Thoracic Spine FractureNCT06059820
Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological Deficit
An observational study of Thoracic Spine Fracture and Lumbar; Spine, Fracture, run by Sklifosovsky Institute of Emergency Care at 2 sites in Russia.
Trial summary
The goal of this observational study is to compare the long-term clinical outcomes of two treatment methods (conservative therapy and surgical treatment) in patients with fractures of the thoracic and lumbar spine without neurological deficit Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Spine Fracture, Lumbar; Spine, Fracture, Thoracolumbar Burst Fracture
- What is being tested?
- rehabilitation treatment and Spine fusion
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Nov 2023to 29 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants in the study are patients with spinal fractures who arrived through the emergency medical services and were urgently admitted to the hospital.
Who may be able to join
- Patients aged 18 to 65 years.
- Isolated fracture of a single thoracic or lumbar vertebra, classified as type A2 or A3 according to the AOSpine classification.
- Absence of clinical evidence of nerve root or spinal cord compression at the injury level.
- Degree of spinal canal space narrowing less than 50% based on CT scans.
- Informed consent to participate in the study.
Who cannot join
- Sagittal imbalance (Type 4 by C. Barrey).
- Vertebral bone density at the injury level less than 100 HU or osteoporosis exceeding grade 3 in vertebral bodies, pelvic bones, and limbs.
- Previous spinal surgeries.
- Anesthesia risk of 4 or 5 according to ASA.
- Acute exacerbation and decompensation of somatic diseases.
- Malignant tumors at any site.
Show all 21Show fewer
- Systemic connective tissue disorders.
- Cognitive impairments hindering patient communication.
- Floating and mural thrombosis, regardless of location.
- Newly identified and uncorrectable cardiac rhythm disorders.
- Dizziness.
- Consequences of a previous acute cerebrovascular event.
- Pregnancy at any stage.
- Acute infectious diseases.
- History of fractures of the pelvis, lower limbs, or vertebral bodies.
- Congenital spinal and limb disorders.
- Any conditions contraindicating physiotherapeutic procedures.
- Patient refusal to participate in the study.
- Inability to participate in follow-up examinations for one year after the injury.
- Participation in other clinical trials.
- Absence of a signed informed voluntary consent for medical interventions and processing of personal data or personal data processing.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Sklifosovsky Research Institute for Emergency Medicine
Moscow, 107045
Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine
Moscow, 111674
About this study
Official title: Prospective Cohort Study of the Effectiveness of Conservative Treatment in Patients With AOSpine Type A2 and A3 Fractures of the Thoracic and Lumbar Spine Without Neurological Deficit
The goal of this observational study is to compare the long-term clinical outcomes of two treatment methods (conservative therapy and surgical treatment) in patients with fractures of the thoracic and lumbar spine without neurological deficit
Read the detailed description
The main objectives of the upcoming study include:
- to conduct a retrospective analysis of the surgical treatment outcomes in patients with thoracic or lumbar vertebral fractures;
- to assess the immediate and long-term outcomes of conservative therapy in patients with thoracic or lumbar vertebral injuries;
- to evaluate the overall cost of surgical and conservative treatment one year post-discharge, as well as the duration of disability in patients with thoracic or lumbar vertebral fractures;
- to compare the results of surgical and conservative treatment methods in patients with thoracic or lumbar vertebral fractures.
The research focus will be on patients diagnosed with uncomplicated fractures of the thoracic and lumbar spine, classified as type A2 and A3 according to the AOSpine classification.
Two patient groups will be formed:
The main group (prospective) will consist of patients who underwent conservative therapy. The expected number of observations in the main group will be 40 patients.
The control group (historical control) will be comprised of 40 patients who underwent surgery previously at the Sklifosovsky Research Institute for Emergency Medicine.
The first stage of conservative therapy will be administered within 7 days at the departments of the Sklifosovsky Research Institute for Emergency Medicine. Subsequently, the patient will be transferred to a rehabilitation center for the second stage of conservative treatment at Branch No. 3 of the State Autonomous Healthcare Institution "Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine". The third stage of medical rehabilitation will be carried out at outpatient healthcare facilities based on the patient's place of residence.
The study will be considered complete when the data from the final examination of at least 50 patients in each group have been analyzed.
- Conditions
- Thoracic Spine Fracture, Lumbar; Spine, Fracture, Thoracolumbar Burst Fracture, Fracture of Spine, Level Unspecified, Spine Fusion, Spine Fracture
- Being tested
- rehabilitation treatment, Spine fusion
- Keywords
- Thoracic Spine Fracture, Lumbar Spine Fracture, thoracolumbar burst, Spine fusion, conservative treatment for spine fracture
- Medical subject headings
- Fractures, Bone, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation treatmentOther
3-month immobilization period, hyperextension braces for specific fractures, therapeutic exercises, and gradual activity restoration.
