Expansile Duraplasty for Spinal Cord Injury
(DATSCI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a surgical technique called expansile duraplasty can improve recovery after a sudden spinal cord injury. The trial compares recovery outcomes between two groups: one group receives this procedure during their standard spinal surgery, while the other does not. It aims to determine if expansile duraplasty enhances strength, movement, and overall recovery. Individuals with a recent traumatic spinal cord injury, currently hospitalized and undergoing surgery, may be eligible to join. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance recovery methods for spinal cord injuries.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that expansile duraplasty is safe for spinal cord injury?
Research has shown that expansile duraplasty is generally well-tolerated by people with sudden spinal cord injuries. A retrospective study found it safe and feasible for these patients, indicating no serious side effects occurred. Although research is limited, existing information suggests the treatment usually does not cause problems.
In summary, current studies suggest expansile duraplasty appears safe, but further research could provide additional clarity.12345Why are researchers excited about this trial?
Researchers are excited about expansile duraplasty for spinal cord injury because it introduces a new surgical method that could enhance recovery. Unlike current treatment options, which primarily focus on stabilizing the spine and reducing inflammation, expansile duraplasty involves expanding the dura mater—the protective covering of the spinal cord—during surgery. This method aims to reduce pressure on the spinal cord, potentially improving nerve function and overall recovery outcomes. By directly addressing the physical constraints on the spinal cord, expansile duraplasty could offer a novel way to support healing and improve long-term function for patients with spinal cord injuries.
What evidence suggests that expansile duraplasty is effective for spinal cord injury?
This trial will compare expansile duraplasty with standard surgery for spinal cord injury. Research has shown that expansile duraplasty, a surgical technique for spinal cord injuries, can enhance recovery. In one study, patients who underwent this surgery regained more strength and movement than those who did not. Another review suggested that this technique might improve recovery, but further research is needed for confirmation. Overall, expansile duraplasty appears promising for aiding recovery in people with spinal cord injuries.23678
Who Is on the Research Team?
Rajiv Saigal, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults who've recently suffered an acute traumatic spinal cord injury. To participate, they must be undergoing standard SCI surgery and willing to provide blood and cerebrospinal fluid samples, undergo MRI scans, have their movement assessed, and complete health questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Blood and cerebrospinal fluid samples are collected, and MRI scans are performed pre-operatively
Treatment
Participants undergo standard SCI surgery with or without expansile duraplasty, followed by intensive care monitoring
Acute Care and Monitoring
Participants receive standard of care treatment, including hemodynamic and pressure monitoring, and are monitored for adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months post-injury
What Are the Treatments Tested in This Trial?
Interventions
- Expansile duraplasty
Trial Overview
The study tests if expansile duraplasty improves recovery in acute traumatic SCI patients. Participants are randomly assigned to either receive the procedure during standard surgery (Experimental group) or not (Control group), then monitored for strength, movement, and overall recovery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this arm receive expansile duraplasty during their standard surgery for spinal cord injury.
Participants in this arm do not receive expansile duraplasty during their standard surgery for spinal cord injury.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
United States Department of Defense
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Department of Defense Congressionally Directed Medical Research Program
Collaborator
Citations
Retrospective Analysis of Expansile Duraplasty as Surgical ...
Our study found that patients who underwent expansile duraplasty had a significantly greater increase in motor score from baseline to inpatient ...
Duraplasty for Acute Traumatic Spinal Cord Injury
The goal of this clinical trial is to learn if a procedure called "expansile duraplasty" can improve recovery in adults who have experienced ...
The outcome of injured cervical spinal cord with ...
The ISCUD trial aims (1) to evaluate the benefits and risks of combining expansive duroplasty with standard treatment compared to standard ...
4.
pure.johnshopkins.edu
pure.johnshopkins.edu/en/publications/duraplasty-in-acute-spinal-cord-injury-a-systematic-review/Duraplasty in acute spinal cord injury: a systematic review
Conclusion: Expansile duraplasty shows promise in patients with aSCI and may be effective in enhancing patient outcomes. Current literature remains scarce and ...
Surgical Timing After Spinal Cord Injury
Their results showed that 19.8% of patients undergoing early surgery experienced a ≥2-grade improvement in the ASIA Impairment Scale (AIS) ...
Duraplasty in acute spinal cord injury: a systematic review
Conclusion: Expansile duraplasty shows promise in patients with aSCI and may be effective in enhancing patient outcomes. Current literature remains scarce and ...
The outcome of injured cervical spinal cord with uncontrolled ...
The primary outcome is the change in motor score at 6 months compared to admission; while the secondary outcome assess the sensory score, the ...
Surgical Timing After Spinal Cord Injury
Expansile duraplasty improves motor outcomes after acute traumatic spinal cord injury. Spine J 22:S102-S103, 2022 CROSSREF. 33. Sattari SA ...
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