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

Part of paid clinical trials in San Francisco, California.

Sponsor
AO Foundation, AO Spine
Study ID
NCT07027306
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Posterior stabilization (pedicle screws) — PROCEDURE
    * Any other type of solely vertebral augmentation (stents, etc.), specify * Posterior stabilization (pedicle screws) * Posterior stabilization (pedicle screws) with kyphoplasty/vertebroplasty * Posterior stabilization (pedicle screws) with screw augmentation * Posterior stabilization (pedicle screws) with screw augmentation and kyphoplasty/vertebroplasty * Posterior stabilization (pedicle screws) with vertebral osteotomy (pedicle subtraction osteotomy or similar) * Combined posterior and anterior stabilization

Study Details

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 Dates

Start date
Mar 19, 2026
Status verified
May 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2030

Study Design

Enrollment
648 participants (estimated)

Arms

  • Arm: OF score accordance group
    Initial treatment decision in accordance with the OF score recommendations
  • Arm: OF score discordance group
    Initial treatment decision in discordance with the OF score recommendations

Primary Outcome Measure

Return to mobility [ Time Frame: From day of treatment to the end of the first 3 months after treatment. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California San Francisco (USCF) Department of Orthopaedic SurgerySan FranciscoCalifornia94143-0728
Ashraf El Naga, MD
[email protected]
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-4216
Alexander R Vaccaro, MD
[email protected]

Find similar trials in San Francisco, CA

By research site
University of California San Francisco (USCF) Department of Orthopaedic Surgery· San Francisco, CAThomas Jefferson University Hospital· Philadelphia, PA

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