Study

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor AO Foundation, AO Spine
Registry number NCT06839300
Started 9 February 2026 Today 16 October 2026 Estimated completion 1 December 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Prince of Wales Hospital Sydney NSW Not yet recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 19 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 260

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Age ≥ 19 years

* Blunt (non-penetrating) traumatic SCI

* Baseline neurologic impairment deemed "complete" (AIS grade A) or "incomplete" (AIS grade B, C, or D) based on clinical history/examination and/or diagnostic imaging

* Bony spinal level involvement between C0 and L1, inclusive

* Ability to have initial blood sample drawn within 24 hours of injury

* Treated either surgically or non-surgically

* Ability to provide informed consent according to the IRB/EC defined and approved procedures

Inclusion criteria for non-spinal cord injury spinal trauma control participants:

* Age ≥ 19 years

* Traumatic spinal fracture and/or dislocation between C0 and L1 (inclusive) without SCI

* Treated either surgically or nonsurgically

* Ability to have initial blood sample drawn within 24 hours of injury

* Ability to provide informed consent according to the IRB/EC defined and approved procedures

Exclusion Criteria:

* Penetrating SCI (eg, gunshot, stab)

* Previous SCI

* Isolated spinal injury below L1

* Isolated radiculopathy without fracture

* Isolated cauda equina injury

* Patients with known diagnosis of multiple sclerosis

* Preexisting thromboembolic disease or coagulopathy (disorders related to blood clotting), such as hemophilia or von Willebrand disease

* Patients who in the investigator's opinion will not be compliant with the study procedures and patients who have any other conditions/injuries that in the investigator's opinion would render the study procedures dangerous

Dates on the record

Started 9 February 2026
Estimated completion 1 December 2029
Registry last updated 1 October 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 1 October 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.