To,

The Member Secretary,

Institutional Ethics Committee,
Old Administrative Block,
Behind Brown Hall,
King George’s Medical University,
Lucknow, U.P.

THROUGH PROPER CHANNEL

Subject: Request for ethical approval of the thesis project

Respected sir,

I, hereby, request you to have my thesis entitled “ CLINICAL OUTCOME OF

IDIOPATHIC CONGENITAL TALIPES EQUINOVARUS TREATED WITH
PONSETI METHOD” registered for M. Ch. (Pediatric Orthopedics) examination of
King George’s Medical University to be held in 2026.
The necessary particulars and proforma along with the recommendations of Chief
Supervisor and Co-supervisors are enclosed herewith for necessary action.

Thanking you.

Yours sincerely
Dr. Nitin Jeenjwadia
Senior Resident-1
Dept. Of Pediatric Orthopedics
King George’s Medical University, Lucknow
 King George’s Medical University, UP, Lucknow
Scientific Review Committee
Department of Pediatric Orthopedics

Date: …………….
Members Present:
S.No. Name of Faculty Designation Signature
1.
2.
3.
4.
5.

The proposal entitled: “CLINICAL OUTCOME OF IDIOPATHIC CONGENITAL

TALIPES EQUINOVARUS TREATED WITH PONSETI METHOD”

Presented by: Dr. Nitin Jeenjwadia

The committee reviewed the proposal and comments are as given below:
Heading Specific comment
A Background & Rationale
B Hypothesis & Objectives
C Methodology
(Study/Design/Data Collection/Sample Size/Data
analysis plan
D Competency of Investigating team
E Budget
F Data collection instruments
G Informed consent form (Patient information sheet &
consent form)
Decision:
(1) The proposal is scientifically sound can be forwarded for ethical review /Or
(2) Proposal needs revision on the points indicated below:
(i)
(ii)
Signature of Chairperson

KING GEORGE'S MEDICAL UNIVERSITY, UP, LUCKNOW

FORM TO BE FILLED BY THE PRINCIPAL INVESTIGATOR (PI)
FOR SUBMISSION TO INSTITUTIONAL, ETHICS COMMITTEE (IEC)

* Ref. Code No. of IEC:

to be filled by Office of IEC
 PROPOSAL TITLE:

“CLINICAL OUTCOME OF IDIOPATHIC CONGENITAL TALIPES EQUINOVARUS

TREATED WITH PONSETI METHOD”

Name, Designation Email ID Signature

& Qualifications Departmental Tel
No.

Principal DR. NITIN Mob: 9414856330

Investigator JEENJWADIA
Department of Email:
Pediatric jeenjwadia90@gm
Orthopedics ail.com
King George’s
Medical University
Lucknow

Chief Supervisor Dr Shakeel A Mob: 9451387752

Qidwai
Additional Professor Email:
Dept. of Paediatric
Orthopaedic, King
George’s Medical
University
Lucknow

Co Supervisor Dr Vikas Verma Mob – 7839317083

Associate Professor Email:
HOD surgeonvikas@yaho
Dept. of Paediatric o.co.in
Orthopaedic, King
George’s Medical
University
Lucknow

Co Supervisor Dr Suresh Chand Mob: 8826533834

Assistant Professor Email:
Dept. of Paediatric sureshdocucms@gm
Orthopaedic, King ail.com
George’s Medical
 University
Lucknow

PROPOSAL TITLE :- “CLINICAL OUTCOME OF IDIOPATHIC CONGENITAL

TALIPES EQUINOVARUS TREATED WITH PONSETI METHOD”

Name and Role Signature

 Designation
Dr. Nitin Substantial contribution to
jeenjwadia the conception, data
Principal SR-1 collection, data compilation
Investigator Dept Of Paediatric and thesis writing
Orthopaedic

Chief Dr Shakeel A
Qidwai Design, case selection, case
Supervisor Additional management, interpretation
Professor of results and data,
Dept. of Paediatric supervision and final
Orthopaedic, King approval of thesis writing
George’s Medical
University
Lucknow

Co Supervisor Dr Vikas Verma

Associate Professor Supervision throughout the
HOD study Design, case
Dept. of Paediatric selection, case
Orthopaedic, King management, interpretation
George’s Medical of results
University
Lucknow

