]>
IRCT20230211057388N1 IRCT 2023-03-05 Esfahan University of Medical Sciences Non-union femoral shaft fractures Investigation and comparison of the treatment of non-union fractures of the femur by two methods of nail exchange and the use of bone grafting along with plate augmentation. 2023-02-20 anticipated 40 Complete https://irct.ir/trial/68517 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization will be done with the help of random number table. If the number is even, it will belong to the first group, and if it is odd, it will belong to the second group. N/A Femoral fracture non union. Intervention 1: Intervention group: intramedullary nailing. The intramedullary canal will be over-reamed several sizes, and a nail at least 1 mm (ranging from 1 to 3 mm) larger in diameter will be inserted. The average initial nail diameter. Intervention 2: Intervention group: plate augmentation. An augmentation plate with autogenous bone grafting will be performed after exposing the nonunion site using the lateral approach. Cortico-cancellous bone grafts from ipsilateral iliac crest will be harvested simultaneously by another surgical team. We will use dynamic compression plates (DCP) with eight holes. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Mohammad Shahsavan
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mohammad_shah69@res.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad shahsavan
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mohammad_shah69@res.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with transverse and oblique fractures (the fracture line with the axis of the femoral medulla has an angle of less than 45 degrees) femur treated with intra-medullary nail Diagnosis of non-union by orthopedic specialist 6 months after surgery A candidate for surgery to correct non-union Informed consent 18 years 60 years Both Underlying disease Infectious nonunion Re-fracture S72.3 Fracture of shaft of femur Treatment - Devices Treatment - Devices Intervention group: intramedullary nailing. The intramedullary canal will be over-reamed several sizes, and a nail at least 1 mm (ranging from 1 to 3 mm) larger in diameter will be inserted. The average initial nail diameter. Intervention group: plate augmentation. An augmentation plate with autogenous bone grafting will be performed after exposing the nonunion site using the lateral approach. Cortico-cancellous bone grafts from ipsilateral iliac crest will be harvested simultaneously by another surgical team. We will use dynamic compression plates (DCP) with eight holes Bony union. Timepoint: 3 and 6 months postoperatively. Method of measurement: Medical history, physical exam, radiography. Esfahan University of Medical Sciences Approved 2021-11-08 Ethics committee of isfahan university of medical science Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)