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Dynamic Decompressive Craniotomy

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ClinicalTrials.gov Identifier: NCT05051488
Recruitment Status : Not yet recruiting
First Posted : September 21, 2021
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Halifax Health
Information provided by (Responsible Party):
Rohit Khanna, MD, NeuroVention, LLC

Brief Summary:
Prospective observational study on patients undergoing decompressive craniotomy

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Decompressive Craniotomy
Estimated Study Start Date : April 30, 2022
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023



Intervention Details:
  • Procedure: Dynamic craniotomy
    Dynamic decompressive craniotomy with semi-rigid bone flap fixation
  • Device: Dynamic craniotomy
    Dynamic decompressive craniotomy with semi-rigid bone flap fixation


Primary Outcome Measures :
  1. Clinical outcome [ Time Frame: 6 months ]
    Modified Rankin Scale and Glasgow Outcome Score

  2. Craniotomy bone flap healing [ Time Frame: 3 months ]
    CT scan to assess rate of normal bone flap position



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from malignant strokes, traumatic brain injury, and/or brain tumors. Patients not expected to survive will be excluded.
Criteria

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.
Additional Information:
Publications:
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Responsible Party: Rohit Khanna, MD, Principal Investigator, NeuroVention, LLC
ClinicalTrials.gov Identifier: NCT05051488    
Other Study ID Numbers: 1
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rohit Khanna, MD, NeuroVention, LLC:
decompressive craniotomy
dynamic craniotomy
craniectomy
cranial fixation plate
cerebral swelling
intracranial hypertension
cranioplasty
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Stroke
Cerebral Hemorrhage
Brain Edema
Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages