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Recruiting NCT07727161

3D Printing in Preoperative Planning in Thoracic and Lumbar Spine Trauma

No phase Interventional Spine Trauma (Thoracic and Lumbar)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spine stabilization using CT planning, Spine stabilization using 3D-printed model planning.
Who it may be relevant to
Registry conditions: Spine Trauma (Thoracic and Lumbar). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impact of 3D Printed Models on Preoperative Planing in Thoracic and Lumbar Spine Trauma

Overview

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

  • Procedure Spine stabilization using CT planning
    Spine stabilization using CT planning
  • Procedure Spine stabilization using 3D-printed model planning
    Spine stabilization using 3D-printed model planning

Primary outcome measures

  • Blood Loss [Time frame: Peroperative (during surgery)]
Secondary outcome measures (3)
  • Surgical duration [Time frame: Peroperative (during surgery)]
  • Pedicle screw placement accuracy [Time frame: The parameter will be measured once on the first postoperative day]
  • 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.]

Eligibility criteria

Inclusion criteria

  • Single vertebra AO A2-A4 thoracic or lumbar spine fracture indicated for spine fixation.

Exclusion criteria

  • Neurological impairment caused by the fracture.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Masaryk hospital in Usti nad Labem — Ústí nad Labem

Identifiers

NCT: NCT07727161 · 3DPRINTSPINETRA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