Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

QUESTION. Does duroplasty improve outcome after spinal cord injury? WHAT DO WE STUDY? We will investigate whether performing a surgical procedure called duroplasty improves outcomes after spinal cord injury. WHY SPINAL CORD INJURY? Spinal cord injury is a devastating condition that causes permanent disability such as paralysis, numbness and loss of bladder and bowel control. Currently, there are no treatments shown to improve outcome after spinal cord injury. WHAT IS DUROPLASTY? Duroplasty is an operation that involves opening the tough membrane around the cord, called the dura, and stitching a patch of artificial dura to expand the space around the swollen cord. WHY IS DUROPLASTY BEING STUDIED? Based on our preliminary evidence, we think that the dura causes cord pressure after injury. We have shown in a small study of patients that performing this operation safely and effectively reduces pressure on the injured cord. WHO IS ELIGIBLE? Adult patients with severe spinal cord injuries in the neck who will have surgery within 72 hours. WHAT TREATMENT? Those who agree to take part will be allocated by chance (like tossing a coin) to standard treatment or standard treatment plus duroplasty. Some patients will also be asked to take part in a smaller study that involves placing probes at the injury site. WHERE? We will recruit patients from U.K. Major Trauma Centres. Most assessments will be done in U.K. Spinal Injury Centres. Later on, we may recruit from overseas. HOW LONG? We aim to recruit 222 - 260 patients over 4 years. Patients will be followed up for a year. WHAT DO WE ASSESS? Patients will be assessed (using questionnaires and by examination) how well they can use their hands, walk, control their bladder and bowel and their quality of life. Some of these assessments will be repeated at 3, 6 and 12 months after surgery. WHAT IS THE OPTIONAL MECHANISTIC STUDY? DISCUS includes an optional study for at least 50 patients who will take part in the randomised controlled trial. The aim of the mechanistic study is to determine how duroplasty improves outcome, i.e. whether duroplasty reduces cord compression, improves blood flow to the injured cord perfusion, improves cord metabolism and reduces cord inflammation. WHAT IS THE OPTIONAL INFORMATION STUDY? For the first two years, a study called QuinteT Recruitment Intervention (QRI) is designed to optimise patient recruitment and informed consent in the trauma setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• Age ≥16 years

• Severe cervical (C2 - T1) traumatic spinal cord injury (AIS grade A-C)

• Deemed to require and be suitable for surgery that includes laminectomy by local surgeon

• Surgery within 72 hours of traumatic spinal cord injury

• Able to provide informed consent or consultee declaration or proxy consent.

Locations
Other Locations
Austria
Universität Klinik für Neurochirurgie
RECRUITING
Innsbruck
Kepler University Hospital
RECRUITING
Linz
University Hospital Salzburg
RECRUITING
Salzburg
Belgium
UZ Leuven
RECRUITING
Leuven
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Germany
BG Unfallklinik Frankfurt am Main
RECRUITING
Frankfurt
Israel
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Centre
RECRUITING
Jerusalem
Slovenia
University Medical Centre Ljubljana
RECRUITING
Ljubljana
Spain
12 de Octubre University Hospital
RECRUITING
Madrid
Sweden
Skåne University Hospital
RECRUITING
Lund
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
National Spinal Injuries Centre
ACTIVE_NOT_RECRUITING
Aylesbury
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Queen Elizabeth University Hospital
RECRUITING
Glasgow
Hull Royal Infirmary
RECRUITING
Hull
Leeds General Infirmary
RECRUITING
Leeds
The Walton Centre
RECRUITING
Liverpool
King's College Hospital
RECRUITING
London
St George's Hospital
RECRUITING
London
St Mary's Hospital
RECRUITING
London
The London Spinal Cord Injury Centre
ACTIVE_NOT_RECRUITING
London
The Royal London Hospital
RECRUITING
London
Queen's Medical Centre
RECRUITING
Nottingham
Midlands Centre for Spinal Injuries,
ACTIVE_NOT_RECRUITING
Oswestry
Salford Royal
RECRUITING
Salford
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
North West Regional Spinal Injuries Centre
ACTIVE_NOT_RECRUITING
Southport
Pinderfields Hospital
ACTIVE_NOT_RECRUITING
Wakefield
Contact Information
Primary
Melody Chin
discus@nds.ox.ac.uk
079 17100953
Backup
Ghazal Ebrat
gebrat@sgul.ac.uk
Time Frame
Start Date: 2021-10-08
Estimated Completion Date: 2026-10-08
Participants
Target number of participants: 222
Treatments
Active_comparator: Duroplasty
Duroplasty (includes Surgery with Laminectomy)
Active_comparator: No duroplasty
No duroplasty (but includes surgery with Laminectomy)
Related Therapeutic Areas
Sponsors
Collaborators: St George's University Hospitals NHS Foundation Trust, University of Cambridge, St. Mary's University, Twickenham, Buckinghamshire Healthcare NHS Trust, University of Bristol, Ohio State University, University of Oxford
Leads: St George's, University of London

This content was sourced from clinicaltrials.gov