Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures

NCT07471568 | Active Not Recruiting

• 2 other identifiers: UCV2025-2026-091UCV/2025-2026/093
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 12 months after study inclusion or until the final planned follow-up visit.

Secondary Outcomes (8)

• Pain Intensity Change (VAS)

  Through study completion, up to 12 months after injury.

• Duration of Sick Leave (Days)

  Up to 12 months after injury.

• Functional Recovery Status at Final Follow-Up

  Up to 12 months after study inclusion.

• Return-to-Work Rate

  Through study completion, up to 12 months after injury.

• Incidence of Treatment-Related Complications

  Through study completion, up to 12 months after injury.

Other Outcomes (3)

• Level of Vertebral Fracture Involved

  Baseline

• Mechanism of Injury Distribution

  Baseline

• Mortality

  Through study completion, up to 12 months after injury.

Study Arms (3)

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. \[bing.com\]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, 46015, Spain

Location

Related Publications (14)

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Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2007
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)