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Degenerative Changes After Treatment of Thoracolumbar Junction Fractures

27 juni 2026 bijgewerkt door: Ivan Lvov, MD, PhD, Sklifosovsky Institute of Emergency Care

Degenerative Changes in Injured and Adjacent Spinal Motion Segments After Conservative and Surgical Treatment of AOSpine Type A2, A3, and A4 Thoracolumbar Junction Fractures

This observational study will evaluate how degenerative changes in the facet joints and intervertebral discs develop over time after treatment of AOSpine type A2, A3, and A4 fractures of the thoracolumbar junction. Patients treated conservatively and patients treated surgically will be compared with each other and with a control group of patients who underwent repeated computed tomography examinations for reasons unrelated to traumatic or degenerative spinal disease.

The study will assess computed tomography findings at the injured spinal motion segment and adjacent segments, including facet joint degeneration, intervertebral disc degeneration, signs of ankylosis, facet joint space parameters, and facet joint angle. Clinical outcomes in the fracture cohort will be evaluated using pain scores and validated questionnaires. The purpose of the study is to identify factors associated with progression of degenerative changes after thoracolumbar junction fractures and to clarify whether treatment method is associated with long-term degeneration of the injured and adjacent spinal motion segments.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

This is an ambispective longitudinal comparative cohort study designed to evaluate the development and progression of degenerative changes in the facet joints and intervertebral discs after treatment of traumatic fractures of the thoracolumbar junction.

The fracture cohort will include adult patients with AOSpine type A2, A3, or A4 fractures of the thoracolumbar junction who were treated at the N.V. Sklifosovsky Research Institute for Emergency Medicine. Patients will be analyzed according to treatment strategy, including conservative treatment and surgical treatment without disruption of the posterior supporting column. Surgical treatment may include anterior fusion, transpedicular fixation, or combined procedures without direct posterior decompression. Retrospective medical records and imaging data will be reviewed, and available patients will be invited for follow-up clinical and radiological assessment.

A control cohort will include adult patients who underwent at least two computed tomography examinations covering the thoracolumbar junction for conditions unrelated to traumatic or degenerative spinal disease. The interval between computed tomography examinations must be at least 1 year.

Radiological assessment will be performed using computed tomography. The analysis will include the injured spinal motion segment and adjacent segments. Imaging parameters will include facet joint degeneration according to Pathria criteria, intervertebral disc degeneration with assessment of ankylosis, facet joint space width, facet joint angle, facet tropism, fracture type according to the AOSpine classification, bisegmental Cobb angle, anterior vertebral body height, vertebral body index, relative spinal canal stenosis, pedicle screw position, facet joint violation by pedicle screws, radiological evidence of fracture healing or pseudarthrosis, implant-associated complications, and sagittal balance, as applicable.

Clinical outcomes in the fracture cohort will be assessed using the Visual Analog Scale for pain, the Oswestry Disability Index, and the SF-36 quality-of-life questionnaire.

The primary purpose of the study is to compare the longitudinal dynamics of degenerative changes in the facet joints and intervertebral discs between patients treated conservatively, patients treated surgically, and patients without traumatic or degenerative thoracolumbar junction disease. The study will also explore clinical and radiological factors associated with progression of degeneration at the injured and adjacent spinal motion segments.

Studietype

Observationeel

Inschrijving (Geschat)

150

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Rusland
      • Moscow, Rusland, 129090
        • Sklifosovsky Research Institute for Emergency Medicine
        • Hoofdonderzoeker:
          • Andrey Grin, MD, PhD
        • Onderonderzoeker:
          • Aleksandr Talypov, MD, PhD
        • Onderonderzoeker:
          • Anton Kordonsky, MD, PhD
        • Onderonderzoeker:
          • Vasily Karandze, MD, PhD
        • Onderonderzoeker:
          • Ivan Lvov, MD, PhD
        • Onderonderzoeker:
          • Mikhail Kucherov, MD
        • Onderonderzoeker:
          • Rinat Abdrafiev, MD
        • Onderonderzoeker:
          • Aleksandr Tupikin, MD
        • Onderonderzoeker:
          • Ksenia Dmitrenko, MD
        • Onderonderzoeker:
          • Maria Nanoyan, MD
        • Onderonderzoeker:
          • Olga Minkina, MD
        • Contact:
        • Onderonderzoeker:
          • Layla Khamidova, MD, PhD
        • Onderonderzoeker:
          • Roman Elokhovskiy, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population will include adults aged 18 to 50 years enrolled in three cohorts. The conservative treatment cohort will include patients with acute or subacute AOSpine type A2, A3, or A4 thoracolumbar junction fractures treated nonoperatively. The surgical treatment cohort will include patients with the same fracture types treated surgically without disruption of the posterior supporting column. The control cohort will include adults without traumatic or degenerative thoracolumbar junction disease who underwent at least two computed tomography examinations covering Th9-L4 for unrelated clinical indications, with an interval of at least 1 year between examinations.

