The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures

NCT07027306 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 648

Last updated 2026-05-13

No results posted yet for this study

Summary

This is an international multicenter prospective observational study. Patients with radiologically confirmed, symptomatic, single- or multilevel contiguous TL (from T1 to L5) fractures as a result of primary osteoporosis will be recruited from participating clinics/hospitals (ie, study sites). Fractures included are insufficiency fractures (confirmed by magnetic resonance imaging \[MRI\]) and traumatic fractures (low-energy trauma, confirmed by computed tomography \[CT\] or MRI).

Conditions

Interventions

PROCEDURE

Posterior stabilization (pedicle screws)

* Any other type of solely vertebral augmentation (stents, etc.), specify * Posterior stabilization (pedicle screws) * Posterior stabilization (pedicle screws) with kyphoplasty/vertebroplasty * Posterior stabilization (pedicle screws) with screw augmentation * Posterior stabilization (pedicle screws) with screw augmentation and kyphoplasty/vertebroplasty * Posterior stabilization (pedicle screws) with vertebral osteotomy (pedicle subtraction osteotomy or similar) * Combined posterior and anterior stabilization

Sponsors & Collaborators

  • AO Foundation, AO Spine

    lead OTHER

Principal Investigators

  • Klaus Schnake, MD · Center for Spinal and Scoliosis Surgery

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2028-12-01
Completion
2030-12-01

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Egypt
  • Finland
  • Germany
  • India
  • Japan
  • Malaysia
  • Romania
  • Saudi Arabia
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07027306 on ClinicalTrials.gov