Case series of 16 patients with lower lumbar or lower thoracic traumatic injuries treated with pedicle screw fixation. Patients were divided into two groups (n≈8 per group). The control group underwent standard fluoroscopy-controlled pedicle screw fixation with conventional preoperative CT planning. The experimental group underwent identical fluoroscopy-controlled fixation with preoperative planning using a patient-specific 3D-printed model.
Single vertebra AO A2-A4 thoracic or lumbar spine fracture indicated for spine fixation.
Neurological impairment caused by the fracture.
Parallel
Spine stabilization using CT planning
Procedure/SurgerySpine stabilization using CT planning
Spine stabilization using 3D-printed model planning
Procedure/SurgerySpine stabilization using 3D-printed model planning
Blood Loss
The amount of blood lost during the surgical procedure, measured in mililitres (mL). This outcome measure has no fixed upper limit and can vary widely, typically between 10 and 1,000 mL.
Surgical duration
The operation time measured in minutes. This measure does not have a specific upper limit and can reach various values, typically between 30-90 minutes.
Pedicle screw placement accuracy
We will measure the accuracy of pedicle screw placement using the postoperative CT scan. Specifically, axial CT slices will be used to assess the positioning of the screw thread within the pedicle, i.e., its distance in millimeters from the cortical margins of the pedicle according to the Rampersaud classification: A: completely within pedicle B: cortical breach \< 2 mm (often considered clinically acceptable) C: cortical breach 2-4 mm D: cortical breach \> 4 mm (more likely clinically significant)
Incision length
Incision length measured with a standard ruler. This outcome measure does not have a physiological range and can vary individually, typically 10-15 centimeters in bisegmental spine fixation.
Click on the lead sponsor to view all of their trials.
