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

July 20, 2026 updated by: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Impact of 3D Printed Models on Preoperative Planing 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Ústí nad Labem, Czechia
        • Recruiting
        • Masaryk hospital in Usti nad Labem
        • Contact:
          • Masaryk Hospital, Ústí Nad Labem, Ustecky Kraj 40113
          • Phone Number: +420 477 111 111
          • Email: sekretariat.ul@kzcr.eu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurological impairment caused by the fracture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spine stabilization with conventional preoperative CT-scan-planned pedicle screw fixation
A standard bisegmental posterior spine stabilization through a posterior midline approach with conventional preoperative CT-scan planning and peroperative C-arm radiographic guidance.
Procedure: Spine stabilization using CT planning
Spine stabilization using CT planning
Active Comparator: Spine stabilization with 3D-printed model-planned pedicle screw fixation
A standard bisegmental posterior spine stabilization through a posterior midline approach with preoperative planning using 3D-printed spine models and peroperative C-arm radiographic guidance.
Procedure: Spine stabilization using 3D-printed model planning
Spine stabilization using 3D-printed model planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Peroperative (during surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Peroperative (during surgery)
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)
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

July 9, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 3DPRINTSPINETRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe