Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06059820
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological Deficit
Sponsor:
Sklifosovsky Institute of Emergency Care
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: