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

Recruiting now

Conditions studied: Osteoporotic Fractures, Osteoporosis

In brief

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).

Key facts

Study ID: NCT07027306
Run by: AO Foundation, AO Spine
People needed: 648
Starts: 2026-03-19
Expected to finish: 2030-12-01
Last updated by the study team: 2026-05-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Security Force Hospital — Riyāḑ, Saudi Arabia (enrolling)
Island Hospital Spine Centre — George Town, Malaysia (enrolling)
Spiatlul Clinic De Urgenta, "Profesor Doctor Nicolae Oblu" — Iași, Romania (enrolling)
Cajuru University Hospital — Curitiba, Brazil
Department of Orthopedic Surgery, Clinica Alemana de Santiago — Santiago, Chile
Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine — Asyut, Egypt
Tampere University Hospital — Tampere, Finland
Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien — Erlangen, Germany
PGIMER - Postgraduate Institute of Medical Education and Research — Chandigarh, India
Dokkyo Medical University Hospital — Tochigi, Japan
Spital Emmental - Orthopädie Sonnenhof — Burgdorf, Switzerland
University of California San Francisco (USCF) Department of Orthopaedic Surgery — San Francisco, California, United States
King's College Hospital — London, United Kingdom
Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
Sanatorio Güemes — Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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