinical trial with two intervention groups on 56 patients. Random Allocation software was used for randomization.

Study location: Biomechanics Laboratory, Faculty of Rehabilitation, Babol University of Medical Sciences Single-blind study with blinding of data analyst Determining the thickness of different parts of the quadriceps muscle using an ultrasound device .

Inclusion criteria 1. Men with anterior cruciate ligament injury and confirmation of complete anterior cruciate ligament tear in MRI findings 2. Confirmation of complete anterior cruciate ligament tear by an orthopedic surgeon 3. Average age 18 to 38 years 4. Surgery candidate with hamstring or patellar tendon graft Exclusion criteria 1. History of myopathy 2. History of previous knee surgery 3. History of lumbar surgery 4. History of rheumatological diseases 5. Collateral ligament or posterior cruciate ligament injuries, grade III meniscal tear, or cartilage damage 6. Lower limb injuries at least 6 months before the study

Intervention Group 1: Men with ACL reconstruction with hamstring tendon graft Intervention Group 2: Men with ACL reconstruction with patellar tendon graft

Primary outcome: 1. Thickness of the vastus lateralis muscle of the affected limb 2. Thickness of the vastus medialis oblique muscle of the affected limb 3. Thickness of the vastus intermedius muscle of the affected limb 4. Thickness of the rectus femoris muscle of the affected limb Secondary outcome: 1. Thickness of the long head of the biceps femoris muscle of the affected limb

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.

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.