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.
Study Type
OBSERVATIONAL
Enrollment
358
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGImplant 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.
Time frame: Within 12 months
Length of stay in hospital
The duration of hospitalization after operation.
Time frame: Within 2 months post-operation
Detailed Economic Evaluation
Total medical expense related to treatment of cranioplasty, including the costs of operations and hospitalization within 6 months post-injury.
Time frame: Within 6 months post-operation
Complications Rates
including seizure, hematoma, hydrocephalus, etc.
Time frame: 3, 6, and 12 months
Glasgow coma scale (GCS)
The Glasgow coma scale (GCS) is used to assess and calculate the patient's level of consciousness.
Time frame: 3, 6, and 12 months
Glasgow outcome scale (GOS)
Time frame: 3, 6, and 12 months
Mini-Mental State Examination score (MMSE)
Time frame: 3, 6, and 12 months
Appearance Satisfaction
Questionnaire was used to investigate patients' satisfaction with the appearance of cranioplasty.
Time frame: 6 months
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