Beschrijving

Inclusion Criteria:

Conservative Treatment Cohort:

  • Age 18 to 50 years.
  • Acute or subacute traumatic fracture of the thoracolumbar junction at the start of treatment.
  • AOSpine type A2, A3, or A4 fracture.
  • No clinical evidence of nerve root or spinal cord compression at the injured level.
  • Conservative treatment of the thoracolumbar junction fracture.
  • Minimum follow-up period of 1 year.
  • Written informed consent for prospective follow-up or additional study procedures, when applicable.

Surgical Treatment Cohort:

  • Age 18 to 50 years.
  • Acute or subacute traumatic fracture of the thoracolumbar junction at the start of treatment.
  • AOSpine type A2, A3, or A4 fracture.
  • No clinical evidence of nerve root or spinal cord compression at the injured level.
  • Surgical treatment performed without disruption of the posterior supporting column.
  • Surgical treatment may include anterior fusion, transpedicular fixation, or combined surgery without direct posterior decompression.
  • Minimum follow-up period of 1 year.
  • Written informed consent for prospective follow-up or additional study procedures, when applicable.

Control Cohort:

  • Age 18 to 50 years.
  • At least two computed tomography examinations covering the Th9-L4 vertebral levels.
  • Interval of at least 1 year between computed tomography examinations.
  • Computed tomography performed for reasons unrelated to traumatic or degenerative thoracolumbar junction disease.
  • No imaging artifacts at the spinal levels included in the study assessment.

Exclusion Criteria:

Conservative Treatment Cohort:

  • Severe combined trauma.
  • Severe concomitant disease.
  • Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.
  • Verified osteoporosis.
  • Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.
  • Previous spine surgery.
  • American Society of Anesthesiologists physical status class 4 or 5.
  • Participation in another clinical study related to treatment of spinal disease or spinal trauma.
  • Withdrawal of informed consent, when applicable.

Surgical Treatment Cohort:

  • Severe combined trauma.
  • Severe concomitant disease.
  • Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.
  • Verified osteoporosis.
  • Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.
  • Previous spine surgery.
  • Direct posterior decompression or other surgery disrupting the posterior supporting column.
  • American Society of Anesthesiologists physical status class 4 or 5.
  • Participation in another clinical study related to treatment of spinal disease or spinal trauma.
  • Withdrawal of informed consent, when applicable.

Control Cohort:

  • Complicated fracture of any spinal region.
  • Combined trauma or severe concomitant disease limiting patient mobility.
  • Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.
  • Grade 4 facet joint degeneration according to the Pathria classification at the studied levels.
  • Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.
  • Previous spine surgery, including surgery without implants.
  • Spinal fracture with injury to the posterior supporting column.
  • Participation in another clinical study related to treatment of spinal disease or spinal trauma.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Conservative Treatment Cohort
Adult patients with acute or subacute AOSpine type A2, A3, or A4 fractures of the thoracolumbar junction treated conservatively. Patients will have no clinical evidence of nerve root or spinal cord compression at the injured level and will have a minimum follow-up period of 1 year. Clinical records, computed tomography imaging, and follow-up clinical outcomes will be analyzed.
Surgical Treatment Cohort
Adult patients with acute or subacute AOSpine type A2, A3, or A4 fractures of the thoracolumbar junction treated surgically without disruption of the posterior supporting column. Surgical treatment may include anterior fusion, transpedicular fixation, or combined procedures without direct posterior decompression. Clinical records, computed tomography imaging, implant-related findings, and follow-up clinical outcomes will be analyzed.
Control Cohort
Adult patients without traumatic or degenerative thoracolumbar junction disease who underwent at least two computed tomography examinations covering the thoracolumbar junction for reasons unrelated to spinal trauma or degeneration. The interval between computed tomography examinations will be at least 1 year. Imaging data will be used to assess the natural dynamics of facet joint and intervertebral disc degenerative changes.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Facet Joint Degeneration Grade on Computed Tomography
Tijdsspanne: From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Change in the degree of facet joint degeneration from baseline to follow-up, assessed on computed tomography using the Pathria grading system. Facet joints will be evaluated at the injured or treated spinal motion segment and adjacent segments in the fracture cohorts, and at corresponding thoracolumbar junction segments in the control cohort.
From baseline CT to the last available follow-up CT, with a minimum interval of 1 year

