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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.

 
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