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Thoracolumbar Low-energy Vertebral Compression FracturesPALMTREENCT07706439

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

An observational study of Thoracolumbar Low-energy Vertebral Compression Fractures, run by University Hospital, Grenoble at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
How many people
400 participants
Where
1 siteFrance
Study dates
15 Jul 2026to 15 Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehdi BOUDISSA, Pr contact

0476763275

mboudissa@chu-grenoble.fr

Sarah KASSAR-UNEISI, Pharm D contact

0476767524

suneisi@chu-grenoble.fr

France1 site
  • Grenoble Alpes university Hospital

    La Tronche, 38700

    Mehdi PI BOUDISSA, Pr, 0476763275, mboudissa@chu-grenoble.fr

    Sarah PI KASSAR-UNEISI, Pharm D, 0476767524, suneisi@chu-grenoble.fr

Other trials in France

About this study

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (11)
  1. 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

    Measured: 1 year

  2. Assessment of clinical outcomes

    EVA -pain score

    Measured: 1 year

  3. Assessment of clinical outcomes

    quality of life EQ5D 3 L

    Measured: 1 year

  4. Assessment of clinical outcomes

    Mobility -Parker Mobility Score

    Measured: 1 year

  5. Assessment of clinical outcomes

    Analysis of risk factors for failure of conservative treatment

    Measured: 1 year

  6. Assessment of vertebroplasty cement filling quality

    (Garnier classification)

    Measured: 1 year

  7. 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)

    Measured: 1 year

  8. 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.

    Measured: 1 year

  9. 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.

    Measured: 1 year

  10. 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).

    Measured: 1 year

  11. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07706439
Sponsor's protocol ID
38RC26.0185
Acronym
PALMTREE
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
17 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracolumbar Low-energy Vertebral Compression Fractures, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehdi BOUDISSA, Pr (0476763275, mboudissa@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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