Co Supervisor Dr Suresh Chand Supervision throughout the

Assistant Professor study Design, case
Dept. of Paediatric selection, case
Orthopaedic, King management, interpretation
George’s Medical of results
University
Lucknow

Sponsor Information – SPONSOR WILL NOT BE REQUIRED

1. Indian a) Government Central State  Institutional 

b) Private 

2. International a) Government Private UN Agencies

3. Industry a) National Multinational

4. Contact address of sponsor

- Not applicable -

5. Budget - Not required-

1. Type of study Epidemiological Basic Sciences  Behavioral 

Clinical  Single Centre  Multicentric

2. Status of review New Revised

3. Clinical Trials – NOT APPLICABLE AS THE STUDY IS NOT A CLINICAL TRIAL

Drug/Vacancies/Device/Herbal Remedies
i. Does the study involve use of
Drugs  Devices Vaccines
Indian systems of Medicines / or Alternate systems of Medicine Any other None

ii. Is it approved and marketed - NOT APPLICABLE -

In India UK & Europe USA
Other countries, specify

iii. Does it involve a change in use, dosage, route of administration? – Not applicable Yes  No 
if yes, whether DCGI’s/Any other Regulatory Authority’s permission obtained? Yes  No 
If yes, copy of permission attached. Yes  No 

iv. Is it an Investigational New Drug? NOT APPLICABLE Yes  No 

If yes,
a. Investigator's Brochure enclosed Yes  No 
b. Preclinical studies data available (if yes, provide summary) Yes  No 
c. Clinical studies data available (if yes, provide summary) Yes  No 
d. Clinical study is Phase IPhase II Phase III Phase IV  N/A 
e. DCGI’s permission obtained Yes  No 
If yes, copy of letter enclosed Yes  No 

4. Brief description of the proposal-aim(s) and objectives, justification for study, methodology
describing the potential risks and benefits, outcome measures, statistical analysis and whether
it is of national significance with rationale (Attach sheet with maximum 500 words)

- SHEET AND EXECUTIVE SUMMARY ARE ATTACHED–

5. Subject selection
i. Number of subjects: All patients meeting the exclusion and inclusion criteria who presenting to OPD
and IPD of the department of Paediatric Orthopaedics during the duration 1 Year Study
ii. Duration of a) Study: One Year b) Subject participation – One Year
iii. Will subjects from both sexes be recruited Yes  No 
iv. Inclusion/exclusion criteria given Yes  No 
v. Type of subjects Volunteers  Patients 
vi. Vulnerable subjects Yes  No 
(Tick the appropriate boxes)
Pregnant Women  Children  Elderly 
Fetus  Illiterate  Handicapped 
Terminally ill  Seriously ill  Mentally Challenged 
Economically & socially backward  Any other 

vii. Special group subjects Yes  No 

(Tick the appropriate boxes)
Captives  Institutionalized  Employees 
Students  Nurses / Dependent  Armed Forces 
Any other  Staff 
6. Privacy and confidentiality - WILL BE MANTAINED
i. Study Involves Direct Identifiers 
Indirect Identifiers/Coded 
Completely Anonymised / Delinked 
ii. Confidential handling of data by staff Yes  No
7. Use of biological / hazardous materials – The study doesn’t involve biological/hazardous
material
i. Use of fetal tissue of aborts. If yes provide details Yes  No
ii. Use of organs or body fluids. If yes provide details Yes  No
iii. Use of recombinant / gene therapy products Yes  No
if yes, has Institutional Biosafety Committee approval for rDNA
products been obtained? Yes  No
iv. Use of pre-existing/stored/left over samples Yes  No
v. Collection for banking / future research Yes  No
vi. Use of ionizing radiation / radioisotopes Yes  No
If yes, has Institutional Biosafety Committee approval for
Radioactive Isotopes been obtained? Yes  No
vii. Use of Infectious / biohazardous specimens Yes  No
viii. Proposal disposal of material Yes  No

ix. Will any sample collected from the patients be sent abroad? Yes  No
If yes, give details and address of collaborators
 - The study doesn’t involve any sample collection -

a. Sample will be sent abroad because (Tick appropriate box)

