Spine FractureNCT07516834
Three Dimensional Gait Analysis and Electromyography After Stabilisation of Thoracolumbar Spine Fractures Focusing on Possible Temporal Diferences in Physiological Gait Recovery Through Comparison of Open and Minimally Invasive Approaches.
A study testing spine stabilization in people with Spine Fracture, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial summary
We prospectively enrolled patients with a thoracic or lumbar spine fracture indicated for instrumented posterior stabilization. We consequently randomized the patient for either a conventional open approach procedure or minimally invasive surgery. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Spine Fracture
- What is being tested?
- spine stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Feb 2022to Jul 2026
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fracture of thoracic or lumbar spine indicated for spine stabilization
Who cannot join
- neurological deficits as a consequence of the primary spine trauma
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
Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem, Ústí Nad Labem, Ustecky kraj 40001
Ústí nad Labem, Ústí nad Labem Region, 40001
Jan Soukup, M.D., +420723705376, Soukup07@kzcr.eu
About this study
Official title: 3D Gait Analysis and Electromyography After Instrumented Stabilisation of Thoracolumbar Spine Fractures - Comparison Between Open and Minimally Invasive Approach
We prospectively enrolled patients with a thoracic or lumbar spine fracture indicated for instrumented posterior stabilization. We consequently randomized the patient for either a conventional open approach procedure or minimally invasive surgery. 3DGA analysis was carried out at specific time points after surgery together with electromyography of deep-plane back muscles.
- Conditions
- Spine Fracture
- Being tested
- spine stabilization
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spine stabilizationProcedure or surgery
transpedicular screws posterior spine stabilization
| Study group | Role | What they receive |
|---|---|---|
| Open approach posterior stabilization of either thoracic or lumbar spine fracture | Active comparator | Not described Receives: Procedure: spine stabilization |
| Minimally invasive approach posterior stabilization of either thoracic or lumbar spine fracture | Active comparator | Not described Receives: Procedure: spine stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D Gait Analysis - Gait Profile Score
Measured: 2 weeks postoperative - 1 year postoperative
Secondary outcomes (1)
Electromyography of deep-plane spine muscles
Measured: 2 weeks postoperative - 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Feb 2022
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FractureStudies 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
- 20 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
- Investigators
- Jan Soukup, M.D., Principal investigator, Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem, Ústí Nad Labem, Ustecky kraj 40001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516834
- Sponsor's protocol ID
- 3DGASPINE
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Gait Analysis and Electromyography After Instrumented Stabilisation of Thoracolumbar Spine Fractures - Comparison Between Open and Minimally Invasive Approach
- ClinicalTrials.gov ID
- NCT07516834
- Acronym / sponsor ID
- 3DGASPINE
- Conditions
- Spine Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Apr 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.
We prospectively enrolled patients with a thoracic or lumbar spine fracture indicated for instrumented posterior stabilization. We consequently randomized the patient for either a conventional open approach procedure or minimally invasive surgery. 3DGA analysis was carried out at specific time points after surgery together with electromyography of deep-plane back muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open approach posterior stabilization of either thoracic or lumbar spine fracture | Active comparator | Procedure: spine stabilization |
| Minimally invasive approach posterior stabilization of either thoracic or lumbar spine fracture | Active comparator | Procedure: spine stabilization |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fracture of thoracic or lumbar spine indicated for spine stabilization
Key exclusion criteria (1 listed)
- neurological deficits as a consequence of the primary spine trauma
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 stabilizationtranspedicular screws posterior spine stabilization | Procedure or surgery | Minimally invasive approach posterior stabilization of either thoracic or lumbar spine fracture, Open approach posterior stabilization of either thoracic or lumbar spine fracture |
Primary outcome
3D Gait Analysis - Gait Profile Score
Time frame: 2 weeks postoperative - 1 year postoperative
1 secondary outcome
Electromyography of deep-plane spine muscles
Time frame: 2 weeks postoperative - 1 year postoperative
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 8 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Jan Soukup, M.D. principal investigator
Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem, Ústí Nad Labem, Ustecky kraj 40001
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 in people with Spine Fracture, 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 8 Apr 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 Jan Soukup, M.D. (+420723705376, Soukup07@kzcr.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D Gait Analysis - Gait Profile Score (time frame: 2 weeks postoperative - 1 year postoperative). 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 8 Apr 2026.