The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study
AO Foundation, AO Spine
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).
Description
This is an international multicenter prospective observational study. Postmenopausal women ≥ 50 years old and men \> 60 years old 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). All osteoporotic TL fractures will be classified using the OF c…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Postmenopausal women ≥ 50 years old or men \> 60 years old o Menopause refers to amenorrhea for 1 complete year. * Radiologically confirmed new diagnosis of symptomatic, single or multilevel TL (from T1 to L5) fractures, ie, the index fracture(s). * In case of a multilevel fracture, the fracture must be contiguous. * The index fracture is confirmed by MRI as an insufficiency (or fragility) fracture or is confirmed by CT or MRI as traumatic fracture (low-energy trauma) * The index fracture(s) is a result of primary osteoporosis. Diagnosis of primary osteoporosis i…
Interventions
- ProcedurePosterior 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
Locations (15)
- University of California San Francisco (USCF) Department of Orthopaedic SurgerySan Francisco, California
- Thomas Jefferson University HospitalPhiladelphia, Pennsylvania
- Sanatorio GüemesBuenos Aires
- Cajuru University HospitalCuritiba
- Department of Orthopedic Surgery, Clinica Alemana de SantiagoSantiago
- Orthopaedic Department, Assiut University Hospitals, Faculty of MedicineAsyut