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Spine fracture showdown: surgery or not?

NCT ID NCT05003180

Disease control Sponsor: Uppsala University 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at people with a single broken bone in the middle-to-lower back (thoracolumbar burst fracture) but no nerve damage. It compares two standard treatments: surgery and non-surgical care (like a brace). The goal is to see which approach leads to better daily function and less disability one year after the injury. About 202 adults aged 18-66 are taking part.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

202 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 66 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: * A single level thoracolumbar (Th10-L3) burst fracture, A3 or A4, according to the AO Spine classification * Aged 18-66 years * Informed consent * Acute injury with diagnosis and treatment within 2 weeks * May have minor fractures in adjacent vertebras if these fractures in themselves would not have resulted in any treatment * May have a single nerve root injury Exclusion Criteria: * Unable to consent, no consent given or not informed * Neurological injury involving more than a single level root, i.e., spinal cord and/or cauda equina injury * Definite rupture of the posterior tension band (through bony and/or ligamentous structures) verified on MRI * Patients with ankylosing spinal disorders spanning the fracture area * Prior spinal surgeries within the fractured area * Open vertebral fracture * Additional injury which would impair early ambulation, e.g., long bone fractures, severe head injury, long-lasting intensive care * Patients not deemed suitable due to severe co-morbidities. (E.g., established osteoporosis that would impair the possibility to maintain integrity of spinal implants, pathological fractures, severe cardiac or pulmonary compromise, or other systemic disease that would result in such high anesthesiologic risk that surgery would not be attempted.) * Patients already included in the study cannot be randomized again if they get an additional spine fracture

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Conditions

The condition(s) this trial relates to.

spinal fracture

As listed by the trial registrant

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

Thoracolumbar burst fracture

Contacts and locations

Locations

  • Akershus University Hospital

    Oslo, Norway

  • Central Hospital of Västerås

    Västerås, Sweden

  • Halmstad Hospital

    Halmstad, Sweden

  • Haukeland University Hospital

    Bergen, Norway

  • Kalmar Hospital

    Kalmar, Sweden

  • Karolinska University Hospital

    Stockholm, 14186, Sweden

  • Linköping University Hospital

    Linköping, Linköping, Sweden

  • Oslo University Hospital

    Oslo, Oslo, Norway

  • Ryhov Hospital

    Jönköping, Sweden

  • Sahlgrenska University Hospital

    Gothenburg, Gothenburg, Sweden

  • Skåne University Hospital

    Malmö, Malmö, Sweden

  • St. Olavs Hospital

    Trondheim, Norway

  • Stavanger University Hospital

    Stavanger, Norway

  • Stockholm South General Hospital

    Stockholm, Stockholm County, Sweden

  • University Hospital of Umeå

    Umeå, Umeå, Sweden

  • Uppsala University Hospital

    Uppsala, Uppsala County, Sweden

  • Örebro University Hospital

    Örebro, Sweden

More trials for these conditions

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