Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:56 PM
Study NCT ID:
NCT07471568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures
Sponsor:
University of Valencia
Organization:
Study Overview
Official Title:
Comparative Outcomes of Orthopedic Bracing, Percutaneous Vertebroplasty, and Spinal Arthrodesis for Traumatic AO Type A1 Vertebral Fractures: A Retrospective Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAUMA-A1
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UCV/2025-2026/093 | OTHER | Ethics committee approval code (Catholic University of Valencia, Spain) | View |