Spine fusionProcedure or surgery
Pedicle screw fixation or fusion; anterior plate fusion
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment group | The main group (prospective) will consist of patients who received conservative therapy. The expected number of observations in the main group will be 50 patients. Receives: Other: rehabilitation treatment | |
| Surgical treatment group | The control group (historical control) will be comprised of 50 patients who underwent surgery previously at the Sklifosovsky Research Institute for Emergency Medicine. Receives: Procedure: Spine fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
This questionnaire allows for a precise numeric assessment of the extent to which an individual's daily functioning is affected by back pain and objectively demonstrates the clinical outcome of the provided treatment. The scale will be applied at all stages of the study, starting from the initial examination and concluding with the follow-up examination one year after intervention. The questionnaire consists of 10 sections, each containing 6 statements. Depending on the response, a score from 0 to 5 is assigned. The maximum total score is 50. Subsequently, the scores are converted into percentages, ranging from 0 to 100%. If one of the sections is not applicable or omitted for ethical reasons, the sum of scores from the remaining 9 sections is divided by 45 to calculate the percentage.
Measured: admission, 3, 6 and 12 months
Secondary outcomes (5)
The SF-36 v.1 (Standard Form)
This questionnaire allows for a comprehensive assessment of the quality of life. The questionnaire consists of 36 questions grouped into 8 scales, evaluating physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Each scale has a maximum score of 100 points.
Measured: admission, 3, 6 and 12 months
EQ-5D-5L
This scale is similar to the SF-36 but provides a less detailed assessment of the social adaptation of patients and their emotional well-being. Nevertheless, this questionnaire is frequently used in prospective international research studies. Therefore, we consider it practical to use it to preserve the option for comparative analysis of our results with literature data. The questionnaire consists of 5 sections (mobility, self-care, usual activities, pain, anxiety), each with three statements, and a visual analogue scale EQ-VAS. The results can be converted into a single numerical value (index) adjusted for the patient's region of residence. Currently, there is no complete set of values to calculate this index for the Russian Federation, so in the initial stages, simple comparison of specific numerical values for each parameter will be used. When the technical capability becomes available, the index will be calculated at the end of the study.
Measured: admission, 3, 6 and 12 months
ASA
This classification categorizes patients into 5 classes based on the presence of comorbid conditions (Class I - healthy patient, Class V - moribund patient).
Measured: admission
Rivermead Mobility Index
The Rivermead Mobility Index (RMI) is a tool used to assess the mobility of patients, particularly after injuries or conditions such as stroke. This index is designed to measure a patient's ability to perform various motor tasks and includes an evaluation of aspects such as getting out of bed, moving around a room, descending stairs, and other mobility skills.
The Rivermead Mobility Index consists of several questions and items, each of which is assigned a specific score. All scores are then summed to determine the overall mobility index. This tool can be used for both medical and research purposes to assess patients' physical function and mobility.
Measured: 1, 3, 6 and 12 months
Lovett's muscle testing
Lovett's method is a clinical technique to assess erector spinae muscle strength. It involves having the patient perform specific movements or resist against applied force. This evaluates muscle strength and functional status. It's used in medical and physical therapy assessments for the lower back.
Measured: 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Oct 2024
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Spine FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sklifosovsky Institute of Emergency Care
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ivan Lvov, MD, PhD, Sklifosovsky Institute of Emergency Care
- Investigators
- Andrey Grin, MD, PhD, Study chair, Sklifosovsky Research Institute for Emergency MedicineAleksandr Talypov, MD, PhD, Study director, Sklifosovsky Research Institute for Emergency MedicineVasiliy Karanadze, MD, PhD, Principal investigator, Sklifosovsky Research Institute for Emergency MedicineIvan Lvov, MD, PhD, Principal investigator, Sklifosovsky Research Institute for Emergency MedicineAnton Kordonskiy, MD, PhD, Principal investigator, Sklifosovsky Research Institute for Emergency MedicineIren Pogonchenkova, MD, PhD, Study chair, Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059820
- Sponsor's protocol ID
- 1-28-08/2023
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the obtained data will be stored in the data centre of the Sklifosovsky Research Institute for Emergency Medicine. These data will be unavailable to all parties until the final analysis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of the Effectiveness of Conservative Treatment in Patients With AOSpine Type A2 and A3 Fractures of the Thoracic and Lumbar Spine Without Neurological Deficit
- ClinicalTrials.gov ID
- NCT06059820
- Acronym / sponsor ID
- 1-28-08/2023
- Conditions
- Thoracic Spine Fracture, Lumbar; Spine, Fracture, Thoracolumbar Burst Fracture, Fracture of Spine, Level Unspecified, Spine Fusion, Spine Fracture
- Keywords
- Thoracic Spine Fracture, Lumbar Spine Fracture, thoracolumbar burst, Spine fusion, conservative treatment for spine fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sklifosovsky Institute of Emergency CareOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to compare the long-term clinical outcomes of two treatment methods (conservative therapy and surgical treatment) in patients with fractures of the thoracic and lumbar spine without neurological deficit
Detailed description
The main objectives of the upcoming study include:
- to conduct a retrospective analysis of the surgical treatment outcomes in patients with thoracic or lumbar vertebral fractures;
- to assess the immediate and long-term outcomes of conservative therapy in patients with thoracic or lumbar vertebral injuries;
- to evaluate the overall cost of surgical and conservative treatment one year post-discharge, as well as the duration of disability in patients with thoracic or lumbar vertebral fractures;
- to compare the results of surgical and conservative treatment methods in patients with thoracic or lumbar vertebral fractures.
