The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty. The secondary objective is to compare the complication rates and neurological function recover following cranioplasty. Complication events after cranioplasty are investigated within 6 months after surgery and neurological function is evaluated at 3, 6 and 12 months after cranioplasty.
Skull defect with a diameter greater than 3cm
No intracranial hemorrhage, intracranial hypertension or hydrocephalus (or treated) occurred more than 1 month after the previous operation
Cranioplasty is feasible according to doctor's evaluation
Patients must agree to participate in this clinical trial and the informed consent is signed by patients themselves or next of kin on behalf of the patient.
Manifestations of intracranial hypertension or untreated hydrocephalus
Poor healing of skin wound
Intracerebral infection or intracerebral hematoma is not cured
Patients with operational contradictions, for example, poor general condition
Patients with skull defect
Other
Prospective
Not listed
Implant Failure
implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty.
Length of stay in hospital
The duration of hospitalization after operation.
Detailed Economic Evaluation
Total medical expense related to treatment of cranioplasty, including the costs of operations and hospitalization within 6 months post-injury.
Complications Rates
including seizure, hematoma, hydrocephalus, etc.
Glasgow coma scale (GCS)
The Glasgow coma scale (GCS) is used to assess and calculate the patient's level of consciousness.
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