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CTRI Number  CTRI/2024/07/070386 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 05/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Method of cast application ]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of application of Final post tenotomy cast in clubfoot patients with one side receiving standard technique cast and other side receiving reinforced cast with reinforcement at knee and foot  
Scientific Title of Study   Comparison of Reinforced and Standard cast for post tenotomy Clubfoot Children 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Agarwal  
Designation  Specialist and head  
Affiliation  Chacha Nehru Bal Chikitsalaya  
Address  Department of pediatric orthopedics Chacha nehru Bal chikitsalaya, geeta colony New Delhi

East
DELHI
110031
India 
Phone  8595919304  
Fax    
Email  anilrachna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kishmita Sachdeva 
Designation  fellow pediatric orthopedics  
Affiliation  Chacha Nehru Bal Chikitsalaya  
Address  room no 39, Department of pediatric orthopedics Chacha nehru Bal chikitsalaya, geeta colony, New Delhi, India

East
DELHI
110031
India 
Phone  9915883435  
Fax    
Email  kishmitasachdeva@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Agarwal  
Designation  Specialist and head  
Affiliation  Chacha Nehru Bal Chikitsalaya  
Address  Department of pediatric orthopedics Chacha nehru Bal chikitsalaya, geeta colony New Delhi


DELHI
110031
India 
Phone  8595919304  
Fax    
Email  anilrachna@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric Orthopeadics Chacha Nehru Bal Chikitsalaya ,Geeta Colony, New Delhi, India Pincode : 110031 
 
Primary Sponsor  
Name  Chacha Nehru Bal Chikitsalaya  
Address  Room no. 39 Department of Pediatric Orthopedics, Chacha nehru Bal Chikitsalaya , geeta colony, New Delhi, 110031 
Type of Sponsor  Research institution and hospital 
 
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 Anil Agarwal   Chacha Nehru Bal Chikitsalaya Govt. Of NCT of Delhi. Geeta Colony, Delhi -110031  Room no. 39 Department of pediatric orthopaedics, Chacha Nehru Bal Chikitsalaya Govt. Of NCT of Delhi. Geeta Colony, Delhi -110031
East
DELHI 
8595919304

anilrachna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , Chacha Nehru Bal Chikitsalaya   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  Application of reinforced cast   additional slab application on one foot and knee in post tenotomy cast in clubfoot patients only once  
Comparator Agent  Application of standard cast   No additional reinforcement will be done for the applied one cast  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Idiopathic clubfoot children with bilateral clubfeet undergoing Achilles tenotomy for correction of ankle equinus 
 
ExclusionCriteria 
Details  1) Syndromic, neurological, complex, previously operated and relapsed clubfeet
2)Clubfoot children where tenotomy is not required for correction of ankle equinus or Achilles tenotomy is required for only one foot

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare cast characteristics of reinforced and standard casts in post tenotomy clubfoot patients   3 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1) To compare ankle dorsiflexion clinically prior to cast application and on removal

2) To evaluate gap index and ankle dorsiflexion in the post tenotomy casts radiologically
 
3 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   16/07/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Ponseti method consists of specific technique of manipulation and cast application with foot in corrected position. Correction of equinus deformity in clubfoot patients requires percutaneous tendoachilles tenotomy followed by cast application in complete dorsiflexion to maintain the correction achieved for 3 weeks. Since this cast may be subjected to physiological activities of an active child, it may lose its integrity, bringing change in cast characteristics leading to loss of correction achieved at application. Also it is observed at 3 weeks follow up the breakage of cast at knee and ankle region leading to loss of ankle dorsiflexion. There are no previous studies to determine the cast characteristics to preserve ankle dorsiflexion so our study plans to explore this aspect of Ponseti casting in active child.

Aim: Compare cast characteristics for reinforced and standard casts for post tenotomy clubfoot children on removal

Objectives: 1) To compare the cast characteristics for reinforced casts and standard casts in post tenotomy patients

2 ) To compare ankle dorsiflexion clinically prior to cast application and on removal

 

3) To evaluate gap index and ankle dorsiflexion in the post tenotomy casts radiologically

 

Methodology : 30 bilateral idiopathic clubfoot children meeting the inclusion and exclusion criteria who are undergoing tenotomy will be enrolled. Post tenotomy clinical dorsiflexion will be measured and casts will be applied according to standard technique in one limb and reinforcement will be done at knee and planter aspect of foot in the other after placement of radiopaque markers. Lateral foot radiographs will be obtained and gap index, radiological dorsiflexion and cast dorsiflexion will be measured.

Outcome Measures: Cast characteristics will be recorded in terms of moulding, flexion at knee, dorsiflexion at ankle and extent after application. Lateral foot radiographs will be obtained and gap index, radiological dorsiflexion and cast dorsiflexion will be measured. At 3 weeks follow up change in cast characteristics in terms of breakage at knee and ankle, slippage and weight will be recorded. The loss of clinical dorsiflexion (if any) after cast removal will be calculated and correlated with the cast characteristics to determine the effect of reinforcement of cast and preservation of ankle dorsiflexion.

 
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