Clinical Study to evaluate clinical efficacy of patent specific cranial prothesis fabricated using 3-D Printed Model.
Not Applicable
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/08/035575
- Lead Sponsor
- Department of Biotechnology Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All patients between the age of 18 and 70 years who have undergone decompressive craniectomy for trauma or stroke where autologous bone flap is not available for cranioplasty.
Exclusion Criteria
1 Patient with a previous allergy to polymethyl methyacrylate.
2 Pregnant women and children.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cranial index of symmetry, incidence of Infection and allergy, other complications.Timepoint: After Cranioplasty 1, 3, 6, 12 months.
- Secondary Outcome Measures
Name Time Method eurological improvementTimepoint: After Cranioplasty 1, 3, 6, 12 months.;Patient health and other condition before and after the <br/ ><br>surgery.Timepoint: Patient will be evaluated for 12 months