Actively Recruiting
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
Led by RenJi Hospital · Updated on 2024-11-12
358
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
Z
Zhiyi Zhou
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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