Masaryk hospital in Usti nad Labem
Ústí nad Labem, Czechia
Location status: Recruiting
Recruiting
NCT Number: NCT07727161
3D Printing in Preoperative Planning in Thoracic and Lumbar Spine Trauma
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.
Recruiting
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Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Single vertebra AO A2-A4 thoracic or lumbar spine fracture indicated for spine fixation.
Exclusion criteria
- Neurological impairment caused by the fracture.
Treatment and study plan
Spine stabilization using CT planning
ProcedureSpine stabilization using CT planning
Spine stabilization using 3D-printed model planning
ProcedureSpine stabilization using 3D-printed model planning
Primary outcomes
-
Blood Loss
Time frame: 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 outcomes
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Surgical duration
Time frame: 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.
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Pedicle screw placement accuracy
Time frame: 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)
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Incision length
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Other
Registry information
Official study title
Impact of 3D Printed Models on Preoperative Planing in Thoracic and Lumbar Spine Trauma
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 27, 2026
- Registry last updated
- Jul 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.