Traumatic Vertebral FracturesTRAUMA-A1NCT07471568
Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures
An observational study of Traumatic Vertebral Fractures and Compression Fractures of the Spine, run by University of Valencia at 1 site in Spain.
Trial summary
This retrospective study evaluates three different treatment approaches used for traumatic AO Spine Type A1 (A1) vertebral fractures: orthopedic bracing, percutaneous vertebroplasty, and spinal arthrodesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Vertebral Fractures, Compression Fractures of the Spine, AO Type A1 Vertebral Fracture
- How many people
- 146 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2007to 1 Feb 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 years or older who sustained traumatic AO Type A1 vertebral fractures and received treatment at Hospital 9 de Octubre in Valencia, Spain. These patients were managed with one of three real-world therapeutic strategies-orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis-and have available clinical and imaging records documenting their injury, treatment, and follow-up
Who may be able to join
- Adults aged 18 years or older with a traumatic AO Type A1 vertebral fracture confirmed by clinical records and imaging studies. Patients must have been treated with one of the following management strategies: orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis. Complete clinical records must be available for review, including the mechanism of injury, level of the fracture, treatment performed, and follow-up information.
- Patients younger than 18 years; patients with non-traumatic or osteoporotic vertebral fractures; vertebral fractures not classified as AO Spine Type A1; cases with incomplete medical records; or patients whose fractures were treated for indications other than trauma. Patients with missing essential follow-up data will also be excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46015
About this study
Official title: Comparative Outcomes of Orthopedic Bracing, Percutaneous Vertebroplasty, and Spinal Arthrodesis for Traumatic AO Type A1 Vertebral Fractures: A Retrospective Clinical Study
This retrospective study evaluates three different treatment approaches used for traumatic AO Spine Type A1 (A1) vertebral fractures: orthopedic bracing, percutaneous vertebroplasty, and spinal arthrodesis. Traumatic A1 fractures are stable compression fractures that occur after high-energy events such as falls, traffic accidents, or heavy lifting. These injuries often affect working-age adults and can lead to significant pain, temporary disability, and delays in returning to work. The study analyzes real-world clinical data from patients treated at Hospital 9 de Octubre in Valencia, Spain, between 2007 and 2025. Outcomes assessed include pain levels, duration of sick leave, time to return to work, final functional status, and the presence of complications. By comparing the results of these three treatment strategies, the study aims to identify which approach offers the best clinical recovery and work-related outcomes for patients with traumatic AO Spine Type A1 fractures.
Read the detailed description
Traumatic AO Spine Type A1 (A1) vertebral fractures are stable compression injuries typically caused by high-energy mechanisms such as falls from height, road-traffic accidents, or heavy lifting. These injuries frequently affect adults of working age and may lead to acute pain, temporary functional limitations, and prolonged periods of sick leave. In the clinical setting represented in this study, affected patients underwent one of three treatment strategies: orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis.
Orthopedic bracing is the most commonly used conservative approach for stable vertebral compression fractures. In contrast, percutaneous vertebroplasty is a minimally invasive technique that provides immediate internal stabilization via injection of polymethylmethacrylate (PMMA) cement, potentially reducing pain and accelerating functional recovery. Spinal arthrodesis, although more invasive, may be selected in specific traumatic scenarios depending on fracture morphology, associated injuries, or surgeon preference. Despite the frequent use of all three strategies, comparative evidence regarding clinical, functional, and work-related outcomes in traumatic AO Spine Type A1 fractures remains limited.
This retrospective cohort study examines real-world outcomes of patients with traumatic AO Spine Type A1 vertebral fractures treated at Hospital 9 de Octubre in Valencia, Spain. The study includes clinical data collected between 2007 and 2025, covering patients who were managed with one of the three treatment modalities. Data elements include demographic characteristics, mechanism of injury, fracture level, pre-treatment pain scores, treatment type, functional recovery, duration of sick leave, return-to-work (RTW) dates, and long-term clinical status. These variables are systematically documented in the institutional dataset supporting the project.
Imaging studies, including radiographs, computed tomography (CT), and magnetic resonance imaging (MRI), were routinely performed at the institution to evaluate vertebral morphology, rule out ligamentous injury, and assess neurological involvement. Advanced imaging also provided objective confirmation of fracture stability, enabling classification as AO Spine Type A1.
