Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures (TRAUMA-A1)

March 10, 2026 updated by: Vicente Vanaclocha, University of Valencia

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

146

Contacts and Locations

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

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46015
        • Consorcio Hospital General Universitario de Valencia

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 12 months after study inclusion or until the final planned follow-up visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Change (VAS)
Time Frame: Through study completion, up to 12 months after injury.

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.
Through study completion, up to 12 months after injury.
Duration of Sick Leave (Days)
Time Frame: Up to 12 months after injury.
Number of days of temporary work disability, calculated from the injury date to the officially documented date of return to work.
Up to 12 months after injury.
Functional Recovery Status at Final Follow-Up
Time Frame: Up to 12 months after study inclusion.
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.
Up to 12 months after study inclusion.
Return-to-Work Rate
Time Frame: Through study completion, up to 12 months after injury.
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.
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.
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.
Through study completion, up to 12 months after injury.
Radiological Outcomes
Time Frame: Through study completion, up to 12 months after injury.
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
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.
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.
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.
Detection of associated radiological findings-including edema, ligamentous changes, or other vertebral abnormalities-on magnetic resonance imaging (MRI), CT, or radiography per institutional protocol.
Through study completion, up to 12 months after injury.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Vertebral Fracture Involved
Time Frame: Baseline
Distribution of affected vertebral levels (T4-S1)
Baseline
Mechanism of Injury Distribution
Time Frame: Baseline
Classification of injury mechanism (falls from height, road accidents, heavy lifting injuries)
Baseline
Mortality
Time Frame: Through study completion, up to 12 months after injury.
Mortality rate documented in the clinical record from the time of injury through the end of follow-up.
Through study completion, up to 12 months after injury.

Collaborators and Investigators

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

Sponsor

University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2007

Primary Completion (Actual)

February 1, 2025

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCV2025-2026-091
  • UCV/2025-2026/093 (Other Identifier: Ethics committee approval code (Catholic University of Valencia, Spain))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

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.

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