Facility not available in India 
Facility in India inaccessible 
Facility available but not being accessed 
If so, reasons
b. Has necessary clearance been obtained Yes  No

8. Consent * Written  Oral Audio-Visual 

i. Patient Information Sheet attached: (Tick the included elements) Yes  No

Understandable language Alternatives to participation 

Statement that study involves research Confidentiality of records 
Sponsor of study Contact information
Purpose and procedures Statement that consent is voluntary 
Risks & discomforts Right to withdraw 
Benefits Consent for future use of material biological 

Compensation for participation 

Benefits if any on future commercialization e.g.
Genetic basis for drug development 

Compensation for study related injury  -

Translation of information sheet in local language
ii. If healthy volunteers will be included, information sheet for them attached Yes  No
iii. Consent form in English  Hindi 
iv. Who will obtain consent (PI/Co-PI)  Nurse / Cousellor 
Research Staff  Any other 
* If written consent is not obtained, given reasons:

9. Will any advertising be done for recruitment of Subjects?

(Posters, flyers, brochure, websites – if so attach a copy) Yes  No
10. Risks & benefits
i. Is the risk reasonable compared to the anticipated benefits to
subjects / community / country? (No risk is anticipated) Yes  No
ii. Is there physical / social / psychological risk / discomfort? Yes  No
if yes, Minimal or no risk 
More than minimum risk 
High risk 
iii. Is there benefit a) to the subject? Yes  No
Direct Indirect 
b) to the society? Yes  No
11. Data monitoring
i. Is there a data & safety monitoring committee/Board (DSMB)? Yes  No
(Not required)
ii. Is there a plan for reporting of adverse events? (Adverse events not expected) Yes  No
if yes, reporting will be done to- Not applicable-
Sponsor  IEC  DSMB 
iii. Is there a plan for interim analysis of data? Yes  No
12. Is there compensation for injury? - (Injury not expected) Yes  No
If yes, by
Sponsor  Investigator 
Insurance Company  Any other 
13. Do you have conflict of interest? Yes  No
(Financial / Non financial)
If yes, specify
Check list for attached documents:
Project proposal – 05 copies
Curriculum Vitae of non KGMU Investigators Not required 
Brief description of proposal/summary Yes 
Copy of the Protocol / Project and questionnaire (if any) Yes 
Investigator’s Brochure Not required 
Copy of Patient information sheet & Consent form in local language Yes 
Copy of Advertisements/Information brochures Not applicable 
DCGI/DBT/BARC clearance if obtained Not required 
Copy of Insurance Policy Not required 
Copy of Clinical trial agreement Not applicable 
Copy of IEC proforma Yes 
Copy of PI undertaking Yes 
Copy of Case Report Form Not required 

Signature of PI with stamp

Date

Signature of HOD with stamp

PROJECT SUMMARY:

TITLE: “CLINICAL OUTCOME OF IDIOPATHIC CONGENITAL TALIPES

EQUINOVARUS TREATED WITH PONSETI METHOD”
Worldwide 150,000-200,000 babies with idiopathic congenital talipes equino varus (ICTEV)
are born each year and approximately 80% of them are born in the developing world with
limited access to appropriate medical care. Untreated or incorrectly treated clubfoot soon
becomes “neglected clubfoot” as the child grows older and learns to walk. Idiopathic CTEV
is a common complex congenital anomaly in 0.39-7 children per 1000 births worldwide. The
affected children have abnormal foot anatomy and biomechanics with the affected feet being
fixed in an extended, adducted position. The burden of untreated or incorrectly treated
Idiopathic CTEV negatively impacts society and should be viewed as a public health issue so
as to reduce its prevalence through early diagnosis and institution of appropriate treatment.
The goal of treatment is to achieve early and full correction of all the four deformities of the
foot, ensure that the patient has a functional, pain-free, plantigrade foot, with good mobility,
without calluses, and does not need to wear modified shoes. The treatment modalities for
Idiopathic CTEV have evolved through a series of trials to include; conservative and surgical
methods since the 18th century. [1,2] The four components of a congenital club foot are cavus,
adduction, varus, and equinus. The treatment's purpose is to address four abnormalities and
keep them corrected so that the patient can have a functional, pain-free plantigrade foot.
Various nonsurgical treatment approaches have been tried, ranging from Hippocrates'
bandages and Kite's plaster casts in 1937 to surgical treatment, but no satisfactory treatment
for achieving a functional, painless, plantigrade foot with good mobility has yet to be
established. However, as more is learned about the etiology and pathoanatomy of clubfoot,
the outcomes have improved with time. [2,3]

