Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）

Study Overview
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Brief Summary
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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.

Official Title
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A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy

Conditions
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Skull Defect

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEEK Group<br> | |
| Titanium Mesh Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital | The duration of hospitalization after operation. | 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. | Within 6 months post-operation | 
| Complications Rates | including seizure, hematoma, hydrocephalus, etc. | 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. | 3, 6, and 12 months | 
| Glasgow outcome scale (GOS) |  | 3, 6, and 12 months | 
| Mini-Mental State Examination score (MMSE) |  | 3, 6, and 12 months | 
| Appearance Satisfaction | Questionnaire was used to investigate patients' satisfaction with the appearance of cranioplasty. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skull Defect, Epilepsy, Infections