| CTRI Number |
CTRI/2012/12/003179 [Registered on: 04/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
04/07/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [hydroxyapetite nanobead implants] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Antibiotic loaded ceramic nanobeads for bone infection |
|
Scientific Title of Study
|
Use of nano-bead hydroxyapatite implants in infected open fractures, failed implant surgeries and osteomyelitis for defect management and local delivery of appropriate antibiotics. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vrisha Madhuri |
| Designation |
Professor and Head |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE, VELLORE |
| Address |
Dr. Vrisha Madhuri, Head of the department, Paediatric Orthopaedic Unit, Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2284388 |
| Fax |
|
| Email |
madhuriwalter@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrisha Madhuri |
| Designation |
Professor and Head |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE, VELLORE |
| Address |
Dr. Vrisha Madhuri, Head of the department, Paediatric Orthopaedic Unit, Christian Medical College, Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2284388 |
| Fax |
|
| Email |
madhuriwalter@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrisha Madhuri |
| Designation |
Professor and Head |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE, VELLORE |
| Address |
Dr. Vrisha Madhuri, Head of the department, Paediatric Orthopaedic Unit, Christian Medical College, Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2284388 |
| Fax |
|
| Email |
madhuriwalter@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| External Funding will be provided by SriChitra Tirunal Institute of medical Sciences from their internal resources |
|
|
Primary Sponsor
|
| Name |
Shri Chitra Tirunal Institute of Medical Sciences |
| Address |
BMT wing, Poojapura, Trivendrum |
| Type of Sponsor |
Government 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 |
| DR VRISHA MADHURI |
Paediatric orthopaedic unit |
Dept of orthopaedics, Christian Medical College, Vellore
Vellore
TAMIL NADU |
0416-2282171
madhuriwalter@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review Board, CMC,Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteomyelitis and infected fractures and non-unions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antiobitic loaded nanobeads |
Culture specific antibiotics will be loaded onto the bioceramic nanobeads and inserted into bone defects created after debridement/ excision of the infected area of the bone |
| Comparator Agent |
not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Children with pyogenic bone infections and infected non-unions |
|
| ExclusionCriteria |
| Details |
Children who cannot be followed up for one year on a regular basis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Major adverse effect such as – Allergic reactions
|
Major adverse effect such as – Allergic reactions
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Eradication of infection and improvement in bone healing
|
upto 2 years |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
06/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chronic osteomyelitis
is treated by surgical debridement and antibiotics. Historically bone cement
beads loaded with antibiotics were used in treatment as they allowed a high
local concentration of antibiotics with minimal systemic levels. The
disadvantages were the need for a second surgery to remove the cement beads and
since the bone cement sets by an exothermic process releasing heat, only heat
stable antiobiotics could be used. We propose to use ceramic (hydroxyapatite)
nanobeads developed by the Sri Chitra Thirunal Institute in chronic
osteomyelitis in children. The theoretical advantages are the fact that any
antibiotic can be added as no heat is released, the nanobeads are biodegradable
and so no second surgery is needed. Moreover these beads can be used to fill
bone defects when they co-exist. These beads have been used anecdotally before.
We propose to do a pilot study to check the safety and feasibility of these
beads in chronic osteomyelitis in children so as to plan a future clinical
trial on the same. |