Kite's approach of repair has a number of flaws, according to Ignacio Ponseti. He proposed
the manipulation and serial casting approach for correcting clubfoot deformity, and his
technique had good results in 89% of the patients.[4] Ponseti's cases were evaluated by
Cooper and Dietz, who reported that 78% of the patients had excellent or good functional and
clinical outcomes after an average of 30 years of follow-up. [5] For the early and most
effective treatment of clubfoot, nonsurgical treatment using Ponseti's approach of
manipulation and serial casting with percutaneous tenotomy is now used all over the world.
Surgery is reserved only in resistant, recurrent, and cases which present at a late stage.[1,3]

Treatment with the Ponseti technique should begin as soon as possible. It features a treatment
phase that comprises weekly casting and mild massage. In most cases, a percutaneous
Achilles tenotomy is required to treat equinus. For 3 weeks, the final cast is worn with the
foot in 60° of abduction and the ankle in 15° of dorsiflexion. The correction is kept in brace
during the maintenance phase, with the foot in 70° of external rotation and 15° of
dorsiflexion. It is worn for the first 3 months for 23 hr a day and then for the next 3–4 years
while sleeping.[5]

Ponseti in the 1950´s developed a non-operative technique of management of ICTEV and

made his publication in 1963, registering excellent outcomes in terms of function. The early
treatment outcomes have kept improving since the time many surgeons began embracing the
technique about 35 years later. Ponseti suggested that treatment be evaluated solely by
palpation; however, radiography is still used by a small number of paediatric orthopedic
surgeons. Clinical examination for follow-up and monitoring of correction is subjective and
depends on clinical experience. Interobserver and intraobserver variability and erroneous
identification of abnormalities are limitations of clinical grading of club foot.[6]

Duration: 12 months

Aim and Objectives:

Aim:
• To assess the clinical outcome of Ponseti Method in idiopathic clubfoot
Objectives:
• Pirani score based, pre-correction and post-correction assessment of deformity.
• To compare pretreatment and post treatment Pirani score.
• To grade outcome as per post-correction Pirani score.

Statistical analysis:

Data will be analyzed using IBM SPSS version 20 (IBM SPSS statistics 20.0) for windows.
The demographic variables and other variables will be calculated by number and percentage.
The Wilcoxon test will be used to find a significant difference in Pirani score and functional
rating before and after treatment, and a chi-square test will be used to find an association
between sex and laterality. Correlation and a test for correlation will be used to find the
significant correlation between the Pirani score and the total number of casts. A probability
value of 0.05 will be accepted as the level of statistical significance.

Sample size:

SAMPLE SIZE:
Calculated by the formula:

n = Desired sample size, Z α = Critical value and a standard value for the corresponding level
of confidence. (At 95% CI or 5% level of significance (type-I error) it is 1.96)

Zβ = Critical value and a standard value for 80% power of test (β=20% (type-II error) it is
0.8416)

σ1= standard deviation for group1, σ2= standard deviation for group2, d = min(σ1,σ2)

Zα = 1.96 Zβ = 0.8416 σ1 = 1 σ2 = 0.5 d=0.5

Materials: The minimum sample size required for the study would be 40 (without attrition)
and 44 (in case 10 % attrition being considered) but All eligible patients meeting the
criteria for a duration of 8 months will be included in the study.

ANNEXURE: 2-RV-I/2019 (SOP-IEC-KGMU)

UNDERTAKING BY THE PRINCIPAL INVESTIGATOR
1. NAME OF THE PROJECT: “CLINICAL OUTCOME OF IDIOPATHIC CONGENITAL
TALIPES EQUINOVARUS TREATED WITH PONSETI METHOD”

2 NAME, DESIGNATION AND DEPARTMENT OF THE PRINCIPAL

INVESTIGATOR:
Dr. NITIN JEENJWADIA, SR -1, Department of Pediatric Orthopedics, KGMU,
Lucknow.
Mobile no. 9414856330 E-mail - jeenjwadia90@gmail.com

3 OTHER MEMBERS OF THE RESEARCH TEAM:

ADDL.PROF. DR Shakeel A Qidwai, Dr Vikas Verma, Dr Suresh Chand.

