Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04936620
Status:
RECRUITING
Last Update Posted:
2022-10-27
First Post:
2021-06-21
Brief Title:
Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCUS
Brief 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 UK Major Trauma Centres Most assessments will be done in UK 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 ie 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
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 UK Major Trauma Centres Most assessments will be done in UK 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 ie 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
Detailed Description:
RESEARCH QUESTION After severe traumatic spinal cord injury TSCI does the addition of dural decompression to bony decompression includes laminectomy improve muscle strength in the limbs at 6 months compared with bony decompression alone BACKGROUND TSCI is a devastating condition that affects about 1000 people in the UK annually Most remain disabled tetraplegic or wheelchair bound and are dependent on carers with significant cost to patients carers and the NHS Surgery aims to reduce spinal deformity stabilise the spine and achieve bony decompression of the cord To date no treatments have been shown to improve outcome
AIMS OBJECTIVES The primary aim is to determine if in patients with acute severe TSCI the addition of dural decompression to bony decompression improves muscle strength We hypothesise that after TSCI the cord swells and is compressed against the dura Secondary objectives are to assess patient impact ie functional outcomes health related quality of life HRQoL complication rates and mortality Mechanistic sub-studies aim to determine if the addition of duroplasty improves cord perfusion reduces cord ischaemia and cord inflammation
METHODS This is a prospective phase III multicentre randomised controlled trial RCT We aim to recruit 222 adults with acute severe cervical TSCI American spinal injuries association Impairment Scale AIS grade A B or C who will be randomised 11 to undergo bony decompression alone versus bony decompression with duroplasty Patients and assessors will be blinded to study arm The primary outcome is change in AIS motor score AMS at 6 months compared with admission Delta-AMS secondary outcomes will assess function grasp walking urinary anal sphincters HRQoL complications need for further surgery and mortality assessed at baseline 3 months 6 months and 12 months from randomisation A subgroup of 50 patients 25 per arm will also have observational monitoring from the injury site using a pressure probe intraspinal pressure ISP spinal cord perfusion pressure SCPP and microdialysis MD catheter cord metabolism tissue glucose lactate pyruvate lactate-to-pyruvate ratio LPR glutamate glycerol cord inflammation tissue chemokinescytokines Patients will be recruited from the 26 UK major trauma centres MTCs
TIMELINES FOR DELIVERY The study duration is 72 months and includes 6 months set-up 48 months recruitment 12 months to complete follow-up and 6 months for data analysis and final reporting of results There will be a formal stopgo review at month 15 after 9 months of recruitment to ensure a minimum of 4 sites have been opened and 8 patients randomised If these targets are met the trial will recruit for a further 36 months Data from the pilot will be included in the final analysis
ANTICIPATED IMPACT AND DISSEMINATION It is anticipated that the addition of duroplasty to standard of care will improve muscle strength in patients this has obvious benefits for patients and their carers as well as substantial gains for the NHS and society including economic implications If this RCT shows that the addition of duroplasty to standard treatment is beneficial it is anticipated that duroplasty will become standard NHS care in all 26 UK MTCs Participants will be informed of study findings via the Surgical Intervention Trials Unit SITU website and the Spinal Injuries Association SIA
AIMS OBJECTIVES The primary aim is to determine if in patients with acute severe TSCI the addition of dural decompression to bony decompression improves muscle strength We hypothesise that after TSCI the cord swells and is compressed against the dura Secondary objectives are to assess patient impact ie functional outcomes health related quality of life HRQoL complication rates and mortality Mechanistic sub-studies aim to determine if the addition of duroplasty improves cord perfusion reduces cord ischaemia and cord inflammation
METHODS This is a prospective phase III multicentre randomised controlled trial RCT We aim to recruit 222 adults with acute severe cervical TSCI American spinal injuries association Impairment Scale AIS grade A B or C who will be randomised 11 to undergo bony decompression alone versus bony decompression with duroplasty Patients and assessors will be blinded to study arm The primary outcome is change in AIS motor score AMS at 6 months compared with admission Delta-AMS secondary outcomes will assess function grasp walking urinary anal sphincters HRQoL complications need for further surgery and mortality assessed at baseline 3 months 6 months and 12 months from randomisation A subgroup of 50 patients 25 per arm will also have observational monitoring from the injury site using a pressure probe intraspinal pressure ISP spinal cord perfusion pressure SCPP and microdialysis MD catheter cord metabolism tissue glucose lactate pyruvate lactate-to-pyruvate ratio LPR glutamate glycerol cord inflammation tissue chemokinescytokines Patients will be recruited from the 26 UK major trauma centres MTCs
TIMELINES FOR DELIVERY The study duration is 72 months and includes 6 months set-up 48 months recruitment 12 months to complete follow-up and 6 months for data analysis and final reporting of results There will be a formal stopgo review at month 15 after 9 months of recruitment to ensure a minimum of 4 sites have been opened and 8 patients randomised If these targets are met the trial will recruit for a further 36 months Data from the pilot will be included in the final analysis
ANTICIPATED IMPACT AND DISSEMINATION It is anticipated that the addition of duroplasty to standard of care will improve muscle strength in patients this has obvious benefits for patients and their carers as well as substantial gains for the NHS and society including economic implications If this RCT shows that the addition of duroplasty to standard treatment is beneficial it is anticipated that duroplasty will become standard NHS care in all 26 UK MTCs Participants will be informed of study findings via the Surgical Intervention Trials Unit SITU website and the Spinal Injuries Association SIA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 25573423 | REGISTRY | ISRCTN | None |