| CTRI Number |
CTRI/2025/02/081138 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting the course of treatment in children with clubfoot deformity with Pirani scoring system |
|
Scientific Title of Study
|
Predicting The Treatment Course Of Clubfoot By Pirani Scoring System : A Prospective Evaluation In The Department Of Physical Medicine And Rehabilitation, Sawai Mansingh Medical College, Jaipur, Rajasthan. |
| 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 KESHAV DEV |
| Designation |
PROFESSOR |
| Affiliation |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS, JAIPUR, RAJASTHAN |
| Address |
Department of Physical Medicine and Rehabilitation, SMS Medical
college and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Department of Physical Medicine and Rehabilitation, SMS Medical
college and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828141092 |
| Fax |
|
| Email |
kdgupta092@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AISWARYA P |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS, JAIPUR, RAJASTHAN |
| Address |
Department of Physical Medicine and Rehabilitation, SMS Medical
college and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Department of Physical Medicine and Rehabilitation, SMS Medical
college and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
8547147010 |
| Fax |
|
| Email |
aiswaryapremkumar7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AISWARYA P |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS, JAIPUR, RAJASTHAN |
| Address |
Department of Physical Medicine and Rehabilitation, SMS Medical
college and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Department of Physical Medicine and Rehabilitation, SMS Medical
college and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
RAJASTHAN
302004
India |
| Phone |
8547147010 |
| Fax |
|
| Email |
aiswaryapremkumar7@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS, JAIPUR,
RAJASTHAN, INDIA. PIN: 302004 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS |
| Address |
JLN MARG, ADARSH NAGAR, JAIPUR, RAJASTHAN, INDIA. PIN: 302004 |
| Type of Sponsor |
Government medical college |
|
|
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 AISWARYA P |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS, JAIPUR, RAJASTHAN |
Department of Physical Medicine and Rehabilitation, SMS Medical
college and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN |
8547147010
aiswaryapremkumar7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS, JAIPUR, RAJASTHAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q660||Congenital talipes equinovarus, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
not applicable |
| Intervention |
Ponseti Serial casting technique |
During The initial visit of a child with foot deformity, the treating clinician assess the
deformity of foot, followed by a thorough history taking and physical examination.
Identification of the cavus, adductus, varus and equinus confirms the diagnosis of clubfoot. All
the cases of clubfoot meeting the inclusion criteria will be included in this study. After
explaining the treatment plan and outcomes, patients willing to participate in the study would
be identified. Then by obtaining a written inform consent, basic demographic characteristics
like age, sex of the child, consanguinity of marriage of parents, laterality of the foot and the
Pirani clubfoot scoring will be done for each foot and documented in the performa. After
evaluation, each of the 6 clinical signs will be scored according to the severity following which,
total midfoot score, hindfoot score and total score of each foot will be recorded in the proforma.
This will be followed by manipulation and casting which would be performed by a
trained PMR specialist according to the Ponseti technique. Following cast application, toe
movement, colour and sensations would be checked and strict instructions would be given to
the caretakers to monitor the foot regularly. In case of any abnormality, it is advised to get the
cast removed immediately. Children would be called weekly, cast removed and reassessment
would be performed by the same treating PMR specialist and further decision regarding repeat
cast or bracing or Tendoachillies tenotomy would be made. After achieving 70 degrees of
abduction and correction of heel varus, if ankle dorsiflexion remained 10 degrees,
percutaneous tenotomy would be performed under local anaesthesia. Cast will be applied after
tenotomy in full abduction and dorsiflexion for three weeks. After achieving complete
correction, either with manipulation and serial casting alone or along with a percutaneous
tenotomy, a custom-made Denis brown splint with 70 degrees external rotation on the affected
foot and 40 degrees external rotation on the normal foot and 15 degrees bend of the connecting
bar to maintain dorsiflexion would be given. The size of the splint was determined prior to
tenotomy so that the brace could be applied immediately after cast removal. The brace was
advised to be worn full time for the first three months and then to use the brace for 12 hours at
night and two to four hours in the day for a total of 14 to 16 hours during the 24-hour period
until the child was 3 to 4 years of age. During each visit, the corrected foot was examined in
detail and strict bracing protocol was advised. Follow-up of minimum one year will be done
for all cases.11 Initial Pirani score, number of serial casts applied, Pirani score at the time
complete achievement of correction would be recorded systematically by the same trained
resident doctor |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with idiopathic clubfoot presenting to the outpatient department of
Physical Medicine and Rehabilitation, Sawai Mansingh Medical College,
Jaipur, Rajasthan.
2. Children upto the age of 1 year.
3. Willing to participate in follow up study |
|
| ExclusionCriteria |
| Details |
1. Syndromic children
2. Clubfoot associated with neurological pathology
3. Clubfoot with any previous intervention or surgery
4. Atypical or complex clubfoot |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Pirani score
2. Total number of casts
3. Age of the child |
Every week after each casting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Pirani score |
At each week post intervention till deformity correction |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
04/03/2025 |
| 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="1"
Months="0"
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
|
Through a prospective interventional study, we aim to find out the role of initial Pirani score at the time of presentation in predicting the total number of casts and the requirement of tenotomy for clubfoot deformity correction, along with the role of age at presentation of the child in treatment course. |