| CTRI Number |
CTRI/2024/08/073123 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study between Accelerated and Standard Ponseti Cast in the Management
Of Idiopathic CTEV |
|
Scientific Title of Study
|
Accelerated versus Standard Ponseti Cast in the Management of Idiopathic Congenital Talipes Equinovarus at a Tertiary Care Centre: A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archit Garg |
| Designation |
Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Orthopaedics, Armed Forces Medical College, Wanowrie
Pune MAHARASHTRA 411040 India |
| Phone |
8390294419 |
| Fax |
|
| Email |
architgarg93@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of orthopaedics, Military Hospital, Khadki
Pune MAHARASHTRA 411003 India |
| Phone |
9836440044 |
| Fax |
|
| Email |
saurabhxyz56@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of orthopaedics, Military Hospital, Khadki
Pune MAHARASHTRA 411003 India |
| Phone |
9836440044 |
| Fax |
|
| Email |
saurabhxyz56@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Wanowrie, Pune (Maharashtra)-411040 |
|
|
Primary Sponsor
|
| Name |
Archit Garg |
| Address |
Department of Orthopaedics, Armed Forces Medical College, Wanowrie, Pune (Maharashtra)-411040 |
| Type of Sponsor |
Other [Self] |
|
|
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 Archit Garg |
Hospital |
Command Hospital Southern Command Pune MAHARASHTRA |
8390294419
architgarg93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research Cell and Institution Ethics Committee, Armed Forces Medical College, Pune-411040 |
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 |
Accelerated Ponseti Cast |
Standard Ponseti cast for Arm-1 and Accelerated Ponseti cast for Arm-2 |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
All infants and toddlers under the age of two with idiopathic club foot |
|
| ExclusionCriteria |
| Details |
1. Children with other coexisting congenital bone or other system anomalies
2. History of previous conservative or surgical intervention
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the TIME TAKEN FOR COMPLETE deformity correction (Pirani score of zero) of idiopathic Congenital Talipes Equinovarus by Accelerated Ponseti method with that of Standard Ponseti method in children less than 2 years |
Deformity correction of idiopathic Congenital Talipes Equinovarus by Accelerated Ponseti method will be checked after every 5 days and by Standard Ponseti method after every 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2024 |
| Date of Study Completion (India) |
03/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Congenital
Talipes Equinovarus Varus (CTEV) also known as clubfoot is one of the most
common and complex developmental pediatric foot deformity with a reported
incidence of 0.5-2 cases per 1000 live births (1). With a
male to female ratio of 2:1, bilateral deformity is seen in around 50% of
cases. In unilateral cases, the right foot is the most commonly affected than
left foot (2).
CTEV
is characterized by adduction, varus, equinus, and cavus deformities of the
foot. The first written record of clubfoot treatment is found in the works of
Hippocrates from around 400 BC. Hippocrates was the first to advocate
orthopedic treatment of clubfoot by gentle manipulation and bandaging (3).
Nicholas Andry (1743) in his “Orthopaedia†called the deformity as pedes
equinus resembling the foot of horse. Although the exact etiology of CTEV
remains debated, the consensus favors multiple genetic and environmental risk
factors that play varying levels of contributing roles in the clinical
manifestations of CTEV (4).
In
the 1960s, Dr. Ignacio Ponseti devised his method of conservative treatment of
CTEV, which started from the age of one day and was based on the fundamentals
of kinematics and pathoanatomy of the deformity and successfully realigning the
clubfoot in infants without any extensive and major surgeries (5). The Conventional Ponseti method uses serial
application of weekly above knee plaster casts to gradually correct the
deformity, using a strictly defined sequence of molded plaster changes. The
last deformity to be corrected is equinus, which often requires a Percutaneous
Tendoachilles tenotomy followed by a final plaster. This final plaster is
removed after three weeks and foot abduction braces are given to the child
which are to be worn for twenty-three hours per day for three months and
thereafter for twelve hours at night, till the age of three years. Classic
Ponseti method involves weekly plaster change with gradual abduction of foot (6).
In accelerated Ponseti method, the manipulation method remains the same but
plaster is changed two or three times a week (7).
This
study is being done with an aim to determine effectiveness of a shorter
duration of treatment which has obvious advantages in a country like India
where parents have to travel long distances to bring their children for plaster
changes and for follow up at health centre. |