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NCT Number: NCT07672184

Degenerative Changes After Treatment of 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.

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Key information

Conditions

Thoracolumbar Spine Fracture Bone Diseases Facet Joint Degeneration Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sklifosovsky Research Institute for Emergency Medicine

Moscow, 129090, Russia

Location contact

Aleksandr Talypov, MD, PhD

SUB_INVESTIGATOR

Aleksandr Tupikin, MD

SUB_INVESTIGATOR

Andrey Grin, MD, PhD

PRINCIPAL_INVESTIGATOR

Anton Kordonsky, MD, PhD

SUB_INVESTIGATOR

Ivan Lvov, MD, PhD

SUB_INVESTIGATOR

Ksenia Dmitrenko, MD

SUB_INVESTIGATOR

Layla Khamidova, MD, PhD

SUB_INVESTIGATOR

Maria Nanoyan, MD

SUB_INVESTIGATOR

Mikhail Kucherov, MD

SUB_INVESTIGATOR

Olga Minkina, MD

SUB_INVESTIGATOR

Rinat Abdrafiev, MD

SUB_INVESTIGATOR

Roman Elokhovskiy, MD, PhD

SUB_INVESTIGATOR

Vasiliy Karanadze, MD, PhD

CONTACT

[email protected]

+7 903 565-68-30

Vasily Karandze, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Facet Joint Degeneration Grade on Computed Tomography

    Time frame: 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.

Secondary outcomes

  1. Change in Intervertebral Disc Degeneration and Ankylosis Grade on Computed Tomography

    Time frame: 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.

  2. Change in Facet Joint Space Width on Computed Tomography

    Time frame: 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.

  3. Change in Facet Joint Angle and Facet Tropism on Computed Tomography

    Time frame: 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.

  4. Radiological Treatment Result in the Fracture Cohorts

    Time frame: 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.

  5. Pain Intensity on the Visual Analog Scale

    Time frame: 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.

  6. Functional Disability on the Oswestry Disability Index

    Time frame: 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.

  7. Health-Related Quality of Life on the SF-36 Questionnaire

    Time frame: 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.

Other outcomes

  1. Change in Bisegmental Cobb Angle

    Time frame: 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.

  2. Change in Vertebral Body Height and Vertebral Body Index

    Time frame: 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.

  3. Spinal Canal Stenosis

    Time frame: 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.

  4. Pedicle Screw Position and Facet Joint Violation

    Time frame: 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.

  5. Implant-Related Complications

    Time frame: 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.

  6. Sagittal Balance Parameters

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan Lvov, MD, PhD

CONTACT

[email protected]

+34 654 902 306

Vasiliy Karanadze, MD, PhD

CONTACT

[email protected]

+7 903 565-68-30

Sponsors and collaborators

Lead sponsor

Sklifosovsky Institute of Emergency Care

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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