- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07645092
Vertebral Augmentation and Percutaneous Fixation for Thoracolumbar Burst Fractures Requiring Corpectomy (EXVERCOR)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Burst fractures account for approximately 17% of thoracolumbar fractures occurring after high-energy trauma. They are characterized by collapse of the anterior column, leading to loss of vertebral height and a local kyphotic deformity. Involvement of the middle column is a key factor in mechanical instability and largely explains the neurological risk, thus giving burst fractures a particular status among thoracolumbar injuries
In the 1990s, McCormack developed the Load Sharing Classification (LSC) to guide treatment strategy. A score below 7 supported isolated posterior fixation, whereas a score of 7 or higher led to the recommendation of a more invasive approach, including upfront corpectomy combined with supplementary anterior grafting to prevent early construct failure . Grobost demonstrated that corpectomies performed upfront yielded better functional outcomes than those performed secondarily in the context of pseudarthrosis . Although corpectomies provide reliable restoration of the anterior column, they are associated with significant morbidity, prompting the search for less invasive alternatives capable of restoring vertebral height and kyphosis while limiting complications.
Today, newer minimally invasive techniques allow reduction of vertebral height loss and local kyphosis while decreasing the mechanical load on posterior instrumentation . The systematic need for a major anterior procedure (grafting or corpectomy) may therefore be reconsidered. Among these techniques, vertebral expansion devices such as SpineJack have demonstrated the ability to effectively restore vertebral body height and maintain correction over time, particularly when combined with short posterior fixation.
Since 2005, publications on burst fractures have been predominantly limited to meta-analyses, with few new clinical series. Furthermore, available studies mainly focus on fractures of moderate severity, resulting in a lack of data on more severe fractures with an LSC score ≥ 7.
The aim of this study is to evaluate the clinical and radiological outcomes of patients treated at Grenoble Alpes University Hospital for thoracic and lumbar spine burst fractures with a Load Sharing Classification (LSC) score ≥7, managed with vertebral augmentation and percutaneous fixation.
Our hypothesis is that the combined use of percutaneous posterior fixation and anterior vertebral augmentation provides satisfactory clinical and radiological outcomes, thereby avoiding the need for corpectomy in thoracolumbar burst fractures (LSC ≥7).
DESIGN OF THE STUDY :Descriptive, single-center, observational cohort study, both retrospective and prospective, without a control group.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Mehdi BOUDISSA, Pr
- Telefonnummer: 0476763275
- E-mail: mboudissa@chu-grenoble.fr
Undersøgelse Kontakt Backup
- Navn: Sarah PI KASSAR-UNEISI, Pharm D
- Telefonnummer: 0476767524
- E-mail: suneisi@chu-grenoble.fr
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
In this study, all adult patients treated for thoracic and lumbar spine fractures with a Load Sharing Classification (LSC) score ≥ 7, who underwent posterior fixation (+1/-1 levels) combined with anterior vertebral augmentation, will be eligible for inclusion.
Epidemiological data, preoperative management, AO Spine classification [1], operative data, and radiological findings are collected and analyzed.
Data collection is performed using patients' medical records and during a follow-up telephone visit.
Beskrivelse
Inclusion Criteria:
- Adult patient at the time of the fracture.
- Patient who underwent posterior fixation (+1/-1 levels) combined with anterior vertebral augmentation:
Fracture with a Load Sharing Classification (LSC) score ≥ 7 Single vertebral level involved Percutaneous surgery
- Preoperative CT scans (thoracic and lumbar spine)
- Postoperative CT scans (thoracic and lumbar spine)
Exclusion Criteria:
- Persons deprived of liberty by judicial or administrative decision, or persons under legal protection measures.
- Non-inclusion criteria include:
Performance of a laminectomy Pathological fractures Fractures classified as type C or B2 according to the AO Spine classification Presence of severe scoliosis Neurological deficit More than one vertebral fracture
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate clinical and radiological outcomes of thoracolumbar burst fractures (LSC ≥7) treated with vertebral augmentation and percutaneous fixation.
Tidsramme: 1 year
|
Absence of the need for secondary corpectomy due to pseudarthrosis and/or fixation failure.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of the quality of radiological reduction
Tidsramme: 1 year
|
Radiological criteria: Fracture healing is assessed on standard radiographs based on cortical continuity, disappearance of fracture lines, maintenance of vertebral body height, absence of progression of kyphotic deformity, and absence of hardware failure.
Healing is classified as complete, partial, or absent.
|
1 year
|
|
Assessment of the quality of radiological reduction
Tidsramme: 1 year
|
Measurement of regional kyphosis, local kyphosis, and mean vertebral height preoperatively, postoperatively, and at 1-year follow-up.
|
1 year
|
|
Assessment of the quality of radiological reduction
Tidsramme: 1 year
|
AO Spine classification
|
1 year
|
|
Assessment of clinical outcomes
Tidsramme: 1 year
|
Clinical scores: ODI (Oswestry Disability Index)
|
1 year
|
|
Assessment of clinical outcomes
Tidsramme: 1 year
|
Clinical scores: VAS (Visual Analog Scale)
|
1 year
|
|
Assessment of complications
Tidsramme: 1 year
|
Complications: reoperation(s), infection, wound healing disorders, hardware failure, hardware-related discomfort and hardware removal, pseudarthrosis, and secondary collapse after hardware removal (loss of vertebral height or kyphosis >10°)
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-A00934-47
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Kliniske forsøg med Thoracolumbar Burst Fractures
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Uppsala UniversityKarolinska University Hospital; Oslo University Hospital; Helse Stavanger HF og andre samarbejdspartnereAktiv, ikke rekrutterende
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AO Innovation Translation CenterAO Foundation, AO SpineAfsluttetThoracolumbar burst frakturForenede Stater, Egypten, Australien, Canada, Grækenland, Indien, Holland, Rumænien, Spanien, Schweiz
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Jinling Hospital, ChinaNational Natural Science Foundation of ChinaUkendtThoracolumbar burst frakturKina
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Sklifosovsky Institute of Emergency CareAfsluttetSpine Fusion | Rygsøjlebrud | Fraktur af brystryggen | Thoracolumbar burst fraktur | Lænde; Rygsøjle, Fraktur | Brud på rygsøjlen, niveau uspecificeretRusland
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Ascension South East MichiganRekruttering
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Medical University InnsbruckIkke rekrutterer endnuBrud hos ældre | Thoracolumbar
-
Rush University Medical CenterRekrutteringÅbn posterior Thoracolumbar Spinal Fusion ProcedureForenede Stater
-
Assiut UniversityUkendt
-
Amasya UniversityIkke rekrutterer endnuTotal intravenøs anæstesi | Bispektral indeksovervågning | Burst-undertrykkelseTyrkiet (Türkiye)
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Indonesia UniversityAfsluttetTranskraniel magnetisk stimulering | Metamfetaminbrugsforstyrrelse | Theta burst -stimuleringIndonesien