Dynamic Decompressive Craniotomy

Study Overview
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Brief Summary
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Prospective observational study on patients undergoing decompressive craniotomy

Detailed Description
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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.

Official Title
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Dynamic Decompressive Craniotomy

Conditions
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Stroke, Acute, Brain Edema, TBI (Traumatic Brain Injury), Cerebral Hemorrhage, Brain Tumor

Intervention / Treatment
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* Procedure: Dynamic craniotomy
* Device: Dynamic craniotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Dynamic craniotomy|Dynamic decompressive craniotomy with semi-rigid bone flap fixation|
|Device: Dynamic craniotomy|Dynamic decompressive craniotomy with semi-rigid bone flap fixation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Modified Rankin Scale and Glasgow Outcome Score | 6 months | 
| Craniotomy bone flap healing | CT scan to assess rate of normal bone flap position | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial hypertension, cranioplasty, decompressive craniotomy, dynamic craniotomy, craniectomy, cranial fixation plate, cerebral swelling