The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study
AO Foundation, AO Spine
648 participants
Mar 10, 2026
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria15
- 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 is based on any of the followings in the absence of causes for secondary osteoporosis (such as long-term use of steroids, rheumatoid arthritis, type 1 diabetes mellitus \[DM\], and other metabolic bone disorders \[eg, rickets/osteomalacia, Paget's disease, osteogenesis imperfecta, and primary hyperparathyroidism\]) \[13-15\]:
- A T-score ≤ -2.5 in the lumbar spine, femoral neck, total hip, or 1/3 radius
- Presence of fragility fracture (either a previous fragility fracture or the index fracture is a fragility fracture). Fragility fractures are fractures due to no or low-energy trauma, eg, slips, trips, or falls from less than double the body height, and heavy lifting.
- The index osteoporotic TL fracture being classified based on the OF Classification from OF 1 to OF 5:
- OF 1: No deformation (vertebral body edema on MRI using short tau inversion recovery \[STIR\] sequence)
- OF 2: Deformation of one endplate
- OF 3: Deformation of one endplate with distinct posterior wall involvement
- OF 4: Deformation of both endplates with/without posterior wall involvement
- OF 5: Injuries with anterior or posterior tension band failure
- Ability to provide informed consent according to the EC/IRB defined and approved procedures
Exclusion Criteria12
- Patients with spinal tumors
- Patients with concomitant cervical fractures
- Patients showing any signs of spinal infections
- Patients with fractures due to high-energy or high-impact trauma, eg, a fall from double the body height or higher, motor vehicle accident with \> 100 km/h in cars with airbags, or motor vehicle accident \> 50 km/h without airbags, polytrauma
- Patients with concomitant fracture in the pelvis, upper extremities, and/or lower extremities which could affect the main study outcomes (specifically, patient mobility and pain)
- Patients for whom no FUs are possible
- Previous instrumented surgery in the affected spine levels
- Patients with single-level fracture or contiguous multilevel fracture adjacent to previous instrumented surgery
- Patients who are mentally impaired and therefore not able to adhere to the study procedures and data collection
- Patients who are bedridden before the index fracture
- Recent history of substance abuse (ie, recreational drugs and alcohol) that would preclude reliable assessments
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
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Interventions
* 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)
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NCT07027306