Spine Trauma (Thoracic and Lumbar)NCT07727161
3D Printing in Preoperative Planning in Thoracic and Lumbar Spine Trauma
A study testing Spine stabilization using CT planning and Spine stabilization using 3D-printed model planning in people with Spine Trauma (Thoracic and Lumbar), run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spine Trauma (Thoracic and Lumbar)
- What is being tested?
- Spine stabilization using CT planning and Spine stabilization using 3D-printed model planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Jul 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Single vertebra AO A2-A4 thoracic or lumbar spine fracture indicated for spine fixation.
Who cannot join
- Neurological impairment caused by the fracture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk hospital in Usti nad Labem
Ústí nad Labem
Masaryk Hospital, Ústí Nad Labem, Ustecky Kraj 40113, +420 477 111 111, sekretariat.ul@kzcr.eu
About this study
Official title: 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.
- Conditions
- Spine Trauma (Thoracic and Lumbar)
- Being tested
- Spine stabilization using CT planning, Spine stabilization using 3D-printed model planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine stabilization using CT planningProcedure or surgery
Spine stabilization using CT planning
Spine stabilization using 3D-printed model planningProcedure or surgery
Spine stabilization using 3D-printed model planning
| Study group | Role | What they receive |
|---|---|---|
| Spine stabilization with conventional preoperative CT-scan-planned pedicle screw fixation | Active comparator | A standard bisegmental posterior spine stabilization through a posterior midline approach with conventional preoperative CT-scan planning and peroperative C-arm radiographic guidance. Receives: Procedure: Spine stabilization using CT planning |
| Spine stabilization with 3D-printed model-planned pedicle screw fixation | Active comparator | 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. Receives: Procedure: Spine stabilization using 3D-printed model planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Peroperative (during surgery)
Secondary outcomes (3)
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.
Measured: Peroperative (during surgery)
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)
Measured: The parameter will be measured once on the first postoperative day
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start7 Jul 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine Trauma (Thoracic and Lumbar)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727161
- Sponsor's protocol ID
- 3DPRINTSPINETRA
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 3D Printed Models on Preoperative Planing in Thoracic and Lumbar Spine Trauma
- ClinicalTrials.gov ID
- NCT07727161
- Acronym / sponsor ID
- 3DPRINTSPINETRA
- Conditions
- Spine Trauma (Thoracic and Lumbar)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spine stabilization with conventional preoperative CT-scan-planned pedicle screw fixation | Active comparator | Procedure: Spine stabilization using CT planningA standard bisegmental posterior spine stabilization through a posterior midline approach with conventional preoperative CT-scan planning and peroperative C-arm radiographic guidance. |
| Spine stabilization with 3D-printed model-planned pedicle screw fixation | Active comparator | Procedure: Spine stabilization using 3D-printed model planningA standard bisegmental posterior spine stabilization through a posterior midline approach with preoperative planning using 3D-printed spine models and peroperative C-arm radiographic guidance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Single vertebra AO A2-A4 thoracic or lumbar spine fracture indicated for spine fixation.
Key exclusion criteria (1 listed)
- Neurological impairment caused by the fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine stabilization using CT planningSpine stabilization using CT planning | Procedure or surgery | Spine stabilization with conventional preoperative CT-scan-planned pedicle screw fixation |
| Spine stabilization using 3D-printed model planningSpine stabilization using 3D-printed model planning | Procedure or surgery | Spine stabilization with 3D-printed model-planned pedicle screw fixation |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spine stabilization using CT planning and Spine stabilization using 3D-printed model planning in people with Spine Trauma (Thoracic and Lumbar), run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Zrzavecky, M.D. (+420 775 714 266, marek.zrzavecky@kzcr.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss (time frame: Peroperative (during surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.