Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
Recruiting
Observational Study
Skull Defect
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Observational
- Participants needed
- 358 (estimated)
- Sponsor
- RenJi Hospital · Other
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About This Trial
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 n…
Trial Locations
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Eligibility Criteria
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 part…
Contacts