Recruiting

Observational Study

Sponsor:

AO Foundation, AO Spine

Code:

NCT06839300

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.

Conditions

Spinal Cord Injury

Study ID

NCT06839300

Start date

Feb 9, 2026

Status verified date

May, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

260 participants

Anticipated

Interventions and Outcome Measures

Arms

SCI patients

Patients with traumatic SCI

Non-SCI patients (control group)

Non-SCI spine trauma control participants

Primary outcome measure

  • Accuracy of serum NF-L and GFAP biomarkers postinjury for predicting the severity of neurologic imapairement at 6 months postinjury as either motor complete or motor incomplete. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Alix Frischknecht

+41 79 606 41 48alix.frischknecht@aofoundation.org

Marije de Jong

+41 79 529 68 60marije.dejong@aofoundation.org

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Aditya Vedantam

avedantam@mcw.edu

More Information

Sponsor

AO Foundation, AO Spine

Last update posted

May 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AO Foundation, AO Spine on 2026-05-05.