NCT07027306 The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
| NCT ID | NCT07027306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AO Foundation, AO Spine |
| Condition | Osteoporotic Fractures |
| Study Type | OBSERVATIONAL |
| Enrollment | 648 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 648 participants in total. It began in 2026-03-19 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Klaus Schnake, MD
PRINCIPAL INVESTIGATOR
Center for Spinal and Scoliosis Surgery
Frequently Asked Questions
Who can join the NCT07027306 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Osteoporotic Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07027306 currently recruiting?
Yes, NCT07027306 is actively recruiting participants. Contact the research team at felix.thomas@aofoundation.org for enrollment information.
Where is the NCT07027306 trial being conducted?
This trial is being conducted at San Francisco, United States, Philadelphia, United States, Buenos Aires, Argentina, Curitiba, Brazil and 11 additional locations.
Who is sponsoring the NCT07027306 clinical trial?
NCT07027306 is sponsored by AO Foundation, AO Spine. The principal investigator is Klaus Schnake, MD at Center for Spinal and Scoliosis Surgery. The trial plans to enroll 648 participants.