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Surgical procedure to improve outcomes after spinal cord injury

Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

NA · St George's, University of London · NCT04936620

This study is testing if a new surgery that adds a patch to relieve pressure on the spinal cord can help adults with severe spinal cord injuries get stronger and improve their quality of life compared to standard surgery alone.

Quick facts

PhaseNA
Study typeInterventional
Enrollment222 (estimated)
Ages16 Years and up
SexAll
SponsorSt George's, University of London (other)
Locations33 sites (Innsbruck and 32 other locations)
Trial IDNCT04936620 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether duroplasty, a surgical procedure that involves opening the dura and applying a patch to relieve pressure on the spinal cord, can improve outcomes for patients with severe spinal cord injuries. The study will compare the effects of duroplasty combined with bony decompression against bony decompression alone in adult patients with acute, severe cervical spinal cord injuries. The primary focus is to assess improvements in muscle strength at six months post-surgery, along with secondary outcomes related to functional health and quality of life. The trial aims to recruit 222 participants and is designed as a multicenter randomized controlled trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 16 and older with severe cervical spinal cord injuries requiring surgical intervention within 72 hours of injury.

Not a fit: Patients with life-limiting co-morbidities or those with thoracic or lumbar spinal cord injuries may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could significantly improve muscle strength and overall recovery for patients with severe spinal cord injuries.

How similar studies have performed: Preliminary evidence suggests that similar approaches may have been effective, but this specific method of duroplasty is being tested for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥16 years
2. Severe cervical (C2 - T1) traumatic spinal cord injury (AIS grade A-C)
3. Deemed to require and be suitable for surgery that includes laminectomy by local surgeon
4. Surgery within 72 hours of traumatic spinal cord injury
5. Able to provide informed consent or consultee declaration or proxy consent.

Exclusion Criteria:

1. Dural tear due to traumatic spinal cord injury
2. Life-limiting or rehabilitation-restricting co-morbidities
3. Thoracic or lumbar traumatic spinal cord injury
4. Other central nervous system disease

Where this trial is running

Innsbruck and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Spinal Cord Injuries, Decompression, surgical, Neurosurgery, Paralysis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.