| 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
|
|
|
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
|
|
|
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. |