Degenerative Changes After Treatment of Thoracolumbar Junction Fractures

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intervertebral Disc Degeneration; Thoracolumbar Spine Fracture; Facet Joint Degeneration

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Ivan Lvov, MD, PhD; Phone Number: +34 654 902 306; Email: dr.speleolog@gmail.com
• Study Contact Backup: Name: Vasiliy Karanadze, MD, PhD; Phone Number: +7 903 565-68-30; Email: karanadzevneuro@gmail.com

Study Locations

• Russia
  • Moscow, Russia, 129090
    • Sklifosovsky Research Institute for Emergency Medicine
    • Principal Investigator: Andrey Grin, MD, PhD
    • Sub-Investigator: Aleksandr Talypov, MD, PhD
    • Sub-Investigator: Anton Kordonsky, MD, PhD
    • Sub-Investigator: Vasily Karandze, MD, PhD
    • Sub-Investigator: Ivan Lvov, MD, PhD
    • Sub-Investigator: Mikhail Kucherov, MD
    • Sub-Investigator: Rinat Abdrafiev, MD
    • Sub-Investigator: Michael Kalandari, MD
    • Sub-Investigator: Aleksandr Tupikin, MD
    • Sub-Investigator: Ksenia Dmitrenko, MD
    • Sub-Investigator: Maria Nanoyan, MD
    • Sub-Investigator: Olga Minkina, MD
    • Contact: Vasiliy Karanadze, MD, PhD; Phone Number: +7 903 565-68-30; Email: karanadzevneuro@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Facet Joint Degeneration Grade on Computed Tomography	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intervertebral Disc Degeneration and Ankylosis Grade on Computed Tomography	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	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	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	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	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	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bisegmental Cobb Angle	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Sklifosovsky Institute of Emergency Care

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Computed Tomography; Intervertebral Disc Degeneration; Adjacent Segment Degeneration; Thoracolumbar Junction Fracture; AOSpine Classification; AOSpine Type A2 Fracture; AOSpine Type A3 Fracture; AOSpine Type A4 Fracture; Facet Joint Degeneration; Spinal Motion Segment
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: SKL06-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

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