Grenoble Alpes university Hospital
La Tronche, 38700, France
Location contact
Mehdi BOUDISSA, Pr
PRINCIPAL_INVESTIGATOR
Mehdi PI BOUDISSA, Pr
CONTACT
Sarah PI KASSAR-UNEISI, Pharm D
CONTACT
NCT Number: NCT07706439
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.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Observational
La Tronche, 38700, France
Mehdi BOUDISSA, Pr
PRINCIPAL_INVESTIGATOR
Mehdi PI BOUDISSA, Pr
CONTACT
Sarah PI KASSAR-UNEISI, Pharm D
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 1 year
Assessment of radiological deformity (vertebral kyphosis [VK], regional kyphosis [RK], and spinal canal narrowing) in patients managed according to the clinical decision tree
Time frame: 1 year
EVA -pain score
Time frame: 1 year
quality of life EQ5D 3 L
Time frame: 1 year
Mobility -Parker Mobility Score
Time frame: 1 year
Analysis of risk factors for failure of conservative treatment
Time frame: 1 year
(Garnier classification)
Time frame: 1 year
Evaluation of time to fracture healing, comparing conservative versus surgical treatment (measured in days; for surgical treatment, time is calculated from the date of surgery)
Time frame: 1 year
Assessment of the effect of calcium and vitamin D supplementation on fracture healing and the rate of refracture or new fractures.
Time frame: 1 year
Assessment of the effect of osteoporosis treatment on fracture healing and the rate of refracture or new fractures.
Time frame: 1 year
Perioperative and postoperative complications, including cement leakage, secondary lumbar spinal canal stenosis, intravertebral cleft (Kümmell disease), adjacent vertebral fractures, and pseudarthrosis (nonunion).
Time frame: 1 year
ime intervals (in days) between fracture occurrence and MRI, between MRI and surgical consultation, and between fracture occurrence and definitive treatment.
Contact information is provided by the study sponsor or research team.
Mehdi BOUDISSA, Pr
CONTACT
Sarah KASSAR-UNEISI, Pharm D
CONTACT
University Hospital, Grenoble
Other
Acronym: PALMTREE
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