Skull defect
Conditions
Interventions
trial group:Polyetheretherketone (PEEK) material
control group:titanium mesh material
Sponsors
The Fourth Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with traumatic brain injury who received decompressive craniectomy or intracerebral hemorrhage craniotomy to remove hematoma; 2. Patients who underwent cranioplasty for the first time 12 weeks after decompressive craniectomy; 3. Adult patients (aged >= 18 years old), regardless of gender; 4. Patients with unilateral skull defect; 5. Patients who signed informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient's condition before cranioplasty was poor, such as sepsis and brain swelling; 2. Patients with uncontrolled intracranial infection or intracranial hematoma before cranioplasty; 3. Patients who had been operated on skull defect for many times in the past; 4. The patient is allergic to transplantation materials; 5. Patients with history of brain tumor; 6. Patients with history of epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of failure in skull repair at 24 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of failure in skull repair at 6 and 12 months after surgery;The incidence of adverse events at 6, 12, and 24 months after surgery;Glasgow Outcome Scale (GOS) scores at 6, 12, and 24 months after surgery;Satisfaction score for body shaping at 6, 12, and 24 months after surgery;Head CT imaging at 6, 12, and 24 months after surgery; | — |
Countries
China
Contacts
Public ContactFeng Zhang
The Fourth Affiliated Hospital of China Medical University
Outcome results
None listed