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IRCT20221113056482N1 IRCT 2023-02-21 Tabriz University of Medical Sciences Comparison of internal fixation results of intracapsular fracture of the femoral neck by two methods of cannula screws and concellous screws in osteoporotic patients Comparison of internal fixation results of intracapsular fracture of the femoral neck by two methods of cannula screws and concellous screws in osteoporotic patients 2022-12-22 anticipated 40 Complete https://irct.ir/trial/66993 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the "Random Allocation Law" method was used so that the numbers for randomization were written on cards in order. Even numbers were considered for the first group (internal fixation with three cannulated screws of 6.5 mm with the inverted triangle method) and odd numbers for the second group (internal fixation with three cancellous screws of 6.5 mm with the inverted triangle method). In this method, the number of people assigned to each group will be balanced at the end of the study. 2 Femoral neck fracture in osteoprotic patients. Intervention 1: Intervention group 1: internal fixation with three 6.5 mm cannulated screws with inverted triangle method (standard treatment). After being fixed in the supine position in a special orthopedic bed, they receive spinal anesthesia or general anesthesia and undergo closed reduction under c-arm control. Then, with the standard lateral approach, the placement of the screws is determined with Kirschner rods. Intervention 2: Intervention group: Internal fixation with three 6.5 mm cancellous screws using the inverted triangle method. Yes - There is a plan to make this available What will be shared: After making people unidentifiable, the results will be published in the form of dissertations and articles When: Access starts After preparing the results To whom: All of the researchers Conditions: Examining and expanding the results Where to obtain: Shahab Mahdipour Email: shahab5mph@gmail.com How to obtain: Contact by email up to one month after the request Comments:
public Alireza Sadeghpour
Shohada Medical Research & Training Hospital, Golshahr street
Tabriz Iran (Islamic Republic of) 5167846171 +98 41 3389 3765 amir.valizadeh67@gmail.com Tabriz University of Medical Sciences scientific Alireza Sadeghpour
Shohada Medical Research & Training Hospital, Golshahr street
Tabriz Iran (Islamic Republic of) 5167846171 +98 41 3389 3765 alirezasadeghpuor17@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Men or women with no upper age limit Femoral neck fracture confirmed by radiography of the hip and femur, computed tomography, or magnetic resonance imaging (MRI) Operative treatment of fractures within 4 days of visiting the emergency room, or operation of non-displaced fractures within 7 days of visiting the emergency room. The patient was ambulatory before the fracture, although she may have used an aid such as a cane or walker Predictive medical optimization for hip surgery Provision of informed consent by the patient or designated legal representative Do not have any other major trauma such as another fracture, according to the supervisor's judgment 45 years no limit Both Patients not suitable for intracapsular fixation (ie, severe osteoarthritis, rheumatoid arthritis, or pathologic fracture). S72.0 Fracture of head and neck of femur Treatment - Surgery Treatment - Surgery Intervention group 1: internal fixation with three 6.5 mm cannulated screws with inverted triangle method (standard treatment). After being fixed in the supine position in a special orthopedic bed, they receive spinal anesthesia or general anesthesia and undergo closed reduction under c-arm control. Then, with the standard lateral approach, the placement of the screws is determined with Kirschner rods. Intervention group: Internal fixation with three 6.5 mm cancellous screws using the inverted triangle method. Fixation of intracapsular fracture of femoral neck. Timepoint: The patient is followed up in the clinic for two weeks, one month, three months, six months and annually for up to 3 years to record clinical and radiological results. Method of measurement: After the operation, the clinical results will be evaluated in the form of scoring in each visit. Welding will be checked with graphs in face view with 15 degrees of internal rotation of the legs and profile view. The creation of trabeculae from between the fracture line will be considered as welding. Non-union is considered as no formation of said trabeculae, redistribution or progressive. Full weighting will be allowed by ensuring welding in the graph. If re-surgery is required, follow-up will be done before re-surgery. Tabriz University of Medical Sciences Approved 2022-08-29 Ethics committee of Tabriz University of Medical Sciences Golgasht Tabriz East Azarbaijan Iran (Islamic Republic of)