| CTRI Number |
CTRI/2019/02/017604 [Registered on: 12/02/2019] Trial Registered Prospectively |
| Last Modified On: |
07/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of correction achieved in Clubfoot by Spring distractors and Manual distractors using External fixator. |
|
Scientific Title of Study
|
Management of Clubfoot by Joshis External Stabilizing System.A comparison between Spring distractors and Manual distractors. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharath Kowshik |
| Designation |
Post Graduate Resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Orthopedics
AIIMS, Raipur
Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9986826839 |
| Fax |
|
| Email |
sharathkowshik94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bikram Keshari kar |
| Designation |
Associate professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Orthopedics
AIIMS, Raipur
Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8249122014 |
| Fax |
|
| Email |
drbikramkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharath Kowshik |
| Designation |
Post Graduate Resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Orthopedics
AIIMS, Raipur
Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9986826839 |
| Fax |
|
| Email |
sharathkowshik94@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS RAIPUR
CHHATTISGARH |
|
|
Primary Sponsor
|
| Name |
AIIMS RAIPUR |
| Address |
AIIMS RAIPUR
Chhattisgarh |
| Type of Sponsor |
Research institution |
|
|
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 Sharath Kowshik |
AIIMS RAIPUR |
Department of Orthopedics
Faculty room no.10
AIIMS RAIPUR
Raipur
CHHATTISGARH |
9986826839
sharathkowshik94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q660||Congenital talipes equinovarus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Management of clubfoot by Joshis external stabilizing system with spring distractors |
Tibiocalcaneal and calcaneometatarsal distractors distracted by preloaded springs in each distractors. |
| Intervention |
Management of clubfoot by Joshs external stabilizing system with manual distractors. |
Tibiocalcaneal and calcaneometatarsal distractors are distracted manually at controlled rate . |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Neglected, resistant, syndromic clubfoot.
Not responding to serial cast manipulation. |
|
| ExclusionCriteria |
| Details |
Patients unfit for surgery.
Patients refusing surgery.
Patients with multiple Congenital limb abnormalities. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Good to Excellent reults as per international clubfoot group scores |
Follow up for 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Technical problem and complications arising during JESS usage |
Follow up for 6 month |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Clubfoot is one of the oldest and commonest deformities affecting children. Severe clubfoot including neglected,recurrent and resistant forms cannot be managed by conservative methods and need surgical interventions. Surgery for Clubfoot has its own disadvantages. It is invasive and leads to scarring. Foot becomes rigid with soft tissue surgery and bony operations can make the foot even more smaller. To avoid it, a simple alternative is to use JESS and distractor components based on principle of controlled differential fractional distraction histogenesis. This is a percutaneous technique with minimal scarring allowing gradual distraction of soft tissues and align all the joints of foot so as to bring corrections of all aspects of deformity simultaneously. In this study, JESS fixator which is indigenous , less cumbersome , non bulky , economical and easy to apply. Latest addition in JESS assembly is spring distractor which utilise restoring force of the compressed spring to get desired distraction instead of daily manual distraction. Both manual and spring distractors for the correction of Clubfoot are acceptable methods. We are doing this study to find out which distraction sytem gives better and early correction and also is patient and user friendly.
|