Condition 1: Diaphysis fracture of the long bones of the lower extremities (Femoral Shaft). Condition 2: Diaphysis fracture of the long bones of the lower extremities (Tibia). Fracture of shaft of femur Unspecified fracture of shaft of tibia
Conditions
Interventions
Intervention 1: Intervention group: There are patients who will have a distal femoral or tibial concave screw implantation using surgical navigation or fluoroscopy. In this method, the navigation syst
Sponsors
Tehran University of Medical Sciences
Parseh Intelligent Surgical Systems Co.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with diaphysis fractures of the long bones of the lower extremities (femoral shaft or tibia) who are candidates for intramedullary nails (IMN) implantation.
Exclusion criteria
Exclusion criteria: Patients with open femoral or tibial shaft fractures patients with small canal diameter patients with bone canal obstruction patients with a history of infection or active bone canal infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Screw insertion time. Timepoint: From the time of the start of the distal screw insertion until the end of it, during the operation. Method of measurement: Based on the time measured by the stopwatch.;Duration of operation. Timepoint: From the time of the first fluoroscopic image of the organ to the time of preparing the fluoroscopic image for the final check. Method of measurement: Based on the time measured by the stopwatch.;Radiation dose received. Timepoint: The amount of radiation received during the operation. Method of measurement: With the help of special radiology badges.;X-ray radiation time. Timepoint: The duration of taking pictures with the C arm in each of the imaging methods. Method of measurement: Using the device's own settings.;The number of repetitions of photography. Timepoint: The number of times of taking pictures with the arm in each of the imaging methods. Method of measurement: Using the device's own settings.;The number of times to drill. Timepoint: The number of times to drill to find the screw path. Method of measurement: The number of times the guide contour leaves, which is mentioned in the patient's file and recorded by the resident during the procedure.;Duration of operating room stay. Timepoint: The duration of the patient's presence in the operation room from the time of entry to the time of exit. Method of measurement: Based on the time measured by the stopwatch.;Setup time. Timepoint: The time required to set up the operation equipment. Method of measurement: Based on the time measured by the stopwatch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Checking the amount of union. Timepoint: In time intervals of 3, 6, 9 and 12 months after surgery. Method of measurement: Based on imaging data and the opinion of an orthopedic specialist.;Checking the alignment of screws by imaging. Timepoint: Checking the alignment of the distal screws with respect to the contour in the post-operative graph - the presence or absence of angulation and torsion. Method of measurement: Based on the opinion of an orthopedic and radiology specialist.;Duration of anesthesia. Timepoint: From the time of induction of anesthesia until the time of complete return of consciousness. Method of measurement: Based on the time measured by the stopwatch. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammad Hossein Nabian
Tehran University of Medical Sciences
Outcome results
None listed