Dynamic Decompressive Craniotomy

Rohit Khanna, MD20 enrolled

Overview

Prospective observational study on patients undergoing decompressive craniotomy

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Dynamic craniotomyPROCEDURE

Dynamic decompressive craniotomy with semi-rigid bone flap fixation

Dynamic craniotomyDEVICE

Dynamic decompressive craniotomy with semi-rigid bone flap fixation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical outcome

Modified Rankin Scale and Glasgow Outcome Score

Time frame: 6 months

Craniotomy bone flap healing

CT scan to assess rate of normal bone flap position

Time frame: 3 months

Data from ClinicalTrials.gov

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