4. NAME AND ADDRESS OF ANY OTHER MEDICAL INSTITUTE, HOSPITAL OR

INSTITUTION WHERE PARTS OF THE STUDY WILL BE DONE – N/A

5 NUMBER OF ONGOING PROJECTS/CLINICAL TRIALS IN WHICH YOU ARE

PI – NIL
● I confirm that I will initiate the study only after obtaining all regulatory clearances.

● I will not implement any deviation from the approved protocol without prior consent of the
sponsor nature and it will be intimated to the IEC at the earliest.
● I confirm that the CO PI and other members of the study team have been informed about their
obligations and are qualified to meet them.
● I will personally supervise the study and ensure that requirements of obtaining informed
consent. and other ethical requirements under ICMR and National Regulatory Guidelines are
adhered to.
● I will maintain accurate and complete record of all cases in accordance with GCP provisions
and make them available for audit/inspection by IEC, Regulatory authorities, Sponsors or
their authorized representatives.
● I will inform the IEC and the Sponsors of any unexpected or serious adverse event at the
earliest and definitely within seven days of its occurrence.
● I will maintain confidentiality of the identity of all participating subjects and assure security
and confidentiality of study data.
● I and my colleagues will comply with statutory obligations, requirements and guidelines
applicable to such clinical studies.
● I will inform WC of the date of starting the study within 2 weeks of initiation of the trial and
submit annual progress reports and final report to Member Secretary, within 4 weeks of the
due date.

Signature of Principal Investigator

Dr. Nitin Jeenjwadia Date

PATIENT INFORMATION SHEET:

STUDY TITLE : “CLINICAL OUTCOME OF IDIOPATHIC CONGENITAL TALIPES

EQUINOVARUS TREATED WITH PONSETI METHOD”

Thank you for taking time to read this information sheet. This sheet provides an overview of
club foot (CTEV) and the care provided to children with club foot. You are being invited to
take part in a research study. Before you decide it is important for you to understand why the
study is being done and what it will involve. Please take time to read the following
information carefully and discuss it with friends, relatives and your treating physician/ family
doctor if you wish. Ask us if there is anything that is not clear or if you would like more
information.

Idiopathic CTEV is a common complex congenital anomaly in 0.39-7 children per 1000
births worldwide. The affected children have abnormal foot anatomy and biomechanics with
the affected feet being fixed in an equinus, adducted position. For the early and most
effective treatment of clubfoot, nonsurgical treatment using Ponseti approach of
manipulation and serial casting with percutaneous tenotomy is now used all over the world.
Surgery is reserved only in resistant, recurrent, and cases which present at a late stage.

You have been chosen for study because you have a child with club foot deformity and
required correction the deformity. It is up to you to decide whether or not to take part. If you
do decide to take part you will be given this information sheet to fill and sign a consent form.
If you decide to take part you are still free to withdraw at any time and without giving a
reason. This will not affect the standard of care you receive. You will be involved in the
research/trial for 1 year. You will not need to visit the doctor (or clinic) more often than for
the usual treatment. Your travel expenses will not be covered. No risks from the study are
expected. If the results get published you shall not be recognized in the document. My
contact details shall be provided to you. Your queries regarding this study are welcome. We
are very thankful for your participation.

DR. NITIN JEENJWADIA

Principal Investigator
ANNEXURE – 4

Standard Format for Executive Summary

To be submitted for Ethical Approval
(Up to 5 pages)

Title of Project: “FUNCTIONAL OUTCOME OF IDIOPATHIC CONGENITAL

TALIPES EQUINOVARUS TREATED WITH PONSETI METHOD”

INTRODUCTION AND REVIEW:

Idiopathic CTEV is a common complex congenital anomaly in 0.39-7 children

per 1000 births worldwide. The affected children have abnormal foot anatomy
and biomechanics with the affected feet being fixed in an equinus, adducted
position.
For the early and most effective treatment of clubfoot, nonsurgical treatment
using Ponseti approach of manipulation and serial casting with percutaneous
tenotomy is now used all over the world. Surgery is reserved only in resistant,
recurrent, and cases which present at a late stage.

