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IRCT20190810044492N2 IRCT 2023-07-31 Arak University of Medical Sciences Comparison of the effect of proximal femoral nailing (PFN) and dynamic hip screwing (DHS) in patients with intertrochanteric fractures. Comparison of the effect of proximal femoral nailing (PFN) and dynamic hip screwing (DHS) on mortality and Harris hip score of patients with intertrochanteric fracture. 2023-08-23 anticipated 206 Complete https://irct.ir/trial/70044 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method will be used. The randomization unit is the person. And they are divided into two groups based on the block randomization method in formats 4 and 8. For better randomization, web-based software will be used to prepare a randomization list, which creates random permutations for both types of treatment in each block. And due to the change of permutations in each block, concealment is also observed and during the implementation of the study, the predictability of the treatment for each patient is reduced by the researcher. The site used for random permutation block method: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Due to the double-blindness of the study, the data collector knows about the groupings, but the patients and the analyst do not know about the groupings. Informed consent is obtained from the patient that one of the proximal femoral nailing (PFN) and dynamic hip screwing (DHS) surgical procedures will be performed, but the patient will not know the type of surgical technique. The analyst is also a statistician who is outside the intervention process. N/A Intertrochanteric Fracture. Intervention 1: Intervention group1: One group will undergo PFN (proximal femoral nailing)surgery. In this method, by opening the entrance of the canal in the central part, the fracture is manipulated and the guide is inserted from the center of the canal into the fractured part. The fracture is kept in place. Intervention 2: Intervention group2: The second group is operated with DHS(versus dynamic hip screw ). In this method, after opening the operation site on the DHS bed through a lateral incision, the location of the fracture is determined, and then positioning is done using appropriate traction and maneuvers, and after ensuring its control with radiography, the DHS is placed in the operating room. 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 Still undecided - no release schedule yet
public Mohamad reza Bozorgmanesh
Valiasr Hospital
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3605 mhmmdrz_bzrgmnsh@yahoo.com Arak University of Medical Sciences scientific Mohamadreza Bozorgmanesh
Valiasr Hospital
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3605 mhmmdrz_bzrgmnsh@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Introcentric fracture Age 50 years Both genders Fracture duration less than 2 weeks 50 years no limit Both Lack of willingness to participate History of multiple fractures History of pathological fracture History of underlying bone disease S72.14 Intertrochanteric fracture of femur Treatment - Surgery Treatment - Surgery Intervention group1: One group will undergo PFN (proximal femoral nailing)surgery. In this method, by opening the entrance of the canal in the central part, the fracture is manipulated and the guide is inserted from the center of the canal into the fractured part. The fracture is kept in place. Intervention group2: The second group is operated with DHS(versus dynamic hip screw ). In this method, after opening the operation site on the DHS bed through a lateral incision, the location of the fracture is determined, and then positioning is done using appropriate traction and maneuvers, and after ensuring its control with radiography, the DHS is placed in the operating room. Mortality. Timepoint: 1, 3 and 6 months after surgery. Method of measurement: Follow up. Harris hip score assessment (HHS). Timepoint: 1, 3 and 6 months after surgery. Method of measurement: Demographic characteristics checklist and Harriss hip score (HHHS). HHS is a scoring index of the hip joint that has 100 points, and the higher the score, the more successful the surgery is, and it consists of four subscales: pain (44 points), Function (47 points), deformity (4 points) and range of motion (5 points).Pain range measures the intensity of pain, its effect on activities and the need for pain medication. Arak University of Medical Sciences Approved 2023-02-01 Ethics committee of Arak University of Medical Sciences Basij Ave, Chamran Blvd, Arak Town Arak Markazi Iran (Islamic Republic of)