Dynamic Decompressive Craniotomy

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

• Registration Number: NCT05051488
• Lead Sponsor: Rohit Khanna, MD

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.

Study Timeline

• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06
• Study Start: 2022-04-30
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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