Clinical Trials Logo
  1. Home
  2. Thoracic Spine Fracture
  3. NCT06059820

Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological Deficit

Spine Fusion Clinical Trial

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

Clinical 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06059820
Study type Observational
Source Sklifosovsky Institute of Emergency Care
Contact Vasiliy Karanadze, MD, PhD
Phone +79035656830
Email karanadzev@mail.ru
Status Recruiting
Phase
Start date November 1, 2023
Completion date October 1, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04095624 - Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion N/A
Recruiting NCT05367609 - Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB) N/A
Terminated NCT03426137 - Relieving Acute Pain (RAP) Study: A Pilot Study Phase 2
Active, not recruiting NCT04629807 - Anterior Gen Plus Study N/A
Active, not recruiting NCT04379921 - Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch N/A
Completed NCT02280187 - InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study N/A
Completed NCT06082245 - TLIP Block and ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery N/A
Recruiting NCT06102681 - Examination of the Effect of Early Mobilization on Postoperative Recovery, Pain, Quality of Life and Complication Development in Elective Minimally Invasive Spine Surgery N/A
Active, not recruiting NCT05001893 - Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
Completed NCT04711668 - Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery N/A
Not yet recruiting NCT05850468 - Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries. N/A
Completed NCT04682418 - Pedicle Screw Placement With XVS N/A
Not yet recruiting NCT06393530 - Erector Spinae Plane Block for Cervical Spine Surgery Phase 4
Not yet recruiting NCT04679844 - Post Marketing Study of MagnetOs Putty Compared to Demineralized Bone Matrix (DBM) Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion N/A
Not yet recruiting NCT04568837 - Steroids After Spine Fusion Surgery Phase 4
Completed NCT05401526 - Fluid Responsiveness in Prone Position
Not yet recruiting NCT05037968 - MagnetOs Flex Matrix Compared to Cell Based Allografts in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion N/A
Not yet recruiting NCT06450834 - Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE
Not yet recruiting NCT05691062 - Titanium vs. PEEK Fusion Devices in 1 Level TLIF Phase 4
Recruiting NCT04839783 - Single Position Spine Surgery Registry