Dynamic Decompressive Craniotomy

April 4, 2022 updated by: Rohit Khanna, MD
Prospective observational study on patients undergoing decompressive craniotomy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rohit Khanna, MD

Collaborators

Halifax Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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