Degenerative Changes After Treatment of Thoracolumbar Junction Fractures
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorSklifosovsky Institute of Emergency Care
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsGroup A: Conservative Treatment Cohort
Group B: Surgical Treatment Cohort
Group C: Control Cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline CT to the last available follow-up CT, with a minimum interval of 1 yearSecondary outcomes
1
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.
Time frame
From baseline CT to the last available follow-up CT, with a minimum interval of 1 year2
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.
Time frame
From baseline CT to the last available follow-up CT, with a minimum interval of 1 year3
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.
Time frame
From baseline CT to the last available follow-up CT, with a minimum interval of 1 year4
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.
Time frame
At the last available follow-up, at least 1 year after treatmentOther outcomes
1
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.
Time frame
From baseline imaging to the last available follow-up imaging, at least 1 year after treatment2
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.
Time frame
From baseline imaging to the last available follow-up imaging, at least 1 year after treatment3
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.
Time frame
At baseline imaging and, when available, at follow-up imaging up to the last available follow-up, at least 1 year after treatment4
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.
Time frame
Postoperative CT within 14 days after surgery and follow-up CT at 12 months after surgery.Sponsors and contacts
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Source ClinicalTrials.gov
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