Spine Trauma (Thoracic and Lumbar)
Conditions
Brief summary
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.
Interventions
PROCEDURESpine stabilization using CT planning
Spine stabilization using CT planning
PROCEDURESpine stabilization using 3D-printed model planning
Spine stabilization using 3D-printed model planning
Sponsors
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Single vertebra AO A2-A4 thoracic or lumbar spine fracture indicated for spine fixation.
Exclusion criteria
* Neurological impairment caused by the fracture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | Peroperative (during surgery) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical duration | Peroperative (during surgery) | 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 | The parameter will be measured once on the first postoperative day | 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 | This parameter will be assessed during the postoperative period, specifically on the day of suture removal, which is typically on day 10-14 after surgery. | 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. |
Countries
Czechia
Contacts
CONTACTMarek Zrzavecky, M.D.
Outcome results
None listed