The research focus will be on patients diagnosed with uncomplicated fractures of the thoracic and lumbar spine, classified as type A2 and A3 according to the AOSpine classification.
Two patient groups will be formed:
The main group (prospective) will consist of patients who underwent conservative therapy. The expected number of observations in the main group will be 40 patients.
The control group (historical control) will be comprised of 40 patients who underwent surgery previously at the Sklifosovsky Research Institute for Emergency Medicine.
The first stage of conservative therapy will be administered within 7 days at the departments of the Sklifosovsky Research Institute for Emergency Medicine. Subsequently, the patient will be transferred to a rehabilitation center for the second stage of conservative treatment at Branch No. 3 of the State Autonomous Healthcare Institution "Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine". The third stage of medical rehabilitation will be carried out at outpatient healthcare facilities based on the patient's place of residence.
The study will be considered complete when the data from the final examination of at least 50 patients in each group have been analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment group | – | Other: rehabilitation treatmentThe main group (prospective) will consist of patients who received conservative therapy. The expected number of observations in the main group will be 50 patients. |
| Surgical treatment group | – | Procedure: Spine fusionThe control group (historical control) will be comprised of 50 patients who underwent surgery previously at the Sklifosovsky Research Institute for Emergency Medicine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants in the study are patients with spinal fractures who arrived through the emergency medical services and were urgently admitted to the hospital.
Key inclusion criteria (5 listed)
- Patients aged 18 to 65 years.
- Isolated fracture of a single thoracic or lumbar vertebra, classified as type A2 or A3 according to the AOSpine classification.
- Absence of clinical evidence of nerve root or spinal cord compression at the injury level.
- Degree of spinal canal space narrowing less than 50% based on CT scans.
- Informed consent to participate in the study.
Key exclusion criteria (21 listed)
- Sagittal imbalance (Type 4 by C. Barrey).
- Vertebral bone density at the injury level less than 100 HU or osteoporosis exceeding grade 3 in vertebral bodies, pelvic bones, and limbs.
- Previous spinal surgeries.
- Anesthesia risk of 4 or 5 according to ASA.
- Acute exacerbation and decompensation of somatic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitation treatment3-month immobilization period, hyperextension braces for specific fractures, therapeutic exercises, and gradual activity restoration. | Other | Conservative treatment group |
| Spine fusionPedicle screw fixation or fusion; anterior plate fusion | Procedure or surgery | Surgical treatment group |
Primary outcome
Oswestry Disability Index
Time frame: admission, 3, 6 and 12 months
This questionnaire allows for a precise numeric assessment of the extent to which an individual's daily functioning is affected by back pain and objectively demonstrates the clinical outcome of the provided treatment. The scale will be applied at all stages of the study, starting from the initial examination and concluding with the follow-up examination one year after intervention. The questionnaire consists of 10 sections, each containing 6 statements. Depending on the response, a score from 0 to 5 is assigned. The maximum total score is 50. Subsequently, the scores are converted into percentages, ranging from 0 to 100%. If one of the sections is not applicable or omitted for ethical reasons, the sum of scores from the remaining 9 sections is divided by 45 to calculate the percentage.
5 secondary outcomes
The SF-36 v.1 (Standard Form)
Time frame: admission, 3, 6 and 12 months
EQ-5D-5L
Time frame: admission, 3, 6 and 12 months
ASA
Time frame: admission
Rivermead Mobility Index
Time frame: 1, 3, 6 and 12 months
Lovett's muscle testing
Time frame: 1, 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. All the obtained data will be stored in the data centre of the Sklifosovsky Research Institute for Emergency Medicine. These data will be unavailable to all parties until the final analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey Grin, MD, PhD study chair
Sklifosovsky Research Institute for Emergency Medicine
Aleksandr Talypov, MD, PhD study director
Sklifosovsky Research Institute for Emergency Medicine
Vasiliy Karanadze, MD, PhD principal investigator
Sklifosovsky Research Institute for Emergency Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Spine Fracture and Lumbar; Spine, Fracture, run by Sklifosovsky Institute of Emergency Care at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: admission, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.