Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty
Francis Farhadi
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).
Description
Spinal cord injury (SCI) is associated with devastating personal burdens including paralysis, sensory changes, autonomic dysfunction, and chronic debilitating pain. Few effective treatments have been developed with standard of care consisting of state-of-the-art neurocritical care, timely surgical decompression, and rehabilitation. While a variety of novel neuroprotective and neuroregenerative approaches have been posited, clinical trials to date have failed to demonstrate associated clinical benefits. Current therapies are primarily aimed at reducing secondary injury processes, which are rel…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age: = 18 years and = 80 years * Written informed consent by patient or legal authorized representative * No other life-threatening injury * No evidence of sepsis * Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission * Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12 * The ability to undergo surgical intervention including study procedures through a posterior approach within 48 hours of injury Exclusion Criteria: * Unconsciousness or other mental impairment that prevents neurological assessment within the first 48 hours…
Interventions
- ProcedureDMED
Decompression of spinal cord with stabilization - posterior approach.
- ProcedureANGI
Implantation of nerve tissue following decompression ans stabilization.
Location
- University of Kentucky - Chandler Medical CenterLexington, Kentucky