The primary aim of this study is to compare overall clinical recovery among patients treated with orthopedic bracing, vertebroplasty, or arthrodesis. Secondary outcomes include duration of work disability, pain evolution, and the presence of complications or adverse events. Long-term outcomes are available for many patients, with the latest follow-up recorded in February 2025.
By analyzing outcomes across these three management strategies, the study seeks to clarify which approach provides the most favorable clinical and occupational results for adults with traumatic AO Spine Type A1 vertebral fractures. The findings may inform clinical decision-making, help refine treatment algorithms, and support more individualized management strategies for this common traumatic condition.
- Conditions
- Traumatic Vertebral Fractures, Compression Fractures of the Spine, AO Type A1 Vertebral Fracture, Spinal Trauma
- Keywords
- Traumatic Vertebral Fracture, Spinal Compression Fracture, Spinal Trauma, Orthopedic Bracing, Percutaneous Vertebroplasty, Spinal Arthrodesis, Work-Related Spinal Injury, Return to Work, Sick Leave Duration, Clinical Outcomes, Retrospective Cohort Study, AO Spine Type A1 Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic Bracing | Participants with traumatic AO Type A1 vertebral fractures treated with external orthopedic bracing (conservative management). | |
| Percutaneous Vertebroplasty | Participants with traumatic AO Type A1 vertebral fractures treated with percutaneous vertebroplasty using PMMA cement. | |
| Spinal Arthrodesis | Participants with traumatic AO Type A1 vertebral fractures treated with surgical spinal fusion (arthrodesis), including instrumented stabilization. [bing.com] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Recovery Status at Final Follow-Up
Degree of functional recovery after treatment of traumatic AO Spine Type A1 vertebral fractures, assessed using the final documented clinical status categories recorded in the medical chart. Functional categories include:
full recovery minor residual spinal pain partial work disability no return to work permanent disability
Higher categories indicate worse functional outcome (e.g., "full recovery" is the best outcome; "permanent disability" is the worst).
Measured: Up to 12 months after study inclusion or until the final planned follow-up visit.
Secondary outcomes (8)
Pain Intensity Change (VAS)
Change in pain intensity measured using the Visual Analog Scale for pain (VAS).
The VAS ranges from 0 to 10, where:
0 = no pain 10 = worst imaginable pain
Higher VAS scores indicate worse pain. The measure compares pre-treatment VAS values with last follow-up VAS values documented in the registry.
Measured: Through study completion, up to 12 months after injury.
Duration of Sick Leave (Days)
Number of days of temporary work disability, calculated from the injury date to the officially documented date of return to work.
Measured: Up to 12 months after injury.
Functional Recovery Status at Final Follow-Up
Degree of functional recovery after treatment of traumatic AO Type A1 vertebral fractures, assessed using the final documented clinical status ("Full recovery," "Minor residual spinal pain," "Partial work disability," "No return to work," or "Permanent disability") extracted from clinical records.
Measured: Up to 12 months after study inclusion.
Return-to-Work Rate
Proportion of patients who successfully return to work after treatment for traumatic AO Spine Type A1 vertebral fractures, based on documented work-resumption status in the clinical record.
Measured: Through study completion, up to 12 months after injury.
Incidence of Treatment-Related Complications
Incidence of treatment-related complications documented in the medical record, including persistent pain, secondary procedures, new neurological symptoms, or other adverse events occurring after treatment for traumatic AO Spine Type A1 vertebral fractures.
Measured: Through study completion, up to 12 months after injury.
Radiological Outcomes
Evaluation of vertebral morphology changes after treatment, including vertebral body height, wedge deformity, and overall structural appearance as documented in radiographic and computed tomography (CT) imaging
Measured: Through study completion, up to 12 months after injury.
Radiological Assessment of Fracture Stability
Evaluation of radiological signs of stability or instability of the vertebral fracture on radiography and CT, including progression of collapse, kyphotic angulation, or evidence of motion on flexion-extension imaging when available.
Measured: Through study completion, up to 12 months after injury.
