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IRCT20230117057145N1 IRCT 2023-02-26 Karaj University of Medical Sciences The effect of lesser trochanter fixation on hip flexion strength The effect of lesser trochanter fixation on hip flexion strength in patients with intertrochantric fx of femur in Karaj Madani hospital 2023-02-20 anticipated 52 Complete https://irct.ir/trial/68079 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients with the same type of fracture are divided into two groups. In the first or control group, routine and gold standard treatment of intertrochanteric fracture is performed. In the intervention group, in addition to routine and gold standard fracture treatment, fixation of the lesser trochanter of the femur is also done with the help of wire. is done and the purpose of the study is to investigate the effect of fixation on hip flexion strength, Randomization description: Randomization among patients with simultaneous intertrochanteric fracture of the femur bone and separation of the lesser trochanter is a simple randomization method, the randomization unit is individual and using a table of random numbers, Blinding description: Examination of muscle strength by only one orthopedic surgeon (Dr. Mohammad Sajjad Mir Hosseini) who is the master of the project It is carried out and the examiner is not aware of which group the examinee belongs to. Also the patients themselves are not aware of which group they are in (double blind). N/A intertrochanteric fx of femur. Intervention 1: Intervention group: patients with intertrochanteric fracture of the femur who simultaneously have separation of the lesser trochanter. In these patients, in addition to the surgical treatment of intertrochanteric fracture (using common methods such as using DHS plate or cephalomedullary nail, etc.), their femoral lesser trochanter is also fixed with the help of wire. To perform the intervention (fixation of the lesser trochanter), no other tool is needed except for the wire and its guide (wire passer). Intervention 2: Control group: patients with simultaneous intertrochanteric fracture and separation of the lesser trochanter of the femur, who are treated commonly and routinely, but fixation of the lesser trochanter is not done in them. Yes - There is a plan to make this available What will be shared: All potential data can be shared after de-identifying individuals. When: The access period starts 6 months after the results are published. To whom: Only for researchers working in academic and scientific institutions Conditions: The use of documents for research and scientific work is allowed. Where to obtain: Applicants should contact the following email to use and receive documents: hamiso1988@gmail.com How to obtain: In a period of less than a week, the applicants for receiving the documents who contacted by e-mail will be answered and the documents will be provided to them. Comments:
public Hamid Sohrabian
AbooAliSina ave, Molana blvd
Karaj Iran (Islamic Republic of) 3143653688 +98 26 3444 3284 hamiso1988@gmail.com Karaj University of Medical Sciences scientific Hamid Sohrabian
AbooAliSina ave, Molana blvd
Karaj Iran (Islamic Republic of) 3143653688 +98 26 3444 3284 hamiso1988@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) patients with intertrochantric fx of femur and lesser trochantric fx age over 18 years 18 years no limit Both Contraindications for surgery The presence of previous diseases that affect the flexion power of the limb and interfere with the examination process (such as neuromuscular diseases, stroke, limb paralysis, etc.) The patient's lack of consent to participate in the trial S72.1 Pertrochanteric fracture Treatment - Surgery Treatment - Surgery Intervention group: patients with intertrochanteric fracture of the femur who simultaneously have separation of the lesser trochanter. In these patients, in addition to the surgical treatment of intertrochanteric fracture (using common methods such as using DHS plate or cephalomedullary nail, etc.), their femoral lesser trochanter is also fixed with the help of wire. To perform the intervention (fixation of the lesser trochanter), no other tool is needed except for the wire and its guide (wire passer). Control group: patients with simultaneous intertrochanteric fracture and separation of the lesser trochanter of the femur, who are treated commonly and routinely, but fixation of the lesser trochanter is not done in them. Flexion strength in patients with femoral intertrochanteric fracture. Timepoint: Measuring hip flexion strength at intervals of 6 weeks, 12 weeks, 24 weeks (6 months). Method of measurement: manual muscle testing (from zero fifth to five fifth). Karaj University of Medical Sciences Approved 2022-12-03 Ethics Committee of Alborz University of Medical Sciences Taleghani Square, North Taleghani Blvd, Alborz University of Medical Sciences karaj Alborz Iran (Islamic Republic of)