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Starting soon Observational

Large-Scale Evaluation of a Clinical Decision Tree for the Management of Low-Energy Thoracic and Lumbar Vertebral Compression Fractures.

NCT07706439 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-07-15
Last updated
2026-07-17

Condition(s) studied

Thoracolumbar Low-energy Vertebral Compression Fractures

Study summary

Percutaneous vertebroplasty is widely used for low-energy vertebral compression fractures, but its clinical benefits remain debated. Studies and meta-analyses have reported mixed results, while complications occur in a significant proportion of patients, highlighting the importance of careful patient selection. To standardize management, a clinical decision tree was developed based on patient age, MRI findings, pain severity (VAS), and radiological deformity.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Age \> 50 years * One or more low-energy vertebral compression fractures (LEVCFs) confirmed by MRI * Fractures located between T7 and L5 * Compression fractures classified as A1.1, A1.2, or A1.3 according to the Magerl classification \[15\] * Management in accordance with the clinical decision tree * Vertebroplasty performed by an interventional radiologist, orthopedic surgeon, or neurosurgeon * Vertebral augmentation performed by an orthopedic surgeon or neurosurgeon, with or without navigation assistance * Conservative treatment consisting of a lumbar brace worn during daytime, with duration individualized according to the patient's needs, and physiotherapy initiated between 45 and 90 days after treatment, including core stabilization, stretching, and strengthening of the posterior muscle chain and abdominal muscles, based on active rehabilitation rather than manual therapy (no massage therapy). Exclusion Criteria: * Pregnant or breastfeeding women * Individuals under administrative or judicial supervision * Age \< 50 years or \> 90 years * Pathological vertebral fracture * Presence of other osteoporotic fractures during the study follow-up period (6 months) * Non-compliance with the clinical decision tree * Dementia or cognitive impairment preventing data collection at the final follow-up (telephone interview), assessed using the Mini-Cog test (score \< 3 = exclusion) * Refusal to participate during the telephone interview or inability to provide non-opposition (e.g., under legal guardianship)

Primary outcome measure(s)

  • Evaluate the clinical and radiological healing outcomes of patients managed according to a clinical decision tree for one or more low-energy vertebral compression fractures (LEVCFs) — 1 year
    Radiological fracture healing, assessed on standard radiographs based on cortical continuity, disappearance of fracture lines, absence of progressive kyphosis, and absence of osteosynthesis hardware-related complications. Fracture healing will be classified as complete, partial, or absent.

Trial sites (1)

FacilityCityRegionStatus
Grenoble Alpes university Hospital La Tronche France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07706439 on ClinicalTrials.gov ↗ ← All trials in France