Clinical Research Directory

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 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 Criteria: * 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