Fractured Spine Clinical Trials

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The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
Wisconsin
Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Other Locations
Australia
Prince of Wales Hospital
NOT_YET_RECRUITING
Sydney
Brazil
Cajuru University Hospital
NOT_YET_RECRUITING
Curitiba
Chile
Clinica Alemana de Santiago
RECRUITING
Santiago
Germany
Charité Berlin
NOT_YET_RECRUITING
Berlin
India
Sri Balaji Action Medical Institute
NOT_YET_RECRUITING
New Delhi
New Zealand
MIddlemore Hospital
NOT_YET_RECRUITING
Auckland
United Kingdom
King's College Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Alix Frischknecht
alix.frischknecht@aofoundation.org
+41 79 606 41 48
Backup
Marije de Jong
marije.dejong@aofoundation.org
+41 79 529 68 60
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 260
Treatments
SCI patients
Patients with traumatic SCI
Non-SCI patients (control group)
Non-SCI spine trauma control participants
Related Therapeutic Areas
Sponsors
Leads: AO Foundation, AO Spine

This content was sourced from clinicaltrials.gov