Clnical study of porous cranioplastic implant
Phase 1
Completed
- Conditions
- Postoperative aesthetics,patient satisfaction,firmness of the implant and reactions to the implant are assessed.
- Registration Number
- TCTR20151118002
- Lead Sponsor
- ational Science and Technology Development Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Patients who has skull defect resulted from any causes and has indication for cranial reconstruction.
Exclusion Criteria
- Patients who has skull infection within 1 year.
- Patients who has the time between craniectomy and recruitment less than 3 months.
- Patients who receive radiation therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance of prefabricated implant as cranioplasty Intraoperative, Immediate, 2, 6, 12, 24 months post-operative Observation, Palpation, CT evaluation
- Secondary Outcome Measures
Name Time Method Safety of implant Immediate, 2, 6, 12, 24 months post-operative Clinical evaluation
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie tissue integration of porous cranioplastic implants in cranial defect repair?
How does the customized porous implant compare to standard autografts in postoperative aesthetics and patient satisfaction outcomes?
Which biomarkers correlate with successful osseointegration and long-term firmness of biomaterial-based cranioplastic implants?
What adverse events are associated with porous biomaterial implants in cranial surgery, and how are they managed clinically?
What combination therapies or alternative biomaterials (e.g., PCL, PLA) are being explored for cranial defect reconstruction in phase I trials?