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Not Yet Recruiting NCT07706439

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

Conditions: Thoracolumbar Low-energy Vertebral Compression Fractures

Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 400
Sponsor: University Hospital, Grenoble

Location: Grenoble Alpes university Hospital La Tronche

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 Criteria

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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07706439). StuddyBuddy aggregates publicly available trial information.