Status:
COMPLETED
Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Stryker Orthopaedics
Conditions:
Hematoma, Subdural, Chronic
Hematoma, Subdural, Intracranial
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The clinical-functional result after frontal and parietal burr-hole trepanation for the treatment of chronic subdural hematoma (cSDH) is effective with regards to control of the hematoma and regressio...
Eligibility Criteria
Inclusion
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Patients with first-time cSDH (hypodense, isodense, hyperdense or mixed-type in CT-imaging), scheduled for uni- or bilateral double burr hole trepanation under general anesthesia
- Patient age ≥ 18 years
- Patient non-comatose at time of inclusion (GCS \> 8 points)
- Patient able to communicate (in terms of ability to hear, see, speak and understand)
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Patient with recurrent cSDH or previous surgery for cSDH
- Patient with cSDH treated by craniotomy or by single burr hole trepanation
- Patient with cSDH treated in local anesthesia
- Patient unlikely to attend the follow-up (due to reasons of residency, dismal prognosis, etc.)
- Pregnancy
- Known allergy against or incompatibility with Titanium
- Known or suspected non-compliance
- Inability to follow the study procedures, e.g. due to psychological disorders, dementia, etc. of the participant
Exclusion
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03755349
Start Date
January 29 2019
End Date
January 31 2022
Last Update
October 3 2022
Active Locations (1)
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1
University Hospital Zurich & University of Zurich
Zurich, Canton of Zurich, Switzerland, 8091