Radiological Assessment of Associated Injuries
Detection of associated radiological findings-including edema, ligamentous changes, or other vertebral abnormalities-on magnetic resonance imaging (MRI), CT, or radiography per institutional protocol.
Measured: Through study completion, up to 12 months after injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Mar 2007
- Primary completionFeb 2025
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Traumatic Vertebral FracturesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Vanaclocha, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471568
- Sponsor's protocol ID
- UCV2025-2026-091
- Other IDs
- UCV/2025-2026/093
- Acronym
- TRAUMA-A1
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is based on retrospective clinical records containing potentially identifiable information, and the ethics committee approval does not include authorization to publicly share individual-level data
Publications
Singh J, Baker MD, Morris PP, Whitlow CT. Percutaneous pediculoplasty for traumatic pedicle fracture. A technical case report. Interv Neuroradiol. 2012 Jun;18(2):221-6. doi: 10.1177/159101991201800216. Epub 2012 Jun 4.
PubMed 22681740Wang J, Yang H, Ganau M, Wang Y, Miao J, Yan L, Wang B. A comparative analysis of three distinct approaches for the management of type A1 traumatic thoracolumbar fractures: a retrospective cohort study with a minimum 6-year follow-up. J Orthop Surg Res. 2025 Sep 26;20(1):856. doi: 10.1186/s13018-025-06262-5.
PubMed 41013774Bousson V, Hamze B, Odri G, Funck-Brentano T, Orcel P, Laredo JD. Percutaneous Vertebral Augmentation Techniques in Osteoporotic and Traumatic Fractures. Semin Intervent Radiol. 2018 Oct;35(4):309-323. doi: 10.1055/s-0038-1673639. Epub 2018 Nov 5.
PubMed 30402014Perry A, Mahar A, Massie J, Arrieta N, Garfin S, Kim C. Biomechanical evaluation of kyphoplasty with calcium sulfate cement in a cadaveric osteoporotic vertebral compression fracture model. Spine J. 2005 Sep-Oct;5(5):489-93. doi: 10.1016/j.spinee.2005.03.011.
PubMed 16153574Hammed A, Mahfoud M, Mohamad O. Effectiveness of unilateral percutaneous vertebroplasty for acute traumatic non-osteoporotic compression vertebral fractures. Medicine (Baltimore). 2023 Sep 15;102(37):e35177. doi: 10.1097/MD.0000000000035177.
PubMed 37713855Knavel EM, Thielen KR, Kallmes DF. Vertebroplasty for the treatment of traumatic nonosteoporotic compression fractures. AJNR Am J Neuroradiol. 2009 Feb;30(2):323-7. doi: 10.3174/ajnr.A1356. Epub 2008 Nov 27.
PubMed 19039045Donnally III CJ, Margetis K, Varacallo MA. Vertebral Compression Fractures. 2025 May 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448171/
PubMed 28846351Kim BG, Dan JM, Shin DE. Treatment of thoracolumbar fracture. Asian Spine J. 2015 Feb;9(1):133-46. doi: 10.4184/asj.2015.9.1.133. Epub 2015 Feb 13.
PubMed 25705347Peev N, Zileli M, Sharif S, Arif S, Brady Z. Indications for Nonsurgical Treatment of Thoracolumbar Spine Fractures: WFNS Spine Committee Recommendations. Neurospine. 2021 Dec;18(4):713-724. doi: 10.14245/ns.2142390.195. Epub 2021 Dec 31.
PubMed 35000324Vaccaro AR, Lehman RA Jr, Hurlbert RJ, Anderson PA, Harris M, Hedlund R, Harrop J, Dvorak M, Wood K, Fehlings MG, Fisher C, Zeiller SC, Anderson DG, Bono CM, Stock GH, Brown AK, Kuklo T, Oner FC. A new classification of thoracolumbar injuries: the importance of injury morphology, the integrity of the posterior ligamentous complex, and neurologic status. Spine (Phila Pa 1976). 2005 Oct 15;30(20):2325-33. doi: 10.1097/01.brs.0000182986.43345.cb.
PubMed 16227897Giele BM, Wiertsema SH, Beelen A, van der Schaaf M, Lucas C, Been HD, Bramer JA. No evidence for the effectiveness of bracing in patients with thoracolumbar fractures. Acta Orthop. 2009 Apr;80(2):226-32. doi: 10.3109/17453670902875245.
PubMed 19404808Urquhart JC, Alrehaili OA, Fisher CG, Fleming A, Rasoulinejad P, Gurr K, Bailey SI, Siddiqi F, Bailey CS. Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis. J Neurosurg Spine. 2017 Jul;27(1):42-47. doi: 10.3171/2016.11.SPINE161031. Epub 2017 Apr 14.
PubMed 28409669Magerl F, Aebi M, Gertzbein SD, Harms J, Nazarian S. A comprehensive classification of thoracic and lumbar injuries. Eur Spine J. 1994;3(4):184-201. doi: 10.1007/BF02221591.
PubMed 7866834Vaccaro AR, Schroeder GD, Kepler CK, Cumhur Oner F, Vialle LR, Kandziora F, Koerner JD, Kurd MF, Reinhold M, Schnake KJ, Chapman J, Aarabi B, Fehlings MG, Dvorak MF. The surgical algorithm for the AOSpine thoracolumbar spine injury classification system. Eur Spine J. 2016 Apr;25(4):1087-94. doi: 10.1007/s00586-015-3982-2. Epub 2015 May 8.
PubMed 25953527
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Orthopedic Bracing, Percutaneous Vertebroplasty, and Spinal Arthrodesis for Traumatic AO Type A1 Vertebral Fractures: A Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT07471568
- Acronym / sponsor ID
- TRAUMA-A1 / UCV2025-2026-091
- Conditions
- Traumatic Vertebral Fractures, Compression Fractures of the Spine, AO Type A1 Vertebral Fracture, Spinal Trauma
- Keywords
- Traumatic Vertebral Fracture, Spinal Compression Fracture, Spinal Trauma, Orthopedic Bracing, Percutaneous Vertebroplasty, Spinal Arthrodesis, Work-Related Spinal Injury, Return to Work
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- Feb 2025 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 13 Mar 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.
This retrospective study evaluates three different treatment approaches used for traumatic AO Spine Type A1 (A1) vertebral fractures: orthopedic bracing, percutaneous vertebroplasty, and spinal arthrodesis. Traumatic A1 fractures are stable compression fractures that occur after high-energy events such as falls, traffic accidents, or heavy lifting. These injuries often affect working-age adults and can lead to significant pain, temporary disability, and delays in returning to work. The study analyzes real-world clinical data from patients treated at Hospital 9 de Octubre in Valencia, Spain, between 2007 and 2025. Outcomes assessed include pain levels, duration of sick leave, time to return to work, final functional status, and the presence of complications. By comparing the results of these three treatment strategies, the study aims to identify which approach offers the best clinical recovery and work-related outcomes for patients with traumatic AO Spine Type A1 fractures.
Detailed description
Traumatic AO Spine Type A1 (A1) vertebral fractures are stable compression injuries typically caused by high-energy mechanisms such as falls from height, road-traffic accidents, or heavy lifting. These injuries frequently affect adults of working age and may lead to acute pain, temporary functional limitations, and prolonged periods of sick leave. In the clinical setting represented in this study, affected patients underwent one of three treatment strategies: orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis.
Orthopedic bracing is the most commonly used conservative approach for stable vertebral compression fractures. In contrast, percutaneous vertebroplasty is a minimally invasive technique that provides immediate internal stabilization via injection of polymethylmethacrylate (PMMA) cement, potentially reducing pain and accelerating functional recovery. Spinal arthrodesis, although more invasive, may be selected in specific traumatic scenarios depending on fracture morphology, associated injuries, or surgeon preference. Despite the frequent use of all three strategies, comparative evidence regarding clinical, functional, and work-related outcomes in traumatic AO Spine Type A1 fractures remains limited.
This retrospective cohort study examines real-world outcomes of patients with traumatic AO Spine Type A1 vertebral fractures treated at Hospital 9 de Octubre in Valencia, Spain. The study includes clinical data collected between 2007 and 2025, covering patients who were managed with one of the three treatment modalities. Data elements include demographic characteristics, mechanism of injury, fracture level, pre-treatment pain scores, treatment type, functional recovery, duration of sick leave, return-to-work (RTW) dates, and long-term clinical status. These variables are systematically documented in the institutional dataset supporting the project.
