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

Launched by AO FOUNDATION, AO SPINE · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help doctors decide the best treatment for people who have fractures in their spine caused by osteoporosis, a condition that weakens bones. The study will look at patients who have recently had one or more fractures in the middle or lower part of their spine (from the upper back down to the lower back) that are confirmed by special imaging tests like MRI or CT scans. These fractures happen either from everyday low-impact events, like a minor fall, or because the bones are fragile due to osteoporosis.

People who might take part in this study include women over 50 who have gone through menopause, or men over 60, with new spine fractures caused by weakened bones from osteoporosis. Participants need to be able to understand the study and agree to join. The study will observe these patients over time to see how their fractures heal and how different types of fractures respond to treatment. This research aims to improve how doctors classify these fractures and choose the best care for each patient. If you qualify, you can expect regular check-ups and imaging tests, but no new treatments will be tested—this study is focused on learning from real patient experiences to guide future care.

Gender

ALL

Eligibility criteria

• 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