The Efficacy of the Longeviti ClearFit Implant in Craniectomies for Post-Operative Monitoring in Chronic Subdural Hematomas

Study Overview
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Brief Summary
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Chronic subdural hematomas are frequent neurosurgical issues that are most often treated with burr hole craniectomies to drain the subdural fluid. At the chronic stage, a subdural hematoma is more liquified and easily washed out through burr hole openings. However, it often requires frequent imaging and monitoring to ensure that fluid does not reaccumulate in the subdural space, that the washout was adequate, and that further intervention/repeat intervention is not required, particularly if the patient develops acute changes in neurologic status or lacks improvement in initial symptomatology. Therefore, these patients require multiple repeated CT head images during their inpatient and post-operative follow-up course. This leads to high radiation doses to patients and high-cost burden. The Longeviti ClearFit Cover was developed to allow for ultrasound imaging through the implanted cover. The skull's acoustic properties prevent ultrasound from being used through the bone, therefore limiting its use in post-operative neurosurgical patients. Using ultrasound would remove the need for high radiation doses with CT, could be done very quickly and easily at bedside or in the clinic to check subdural space or ventricle size, and is much lower cost. This ClearFit implant would be utilized in place of a burr hole cover, typically titanium, that is implanted in most other cases. The aim of this study is to prospectively assess patients with surgically treated chronic subdural hematomas via craniectomy that have the craniectomy site covered with the Longeviti ClearFit, compared retrospectively to a matched cohort of patients that had their craniectomy site for the same procedure covered with the typically used titanium/metal. This will allow us to determine if this new implant results in reduced need for repeated CT imaging by utilizing bedside clinician-performed ultrasound and reduces overall cost for patients.

Official Title
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The Efficacy of the Longeviti ClearFit Implant in Craniectomies for Post-Operative Monitoring in Chronic Subdural Hematomas

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Device: ClearFit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients >18 years old; patients determined by surgeon to have a chronic subdural hematoma that is treated with craniectomy that would allow for implantation of a ClearFit cover Exclusion Criteria: Pediatric patients, patient with allergy to the material the implant is made with (polymethylmethacrylate)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ClearFit Longeviti Implant<br>Patients with chronic subdural hematomas that qualify for study and agree to participate will receive the ClearFit implant to cover the craniectomy site and have ultrasound imaging for their post-operative follow-up rather than CT/MRI, with exception of first initial post-op CT scan, and crossover to CT/MRI if clinically indicated or required for diagnostic purposes/patient safety | Device: ClearFit<br>* Implantation of ClearFit Longeviti Craniectomy Cover<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Radiation | Amount of radiation exposure to patient with ClearFit obtaining ultrasounds rather than CT compared to retrospective control group | from time of implant to last follow-up, anticipate 1 year | 
| Patient cost | Overall cost to patient with ClearFit compared to retrospective control group | from time of implant to last follow-up, anticipate 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of imaging | Calculated based on number of cross-overs from ultrasound to CT or MRI, with noted reason for crossover. Analysis of how often ultrasound is unable to be used/not feasible for post-operative monitoring of subdural, statistical analysis of crossover out of ultrasound into CT/MRI cranial imaging | from time of implant to last follow-up, anticipate 1 year | 
| Provider experience caring for patient | Survey of ease to care for patient in post-operative time period, ultrasound for imaging, transport of patient to obtain imaging, ease of access | from time of implant to last follow-up, anticipate 1 year |