Imaging studies, including radiographs, computed tomography (CT), and magnetic resonance imaging (MRI), were routinely performed at the institution to evaluate vertebral morphology, rule out ligamentous injury, and assess neurological involvement. Advanced imaging also provided objective confirmation of fracture stability, enabling classification as AO Spine Type A1.
The primary aim of this study is to compare overall clinical recovery among patients treated with orthopedic bracing, vertebroplasty, or arthrodesis. Secondary outcomes include duration of work disability, pain evolution, and the presence of complications or adverse events. Long-term outcomes are available for many patients, with the latest follow-up recorded in February 2025.
By analyzing outcomes across these three management strategies, the study seeks to clarify which approach provides the most favorable clinical and occupational results for adults with traumatic AO Spine Type A1 vertebral fractures. The findings may inform clinical decision-making, help refine treatment algorithms, and support more individualized management strategies for this common traumatic condition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orthopedic Bracing | – | –Participants with traumatic AO Type A1 vertebral fractures treated with external orthopedic bracing (conservative management). |
| Percutaneous Vertebroplasty | – | –Participants with traumatic AO Type A1 vertebral fractures treated with percutaneous vertebroplasty using PMMA cement. |
| Spinal Arthrodesis | – | –Participants with traumatic AO Type A1 vertebral fractures treated with surgical spinal fusion (arthrodesis), including instrumented stabilization. [bing.com] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years or older who sustained traumatic AO Type A1 vertebral fractures and received treatment at Hospital 9 de Octubre in Valencia, Spain. These patients were managed with one of three real-world therapeutic strategies-orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis-and have available clinical and imaging records documenting their injury, treatment, and follow-up
Key inclusion criteria (2 listed)
- Adults aged 18 years or older with a traumatic AO Type A1 vertebral fracture confirmed by clinical records and imaging studies. Patients must have been treated with one of the following management strategies: orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis. Complete clinical records must be available for review, including the mechanism of injury, level of the fracture, treatment performed, and follow-up information.
- Patients younger than 18 years; patients with non-traumatic or osteoporotic vertebral fractures; vertebral fractures not classified as AO Spine Type A1; cases with incomplete medical records; or patients whose fractures were treated for indications other than trauma. Patients with missing essential follow-up data will also be excluded.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Recovery Status at Final Follow-Up
Time frame: Up to 12 months after study inclusion or until the final planned follow-up visit.
Degree of functional recovery after treatment of traumatic AO Spine Type A1 vertebral fractures, assessed using the final documented clinical status categories recorded in the medical chart. Functional categories include: full recovery minor residual spinal pain partial work disability no return to work permanent disability Higher categories indicate worse functional outcome (e.g., "full recovery" is the best outcome; "permanent disability" is the worst).
8 secondary outcomes
Pain Intensity Change (VAS)
Time frame: Through study completion, up to 12 months after injury.
Duration of Sick Leave (Days)
Time frame: Up to 12 months after injury.
Functional Recovery Status at Final Follow-Up
Time frame: Up to 12 months after study inclusion.
Return-to-Work Rate
Time frame: Through study completion, up to 12 months after injury.
Incidence of Treatment-Related Complications
Time frame: Through study completion, up to 12 months after injury.
Radiological Outcomes
Time frame: Through study completion, up to 12 months after injury.
Radiological Assessment of Fracture Stability
Time frame: Through study completion, up to 12 months after injury.
Radiological Assessment of Associated Injuries
Time frame: Through study completion, up to 12 months after injury.
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 13 Mar 2026.
- Background: PubMed 22681740Singh J, Baker MD, Morris PP, Whitlow CT. Percutaneous pediculoplasty for traumatic pedicle fracture. A technical case report. Interv Neuroradiol. 2012 Jun;18(2):221-6. doi: 10.1177/159101991201800216. Epub 2012 Jun 4.
