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Spine fracture study: surgery vs. no surgery – which is better?

NCT ID NCT06059820

Knowledge-focused Sponsor: Sklifosovsky Institute of Emergency Care Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 40 adults with certain types of spine fractures in the chest or lower back that did not cause nerve problems. Researchers compared outcomes between patients who had surgery (spinal fusion) and those who received conservative care like bracing and exercises. The goal was to see which approach leads to better long-term function and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors choose the best treatment for spine fractures without nerve damage, potentially avoiding unnecessary surgery.
What could go wrong
This is a small, completed observational study with only 40 participants, so results may not apply to everyone. It does not test a new drug or treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

40 people

The number who actually took part.

Started

Nov 2023

Finished

Sep 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All participants in the study are patients with spinal fractures who arrived through the emergency medical services and were urgently admitted to the hospital.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bone fracture spinal fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fracture of spine, level unspecified Lumbar; spine, fracture Spine fracture Spine fusion Thoracic spine fracture Thoracolumbar burst fracture

Contacts and locations

Locations

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

    Moscow, 111674, Russia

  • Sklifosovsky Research Institute for Emergency Medicine

    Moscow, 107045, Russia

More trials for these conditions

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