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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
The main objectives of the upcoming study include:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rehabilitation treatment | Other | 3-month immobilization period, hyperextension braces for specific fractures, therapeutic exercises, and gradual activity restoration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | admission, 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | admission, 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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All participants in the study are patients with spinal fractures who arrived through the emergency medical services and were urgently admitted to the hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Andrey Grin, MD, PhD | Sklifosovsky Research Institute for Emergency Medicine | Study Chair |
| Aleksandr Talypov, MD, PhD | Sklifosovsky Research Institute for Emergency Medicine | Study Director |
| Vasiliy Karanadze, MD, PhD | Sklifosovsky Research Institute for Emergency Medicine | Principal Investigator |
| Ivan Lvov, MD, PhD | Sklifosovsky Research Institute for Emergency Medicine | Principal Investigator |
| Anton Kordonskiy, MD, PhD | Sklifosovsky Research Institute for Emergency Medicine | Principal Investigator |
| Iren Pogonchenkova, MD, PhD | Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sklifosovsky Research Institute for Emergency Medicine | Moscow | 107045 | Russia | |||
| Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine |
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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| Spine fusion | Procedure | Pedicle screw fixation or fusion; anterior plate fusion |
|
| 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. | 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). | 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. | 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. | 1, 3, 6 and 12 months |
| Moscow |
| 111674 |
| Russia |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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