Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

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.

Conditions

• Spinal Cord Injuries

Interventions

PROCEDURE

Duroplasty

Expansion Duroplasty

PROCEDURE

Spinal surgery

Spinal surgery including laminectomy

Sponsors & Collaborators

• St George's University Hospitals NHS Foundation Trust

  collaborator OTHER

• St. Mary's University, Twickenham

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Buckinghamshire Healthcare NHS Trust

  collaborator OTHER

• Paracelsus Medical University

  collaborator OTHER

• St George's, University of London

  lead OTHER

Principal Investigators

• Marios C Papadopoulos · St George's, University of London, U.K.

• Samira Saadoun · St George's, University of London, U.K.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-08

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• Austria
• Belgium
• China
• Czechia
• Denmark
• Finland
• Germany
• Israel
• Slovenia
• Spain
• Sweden
• United Kingdom

Study Locations