Dynamic Decompressive Craniotomy

NCT05051488 | Unknown FDA Device

• 1 other identifier: 1
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective observational study on patients undergoing decompressive craniotomy

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

Outcome Measures

Primary Outcomes (2)

• Clinical outcome

  Modified Rankin Scale and Glasgow Outcome Score

  6 months

• Craniotomy bone flap healing

  CT scan to assess rate of normal bone flap position

  3 months

Interventions

Dynamic craniotomy PROCEDURE

Dynamic decompressive craniotomy with semi-rigid bone flap fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with blown pupil (cerebral herniation),
• Massive brain swelling
• Dismal outcome not expected to survive more than 1-2 weeks.

Sponsors & Collaborators

• Rohit Khanna, MD: lead
• Halifax Health: collaborator

Related 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. Print 2020 Feb 1.

  PMID: 30611148 BACKGROUND

• 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.

  PMID: 26654180 BACKGROUND

• 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.

  PMID: 27903020 BACKGROUND

Related Links

• Dynamic craniotomy video

MeSH Terms

Conditions

Brain Edema; Brain Injuries, Traumatic; Stroke; Cerebral Hemorrhage; Brain Neoplasms; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 21, 2021
• Study Start: April 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share