Brain Edema, Brain Tumor, Cerebral Hemorrhage, Stroke, Acute, TBI (Traumatic Brain Injury)
Conditions
Keywords
decompressive craniotomy, dynamic craniotomy, craniectomy, cranial fixation plate, cerebral swelling, intracranial hypertension, cranioplasty
Brief summary
Prospective observational study on patients undergoing decompressive craniotomy
Detailed description
A prospective study of 20 neurosurgical patients evaluating the dynamic decompressive craniotomy technique using NeuroVention, LLC craniotomy bone flap fixation plates. The plates allow for rigid and semi-rigid bone flap fixation dependent on the implantation technique. A dynamic craniotomy involves bone flap fixation wherein a limited transient outward bone flap movement is allowed by the plates to compensate for an increase in intracranial pressure from brain swelling. The plates also prevent the craniotomy bone flap from sinking inside the skull and compressing on the brain. Cerebral decompression surgery is undertaken for patients with cerebral swelling from malignant strokes, medically intractable intracranial pressure elevation in traumatic brain injuries and brain tumors. The dynamic craniotomy technique eliminates or reduces the need for a cranioplasty surgery with a potentially significant improvement in outcome.
Interventions
PROCEDUREDynamic craniotomy
Dynamic decompressive craniotomy with semi-rigid bone flap fixation
Sponsors
Halifax Health
Rohit Khanna, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from a malignant stroke * Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from traumatic brain injury * Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from brain tumors.
Exclusion criteria
* Patients with blown pupil (cerebral herniation), * Massive brain swelling * Dismal outcome not expected to survive more than 1-2 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | 6 months | Modified Rankin Scale and Glasgow Outcome Score |
| Craniotomy bone flap healing | 3 months | CT scan to assess rate of normal bone flap position |
Outcome results
None listed