Dynamic Decompressive Craniotomy

Stroke, Acute Clinical Trial

Official title:

Dynamic Decompressive Craniotomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05051488
• Other study ID #: 1
• Status: Not yet recruiting
• Start date: April 30, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: NeuroVention, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective observational study on patients undergoing decompressive craniotomy

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Edema
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Tumor
• Cerebral Hemorrhage
• Hemorrhage
• Stroke
• Stroke, Acute
• TBI (Traumatic Brain Injury)

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rohit Khanna, MD	Halifax Health

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome	Modified Rankin Scale and Glasgow Outcome Score	6 months
Primary	Craniotomy bone flap healing	CT scan to assess rate of normal bone flap position	3 months

External Links

•   Dynamic craniotomy video