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

NCT06059820 | Completed DMC

• 1 other identifier: 1-28-08/2023
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• The SF-36 v.1 (Standard Form)

  admission, 3, 6 and 12 months

• EQ-5D-5L

  admission, 3, 6 and 12 months

• ASA

  admission

• Rivermead Mobility Index

  1, 3, 6 and 12 months

• Lovett's muscle testing

  1, 3, 6 and 12 months

Study Arms (2)

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.

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.

Procedure: Spine fusion

Interventions

rehabilitation treatment OTHER

3-month immobilization period, hyperextension braces for specific fractures, therapeutic exercises, and gradual activity restoration.

Conservative treatment group

Spine fusion PROCEDURE

Pedicle screw fixation or fusion; anterior plate fusion

Surgical treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sklifosovsky Institute of Emergency Care: lead

Study Sites (2)

Sklifosovsky Research Institute for Emergency Medicine

Moscow, 107045, Russia

Location

Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine

Moscow, 111674, Russia

Location

MeSH Terms

Conditions

Fractures, Bone; Spinal Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Wounds and Injuries; Spinal Injuries; Back Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: neurosurgeon

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: September 29, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

RU (2)