| CTRI Number |
CTRI/2018/09/015680 [Registered on: 11/09/2018] Trial Registered Prospectively |
| Last Modified On: |
15/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
3d printed acrylic cranioplasty-A Pilot Study to Evaluate the Implant Properties, Safety Profile and Clinical Efficacy of Cranioplasty with Human Subject-Specific Acrylic Prosthesis Using 3D Printed Cranium Model |
|
Scientific Title of Study
|
: A study to evaluate the Clinical efficacy of indegineously produced, 3D printed patient specific acrylic cranial prosthesis in decompressive craniectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANIRUDDHA TEKKATTE JAGANNATHA |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical college |
| Address |
OPD no 107 Dept of neurosciences 1st floor
Ramaiah Memorial Hospital
NEW BEL road
Bangalore
KARNATAKA
560054
India |
| Phone |
08040503199 |
| Fax |
|
| Email |
anirudhbmc@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
ANIRUDDHA TEKKATTE JAGANNATHA |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical college |
| Address |
OPD no 107 Dept of neurosciences 1st floor
Ramaiah Memoria Hospital
NEW BEL road
Bangalore
KARNATAKA
560054
India |
| Phone |
08040503199 |
| Fax |
|
| Email |
anirudhbmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
ANIRUDDHA TEKKATTE JAGANNATHA |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical college |
| Address |
OPD no 107 Dept of neurosciences 1st floor Ramaiah Memorial Hospital
NEW BEL road
Bangalore
KARNATAKA
560054
India |
| Phone |
08040503199 |
| Fax |
|
| Email |
anirudhbmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RAMAIAH MEDICAL COLLEGE |
| Address |
NEW BEL road
BANGALORE
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| aniruddha t jagannatha |
RAMAIAH MEDICAL COLLEGE |
1st floor 107 neurosciences
Ramaiah Memorial Hospital
New BEL road 54
Bangalore
KARNATAKA |
08040503199
anirudhbmc@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College |
Approved |
| Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, (2) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3d printed acrylic cranioplasty flap |
for patients who had decompressive craniectomy for stroke or head injury |
| Comparator Agent |
hand molded acrylic bone plap cranioplasty-standard of care |
previous cases |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
all patients who have undergone decompressive fronto temporoparietal craniectomy, coming for cranioplasty will be included
|
|
| ExclusionCriteria |
| Details |
infection at the operative site
pregnant women
associated spinal cord injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cosmesis at the operative site,
Rate of infection at the operative site and
any other complications |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cosmesis |
6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/09/2018 |
| Date of Study Completion (India) |
13/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
the semi-crystalline PMMA implants were inserted in 10 patients. Cranial defect size ranged from 9.9-14.8cms. seven patients had traumatic brain injury and three had spontaneous ICH.casted PMMA flap had an average hardness of 160 MPa and tensile strength of ( 30.7+-3.9)MPa.one patient had infection requiring removal of acrylic flap. no hypersensitivity reaction noted in any patients. A cranial index of symmetry( CIS) of (94.5+- 3.9)% was achieved suggesting a good cosmetic outcome. |