The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorAO Foundation, AO Spine
About this trial
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
Qualifiers
Postmenopausal women ≥ 50 years old or men > 60 years old
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Posterior stabilization (pedicle screws)
Treatment groups
648 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov