Dynamic Decompressive Craniotomy

Sponsor

Rohit Khanna, MD (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05051488

Collaborator

Halifax Health (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Prospective observational study on patients undergoing decompressive craniotomy

Condition or Disease	Intervention/Treatment	Phase
Brain Edema TBI (Traumatic Brain Injury) Stroke, Acute Cerebral Hemorrhage Brain Tumor	Procedure: Dynamic craniotomy Device: Dynamic 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dynamic Decompressive Craniotomy

Anticipated Study Start Date :

Apr 30, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.