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
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
- Osteoporotic Fractures
- Osteoporosis
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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