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Intervertebral Disc Degeneration and Ankylosis Grade on Computed Tomography
Tijdsspanne: From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Change in intervertebral disc degeneration from baseline to follow-up, assessed on computed tomography with specific evaluation of osteophyte formation and ankylosis. Intervertebral discs will be evaluated at the injured or treated spinal motion segment and adjacent segments in the fracture cohorts, and at corresponding thoracolumbar junction segments in the control cohort.
From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Change in Facet Joint Space Width on Computed Tomography
Tijdsspanne: From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Change in average, minimum, and maximum facet joint space width measured on computed tomography in millimeters. Measurements will be performed for facet joints without advanced ankylosis when applicable.
From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Change in Facet Joint Angle and Facet Tropism on Computed Tomography
Tijdsspanne: From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Change in facet joint angle measured on axial computed tomography images. Facet tropism will be assessed as the difference between the right and left facet joint angles when applicable.
From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Radiological Treatment Result in the Fracture Cohorts
Tijdsspanne: At the last available follow-up, at least 1 year after treatment
Radiological treatment result will be categorized as fracture healing or fusion, stable pseudarthrosis, or unstable pseudarthrosis with clinical and radiological signs of instability, based on follow-up imaging.
At the last available follow-up, at least 1 year after treatment
Pain Intensity on the Visual Analog Scale
Tijdsspanne: At the final clinical follow-up, at least 1 year after treatment
Pain intensity in the fracture cohorts will be assessed using the Visual Analog Scale, where higher scores indicate greater pain intensity.
At the final clinical follow-up, at least 1 year after treatment
Functional Disability on the Oswestry Disability Index
Tijdsspanne: At the final clinical follow-up, at least 1 year after treatment
Functional disability in the fracture cohorts will be assessed using the Oswestry Disability Index. Higher scores indicate greater disability.
At the final clinical follow-up, at least 1 year after treatment
Health-Related Quality of Life on the SF-36 Questionnaire
Tijdsspanne: At the final clinical follow-up, at least 1 year after treatment
Health-related quality of life in the fracture cohorts will be assessed using the SF-36 questionnaire. The questionnaire evaluates multiple domains of physical and mental health, with higher scores indicating better health-related quality of life.
At the final clinical follow-up, at least 1 year after treatment

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Bisegmental Cobb Angle
Tijdsspanne: From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
Change in the bisegmental Cobb angle related to the fractured vertebra, measured on computed tomography or radiographic images according to the study protocol. This parameter will be assessed in the fracture cohorts as a radiological measure of segmental kyphotic deformity.
From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
Change in Vertebral Body Height and Vertebral Body Index
Tijdsspanne: From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
Change in anterior vertebral body height and vertebral body index of the fractured vertebra, assessed on computed tomography or radiographic images. These parameters will be used to evaluate post-treatment vertebral body restoration, collapse, or progression of deformity in the fracture cohorts.
From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
Spinal Canal Stenosis
Tijdsspanne: At baseline imaging and, when available, at follow-up imaging up to the last available follow-up, at least 1 year after treatment
Relative spinal canal stenosis at the fractured level will be assessed on computed tomography by comparing the spinal canal area at the injured level with the canal area at adjacent intact levels. This parameter will be evaluated in the fracture cohorts.
At baseline imaging and, when available, at follow-up imaging up to the last available follow-up, at least 1 year after treatment
Pedicle Screw Position and Facet Joint Violation
Tijdsspanne: Postoperative CT within 14 days after surgery and follow-up CT at 12 months after surgery.
In surgically treated patients, pedicle screw position will be assessed according to the Gertzbein-Robbins classification. Facet joint violation by pedicle screws will be evaluated using cranio-caudal and medio-lateral screw position and screw head depression grades.
Postoperative CT within 14 days after surgery and follow-up CT at 12 months after surgery.
Implant-Related Complications
Tijdsspanne: From surgery to the last available follow-up, at least 1 year after treatment
Implant-associated complications in surgically treated patients will be recorded based on clinical records and follow-up imaging. These may include radiological or clinical evidence of fixation failure, implant loosening, implant malposition, or other implant-related adverse findings.
From surgery to the last available follow-up, at least 1 year after treatment
Sagittal Balance Parameters
Tijdsspanne: At the last available follow-up, at least 1 year after treatment
Sagittal balance will be assessed on available standing radiographs or other appropriate imaging studies according to the study protocol. This parameter will be evaluated in the fracture cohorts when imaging data are available.
At the last available follow-up, at least 1 year after treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sklifosovsky Institute of Emergency Care

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

16 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

27 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SKL06-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared. The study will use clinical records, imaging data, and questionnaire results, which may contain sensitive health information. Data obtained during the study will be stored at the N.V. Sklifosovsky Research Institute for Emergency Medicine. Study results will be reported in aggregate form in peer-reviewed publications and scientific presentations.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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