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

Prior treatment

• Patients with concomitant cervical fractures
• 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)
• Previous instrumented surgery in the affected spine levels
• Patients with single-level fracture or contiguous multilevel fracture adjacent to previous instrumented surgery
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Other illness

• Patients showing any signs of spinal infections
• Recent history of substance abuse (ie, recreational drugs and alcohol) that would preclude reliable assessments

Other

• Patients with spinal tumors
• 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 for whom no FUs are possible
• 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

• 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