Status:
RECRUITING
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
Lead Sponsor:
RenJi Hospital
Conditions:
Skull Defect
Eligibility:
All Genders
18-65 years
Brief Summary
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 infec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT05416684
Start Date
November 7 2024
End Date
September 30 2027
Last Update
November 12 2024
Active Locations (1)
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1
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127