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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