Clinical trial NCT05051488: Dynamic Decompressive Craniotomy
Official title: Dynamic Decompressive Craniotomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Edema
TBI (Traumatic Brain Injury)
Stroke, Acute
Cerebral Hemorrhage
Brain Tumor
Keywords: decompressive craniotomy
dynamic craniotomy
craniectomy
cranial fixation plate
cerebral swelling
intracranial hypertension
cranioplasty
Lead sponsor: NeuroVention, LLC
Sponsor class: INDUSTRY
Collaborators: name: Halifax Health
First posted: 2021-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Clinical outcome
timeFrame: 6 months
measure: Craniotomy bone flap healing
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Khanna R, Ferrara L, Khanna S. Biomechanics of a novel reversibly expandable dynamic craniotomy bone flap fixation plate. J Neurosurg. 2019 Jan 4;132(2):560-567. doi: 10.3171/2018.8.JNS172614. Print 2020 Feb 1.
citation: Khanna R, Ferrara L. Dynamic telescopic craniotomy: a cadaveric study of a novel device and technique. J Neurosurg. 2016 Sep;125(3):674-82. doi: 10.3171/2015.6.JNS15706. Epub 2015 Dec 11.
citation: Khanna R. Dynamic Decompressive Craniotomy with a Novel Reversibly Expandable Plate. J Neurol Surg A Cent Eur Neurosurg. 2017 Jul;78(4):386-389. doi: 10.1055/s-0036-1594013. Epub 2016 Nov 30.