Clinical trial NCT06059820: Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological Deficit
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Sklifosovsky Institute of Emergency Care
Sponsor class: OTHER_GOV
First posted: 2023-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: admission, 3, 6 and 12 months
Secondary outcomes:
measure: The SF-36 v.1 (Standard Form)
timeFrame: admission, 3, 6 and 12 months
measure: EQ-5D-5L
timeFrame: admission, 3, 6 and 12 months
measure: ASA
timeFrame: admission
measure: Rivermead Mobility Index
timeFrame: 1, 3, 6 and 12 months
measure: Lovett's muscle testing
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sklifosovsky Research Institute for Emergency Medicine
city: Moscow
country: Russian Federation
facility: Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine
Study officials:
affiliation: Sklifosovsky Research Institute for Emergency Medicine
name: Andrey Grin, MD, PhD
role: STUDY_CHAIR
affiliation: Sklifosovsky Research Institute for Emergency Medicine
name: Aleksandr Talypov, MD, PhD
role: STUDY_DIRECTOR
affiliation: Sklifosovsky Research Institute for Emergency Medicine
name: Vasiliy Karanadze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sklifosovsky Research Institute for Emergency Medicine
name: Ivan Lvov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sklifosovsky Research Institute for Emergency Medicine
name: Anton Kordonskiy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine
name: Iren Pogonchenkova, MD, PhD
role: STUDY_CHAIR
References: