Trials / Recruiting
RecruitingNCT05416684
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 358 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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 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
Timeline
- Start date
- 2024-11-07
- Primary completion
- 2027-09-30
- Completion
- 2027-09-30
- First posted
- 2022-06-13
- Last updated
- 2024-11-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05416684. Inclusion in this directory is not an endorsement.