Large-Scale Evaluation of a Clinical Decision Tree for the Management of Low-Energy Thoracic and Lumbar Vertebral Compression Fractures.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Thoracolumbar Low-energy Vertebral Compression Fractures. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Percutaneous vertebroplasty was first described in France in 1987 . Since its introduction, this minimally invasive technique has become widely accepted and is now a routine treatment for low-energy vertebral compression fractures (LEVCFs), also referred to as vertebral "crush" fractures. Clinical outcomes, including pain relief, analgesic consumption, and quality of life assessed through self-administered questionnaires, are commonly used to evaluate the effectiveness of the procedure.
Over the past 20 years, several randomized controlled trials (RCTs) have been conducted to assess the efficacy of vertebroplasty compared with non-surgical management (including bracing and placebo treatment). Two recent meta-analyses identified 13 RCTs published by January 2019 and 14 RCTs by July 2020, reaching different conclusions.
In 2019, Lou et al. concluded that percutaneous vertebroplasty was effective and safe only in patients with acute low-energy vertebral compression fractures associated with persistent and severe pain. In contrast, Lainez Ramos-Bossini et al. concluded in 2020 that vertebroplasty offered significant benefits compared with non-surgical treatment, including short-term pain relief and improved quality of life. However, these benefits appeared more limited when vertebroplasty was compared with placebo treatment.
The conclusion of the Cochrane review published by Buchbinder et al. in 2018 remains relevant today: "Based on high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty in the routine management of acute or subacute osteoporotic vertebral fractures." .
Furthermore, recent studies involving large patient cohorts have reported a significant rate of complications associated with percutaneous vertebroplasty. Among 1,932 patients, 166 (8.6%) experienced a complication, including 53 minor complications (2.7%) and 95 major complications (4.9%) . Patient selection appears to play a crucial role in the occurrence of complications, as suggested by Scheyerer et al. in a recent literature review .
The authors identified both non-modifiable and modifiable risk factors for perioperative and postoperative complications, including: age \>90 years, male sex, low level of daily activity, partial or complete dependency, hospitalization, high American Society of Anesthesiologists (ASA) classification, Parkinson's disease, chronic obstructive pulmonary disease (COPD), arterial hypertension, renal failure, liver failure, coagulopathies, chronic steroid use, preoperative sepsis, and hypoalbuminemia (\<3.5 g/dL) .
Simple preoperative markers, such as serum albumin levels, should therefore be considered when deciding whether vertebroplasty is appropriate for the treatment of low-energy vertebral compression fractures.
To improve the clarity and standardization of the management of patients presenting with low-energy vertebral compression fractures ("crush" fractures), we developed a clinical decision tree based on patient age, MRI findings, pain severity assessed using a Visual Analog Scale (VAS), and the extent of radiological deformity.
THE AIME OF THE STUDY IS : To 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) at Grenoble Alpes University Hospital between January 1, 2022, and March 31, 2025.
Design of the study :Single-center prospective observational cohort study with no control group.
Primary outcome measures
- 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) [Time frame: 1 year]
Secondary outcome measures (11)
- Assessment of radiological deformity. [Time frame: 1 year]
- Assessment of clinical outcomes [Time frame: 1 year]
- Assessment of clinical outcomes [Time frame: 1 year]
- Assessment of clinical outcomes [Time frame: 1 year]
- Assessment of clinical outcomes [Time frame: 1 year]
- Assessment of vertebroplasty cement filling quality [Time frame: 1 year]
- Assessment of fracture healing and associated factors [Time frame: 1 year]
- Assessment of fracture healing and associated factors [Time frame: 1 year]
- Assessment of fracture healing and associated factors [Time frame: 1 year]
- Assessment of complications [Time frame: 1 year]
- Assessment of treatment timelines [Time frame: 1 year]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Grenoble Alpes university Hospital — La Tronche
Identifiers
NCT: NCT07706439 · 38RC26.0185