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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClearFit Longeviti Implant | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearFit | Device | Implantation of ClearFit Longeviti Craniectomy Cover |
|
| 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 |
| 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 |
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Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31299743 | Background | Belzberg M, Shalom NB, Yuhanna E, Manbachi A, Tekes A, Huang J, Brem H, Gordon CR. Sonolucent Cranial Implants: Cadaveric Study and Clinical Findings Supporting Diagnostic and Therapeutic Transcranioplasty Ultrasound. J Craniofac Surg. 2019 Jul;30(5):1456-1461. doi: 10.1097/SCS.0000000000005454. | |
| 31188246 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| 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 |
| Belzberg M, Shalom NB, Lu A, Yuhanna E, Manbachi A, Tekes A, Huang J, Brem H, Gordon C. Transcranioplasty Ultrasound Through a Sonolucent Cranial Implant Made of Polymethyl Methacrylate: Phantom Study Comparing Ultrasound, Computed Tomography, and Magnetic Resonance Imaging. J Craniofac Surg. 2019 Oct;30(7):e626-e629. doi: 10.1097/SCS.0000000000005651. |
| 32149973 | Background | Hadley C, North R, Srinivasan V, Kan P, Burkhardt JK. Elective Sonolucent Cranioplasty for Real-Time Ultrasound Monitoring of Flow and Patency of an Extra- to Intracranial Bypass. J Craniofac Surg. 2020 May/Jun;31(3):622-624. doi: 10.1097/SCS.0000000000006225. |
| 32827747 | Background | Flores AR, Srinivasan VM, Seeley J, Huggins C, Kan P, Burkhardt JK. Safety, Feasibility, and Patient-Rated Outcome of Sonolucent Cranioplasty in Extracranial-Intracranial Bypass Surgery to Allow for Transcranioplasty Ultrasound Assessment. World Neurosurg. 2020 Dec;144:e277-e284. doi: 10.1016/j.wneu.2020.08.114. Epub 2020 Aug 20. |
| 36637272 | Background | Lee RP, Meggyesy M, Ahn J, Ritter C, Suk I, Machnitz AJ, Huang J, Gordon C, Brem H, Luciano M. First Experience With Postoperative Transcranial Ultrasound Through Sonolucent Burr Hole Covers in Adult Hydrocephalus Patients. Neurosurgery. 2023 Feb 1;92(2):382-390. doi: 10.1227/neu.0000000000002221. Epub 2022 Nov 15. |
| 35926403 | Background | Doron O, D'Amico RS, Langer DJ. The Cranial Window: Opportunities for the Use of Bedside Ultrasound Facilitated by Sonolucent Implants in Neurosurgical Patients. World Neurosurg. 2022 Sep;165:142-144. doi: 10.1016/j.wneu.2022.05.084. Epub 2022 May 23. No abstract available. |
| 29892260 | Background | Niesen WD, Rosenkranz M, Weiller C. Bedsided Transcranial Sonographic Monitoring for Expansion and Progression of Subdural Hematoma Compared to Computed Tomography. Front Neurol. 2018 May 28;9:374. doi: 10.3389/fneur.2018.00374. eCollection 2018. |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |