Actively Recruiting
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
Led by AO Foundation, AO Spine · Updated on 2026-05-13
648
Participants Needed
15
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women 50 years or older or men older than 60 years
- Radiologically confirmed symptomatic single or contiguous multilevel thoracolumbar fractures (T1 to L5)
- Fractures confirmed by MRI as insufficiency fractures or by CT or MRI as low-energy traumatic fractures
- Fractures resulting from primary osteoporosis diagnosed by T-score ≤ -2.5 or presence of fragility fractures
- Fractures classified as OF 1 to OF 5 according to the Osteoporotic Fracture Classification
- Ability to provide informed consent according to ethical guidelines
You will not qualify if you...
- Presence of spinal tumors
- Concomitant cervical fractures
- Signs of spinal infections
- Fractures caused by high-energy or high-impact trauma
- Concomitant fractures in pelvis or limbs affecting mobility or pain
- Inability to attend follow-up visits
- Previous instrumented surgery in affected spine levels
- Fractures adjacent to previous instrumented surgery
- Mental impairment preventing adherence to study procedures
- Bedridden status before the index fracture
- Recent substance abuse affecting reliable assessment
- Participation in other medical device or drug studies within the past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of California San Francisco (USCF) Department of Orthopaedic Surgery
San Francisco, California, United States, 94143-0728
Not Yet Recruiting
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107-4216
Not Yet Recruiting
3
Sanatorio Güemes
Buenos Aires, Argentina, 1240
Not Yet Recruiting
4
Cajuru University Hospital
Curitiba, Brazil, 80050-50
Not Yet Recruiting
5
Department of Orthopedic Surgery, Clinica Alemana de Santiago
Santiago, Chile, 5951
Not Yet Recruiting
6
Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine
Asyut, Egypt, 71526
Not Yet Recruiting
7
Tampere University Hospital
Tampere, Finland, 33521
Not Yet Recruiting
8
Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien
Erlangen, Germany, 91054
Not Yet Recruiting
9
PGIMER - Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160 012
Not Yet Recruiting
10
Dokkyo Medical University Hospital
Tochigi, Japan, 321-0293
Not Yet Recruiting
11
Island Hospital Spine Centre
George Town, Malaysia, 10450
Actively Recruiting
12
Spiatlul Clinic De Urgenta, "Profesor Doctor Nicolae Oblu"
Iași, Romania, 700309
Actively Recruiting
13
Security Force Hospital
Riyāḑ, Saudi Arabia, 11564
Actively Recruiting
14
Spital Emmental - Orthopädie Sonnenhof
Burgdorf, Switzerland, 3400
Not Yet Recruiting
15
King's College Hospital
London, United Kingdom, SE5 9RS
Not Yet Recruiting
Research Team
F
Felix Thomas Thomas, PhD
CONTACT
M
Maria C Medina Giner
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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