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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Primary outcome measure(s)
Implant Failure — Within 12 months implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty.
Trial sites (1)
Facility
City
Region
Status
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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