At a glance
ClinicalIndex Comparison Record- ✓Age 18-80 years
- ✓Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission
- ✓Non-penetrating SCI at neurologic level C2-C8 or T1-T12
- ✓Ability to undergo surgical intervention through posterior approach within 48 hours of injury
- ✕Unconsciousness or mental impairment preventing neurological assessment within 48 hours
- ✕ASIA Impairment Scale grade C, D, or E
- ✕Anterior-only approach sufficient for decompression and stabilization
- ✕Currently involved in another non-observational SCI research study or receiving investigational drug
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty
In Brief
A clinical study evaluating DMED and ANGI for Spinal Cord Injuries and Acute Traumatic Spinal Cord Injury. Currently recruiting, targeting 10 participants across 1 site.
Detailed Summary
This is a single-blinded (with outcome assessors blinded to treatment allocation), 12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of dorsal myelotomy and expansive duraplasty performed either without or with autologous nerve graft implantation after acute traumatic spinal cord injury. Ten participants will be allocated to receive either DMED (n=5) or DMED + ANGI (n=5) based on a block design. Participants and assessors will be blinded to group allocation. Excess sural nerve samples will be collected for banking/analysis (may include proteomic, culturing, genomic, cellular analysis).
Study Details
Timeline
Interventions
Decompression of spinal cord with stabilization - posterior approach.
Implantation of nerve tissue following decompression ans stabilization.