Actively Recruiting

Age: 50Years +
All Genders
NCT07027306

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

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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