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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracolumbar Low-energy Vertebral Compression Fractures

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Mehdi BOUDISSA, Pr; Phone Number: 0476763275; Email: mboudissa@chu-grenoble.fr
• Study Contact Backup: Name: Sarah KASSAR-UNEISI, Pharm D; Phone Number: 0476767524; Email: suneisi@chu-grenoble.fr

Study Locations

• France
  • La Tronche, France, 38700
    • Grenoble Alpes university Hospital
    • Principal Investigator: Mehdi BOUDISSA, Pr
    • Contact: Sarah PI KASSAR-UNEISI, Pharm D; Phone Number: 0476767524; Email: suneisi@chu-grenoble.fr
    • Contact: Mehdi PI BOUDISSA, Pr; Phone Number: 0476763275; Email: mboudissa@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

In this study, all patients treated for one or more low-energy vertebral compression fractures (LEVCFs) in the Department of Orthopedic Surgery and Traumatology at Grenoble Alpes University Hospital, according to the clinical decision tree, between January 1, 2022, and March 31, 2025, will be eligible for inclusion.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of radiological deformity.	Assessment of radiological deformity (vertebral kyphosis [VK], regional kyphosis [RK], and spinal canal narrowing) in patients managed according to the clinical decision tree	1 year
Assessment of clinical outcomes	EVA -pain score	1 year
Assessment of clinical outcomes	quality of life EQ5D 3 L	1 year
Assessment of clinical outcomes	Mobility -Parker Mobility Score	1 year
Assessment of clinical outcomes	Analysis of risk factors for failure of conservative treatment	1 year
Assessment of vertebroplasty cement filling quality	(Garnier classification)	1 year
Assessment of fracture healing and associated factors	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)	1 year
Assessment of fracture healing and associated factors	Assessment of the effect of calcium and vitamin D supplementation on fracture healing and the rate of refracture or new fractures.	1 year
Assessment of fracture healing and associated factors	Assessment of the effect of osteoporosis treatment on fracture healing and the rate of refracture or new fractures.	1 year
Assessment of complications	Perioperative and postoperative complications, including cement leakage, secondary lumbar spinal canal stenosis, intravertebral cleft (Kümmell disease), adjacent vertebral fractures, and pseudarthrosis (nonunion).	1 year
Assessment of treatment timelines	ime intervals (in days) between fracture occurrence and MRI, between MRI and surgical consultation, and between fracture occurrence and definitive treatment.	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 38RC26.0185

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No