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Evaluation of the effect of surgical guidance system in spine surgery

Evaluation of accuracy and cost-effectiveness of using surgical guidance system with the help of fluoroscopic images in placing pedicle screws in comparison with conventional methods

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210712051854N4
Enrollment
44
Registered
2022-11-05
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine surgeries.

Interventions

Intervention 1: Intervention group: There are patients who will have pedicle screw implantation using Surgical navigation or Fluoroscopy. Intervention 2: Control group: Includes patients in whom the p

Sponsors

Parseh Intelligent Surgical Systems Co.
Lead Sponsor
Tehran University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients should have spinal surgery and a pedicle screw implanted in the neck surface. Patients should have spinal surgery and a pedicle screw implanted in the chest surfaces. Patients should have spinal surgery and pedicle screw implantation in the lumbar surfaces. Patients should have spinal surgery and pedicle screw implantation at the sacral surfaces.

Exclusion criteria

Exclusion criteria: Dissatisfaction with participating in the study Age under 18 years

Design outcomes

Primary

MeasureTime 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.;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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Hossein Nabian

Tehran University of Medical Sciences

mh-nabian@sina.tums.ac.ir+98 21 8490 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026