- Background: PubMed 41013774Wang J, Yang H, Ganau M, Wang Y, Miao J, Yan L, Wang B. A comparative analysis of three distinct approaches for the management of type A1 traumatic thoracolumbar fractures: a retrospective cohort study with a minimum 6-year follow-up. J Orthop Surg Res. 2025 Sep 26;20(1):856. doi: 10.1186/s13018-025-06262-5.
- Background: PubMed 30402014Bousson V, Hamze B, Odri G, Funck-Brentano T, Orcel P, Laredo JD. Percutaneous Vertebral Augmentation Techniques in Osteoporotic and Traumatic Fractures. Semin Intervent Radiol. 2018 Oct;35(4):309-323. doi: 10.1055/s-0038-1673639. Epub 2018 Nov 5.
- Background: PubMed 16153574Perry A, Mahar A, Massie J, Arrieta N, Garfin S, Kim C. Biomechanical evaluation of kyphoplasty with calcium sulfate cement in a cadaveric osteoporotic vertebral compression fracture model. Spine J. 2005 Sep-Oct;5(5):489-93. doi: 10.1016/j.spinee.2005.03.011.
- Background: PubMed 37713855Hammed A, Mahfoud M, Mohamad O. Effectiveness of unilateral percutaneous vertebroplasty for acute traumatic non-osteoporotic compression vertebral fractures. Medicine (Baltimore). 2023 Sep 15;102(37):e35177. doi: 10.1097/MD.0000000000035177.
- Background: PubMed 19039045Knavel EM, Thielen KR, Kallmes DF. Vertebroplasty for the treatment of traumatic nonosteoporotic compression fractures. AJNR Am J Neuroradiol. 2009 Feb;30(2):323-7. doi: 10.3174/ajnr.A1356. Epub 2008 Nov 27.
- Background: PubMed 28846351Donnally III CJ, Margetis K, Varacallo MA. Vertebral Compression Fractures. 2025 May 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448171/
- Background: PubMed 25705347Kim BG, Dan JM, Shin DE. Treatment of thoracolumbar fracture. Asian Spine J. 2015 Feb;9(1):133-46. doi: 10.4184/asj.2015.9.1.133. Epub 2015 Feb 13.
- Background: PubMed 35000324Peev N, Zileli M, Sharif S, Arif S, Brady Z. Indications for Nonsurgical Treatment of Thoracolumbar Spine Fractures: WFNS Spine Committee Recommendations. Neurospine. 2021 Dec;18(4):713-724. doi: 10.14245/ns.2142390.195. Epub 2021 Dec 31.
- Background: PubMed 16227897Vaccaro AR, Lehman RA Jr, Hurlbert RJ, Anderson PA, Harris M, Hedlund R, Harrop J, Dvorak M, Wood K, Fehlings MG, Fisher C, Zeiller SC, Anderson DG, Bono CM, Stock GH, Brown AK, Kuklo T, Oner FC. A new classification of thoracolumbar injuries: the importance of injury morphology, the integrity of the posterior ligamentous complex, and neurologic status. Spine (Phila Pa 1976). 2005 Oct 15;30(20):2325-33. doi: 10.1097/01.brs.0000182986.43345.cb.
- Background: PubMed 19404808Giele BM, Wiertsema SH, Beelen A, van der Schaaf M, Lucas C, Been HD, Bramer JA. No evidence for the effectiveness of bracing in patients with thoracolumbar fractures. Acta Orthop. 2009 Apr;80(2):226-32. doi: 10.3109/17453670902875245.
- Background: PubMed 28409669Urquhart JC, Alrehaili OA, Fisher CG, Fleming A, Rasoulinejad P, Gurr K, Bailey SI, Siddiqi F, Bailey CS. Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis. J Neurosurg Spine. 2017 Jul;27(1):42-47. doi: 10.3171/2016.11.SPINE161031. Epub 2017 Apr 14.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is based on retrospective clinical records containing potentially identifiable information, and the ethics committee approval does not include authorization to publicly share individual-level data
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Vertebral Fractures and Compression Fractures of the Spine, run by University of Valencia at 1 site in Spain.
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 2 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 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 Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Recovery Status at Final Follow-Up (time frame: Up to 12 months after study inclusion or until the final planned follow-up visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07471568, which also lists 14 linked publications.
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 13 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.