Changulani M et al (2006) study shows the Ponseti method suggests that is is a

simple and effective method of treating congenital idiopathic club foot. (9)

Pavone V et al (2013) study shows The Ponseti method provides an excellent

outcome at follow up in the treatment of congenital idiopathic clubfoot. (10)

Madhuchandra p et al (2018) study shows severity of the deformity and the

compliance of the parents and infants with orthotic devices for maintenance of
the correction were the factors which ultimately determine the final outcome.

Parikh et al (2019) study shows that clubfoot deformity can be managed

successfully provided the technique and details of manipulation described by
Ponseti are followed strictly and patients can be followed up regularly by a team
of dedicated orthopedic surgeons. (12)

Gupta V et al (2022) study shows Ponseti method of manipulation and casting is

an excellent method for the correction of all four deformities associated with
congenital talipes equinovarus & can achieve painless, plantigrade, normal
looking foot, after proper follow-up & good compliance. (14)

REFERENCES

1. 1 Kelly DM. Congenital anomalies of the lower extremity. In: Canale ST, Beaty JH,
editors. Campbell‘s Operative Orthopaedics. 12th ed. Penslyvania: Mosby; 2013. pp.
994–1012.
2. Kite JH. Principles in the treatment of congenital clubfoot. J Bone Joint
Surg. 1939;21:595–606.
3. Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992;74:448–
54.
4. Ponseti IV, Smoley EN. Congenital clubfoot: Results of treatment. J Bone Joint
Surg. 1963;45A:261–6.
5. Cooper DM, Dietz FR. Treatment of idiopathic clubfoot. A thirty-year follow-up
note. J Bone Joint Surg Am. 1995;77:1477–89.
6. Ponseti IV. Clubfoot management. J Pediatr Orthop. 2000;20:699–700.
7. Prasad P, Sen RK, Gill SS, Wardak E, Saini R. Clinico-radiological assessment and
their correlation in clubfeet treated with postero-medial soft-tissue release. Int
Orthop. 2009;33:225–9.
8. Bhaskar A, Rasal S. Results of treatment of clubfoot by Ponseti's technique in 40
cases: Pitfalls and problems in the Indian scenario. Indian J Orthop. 2006;40:196–9
9. Changulani M, Garg NK, Rajagopal TS, Bass A, Nayagam SN, Sampath J, Bruce CE.
Treatment of idiopathic club foot using the Ponseti method. Initial experience. J Bone
Joint Surg Br. 2006 Oct;88(10):1385-7. doi: 10.1302/0301-620X.88B10.17578.
PMID: 17012432.
10. Pavone V, Testa G, Costarella L, Pavone P, Sessa G. Congenital idiopathic talipes
equinovarus: an evaluation in infants treated by the Ponseti method. Eur Rev Med
Pharmacol Sci. 2013 Oct;17(19):2675-9. PMID: 24142617.
 11. Madhuchandra P, Raju KP, Pawankumar KM, Shrinidhi IS.Functional outcome of
idiopathic congenital talipes equinovarus treated by Ponseti method: a midterm
study.Int J Res Orthop2018;4:296-301
12. Parikh K, Niravkumar P. Moradiya. Outcomes of Congenital Talipes Equinovarus
treated with Ponseti Method. International Journal of Contemporary Medical
Research 2019;6(1):A1-A5
13. Malinga RJ, Madewo G, Orwotho N, Pirani SP, Afodun AM, Masud MA. A survey
on idiopathic congenital talipes equinovarus (ICTEV) managed by the Ponseti
technique at Mulago Hospital - Uganda. Pan Afr Med J. 2021 Apr 23;38:397. doi:
10.11604/pamj.2021.38.397.26560. PMID: 34381541; PMCID: PMC8325474
14. Gupta v. Outcome of ponseti technique for the management of congenital talipes
equinovarus at a district hospital. European Journal of Molecular & Clinical
Medicine. 2022(9); ISSN 2515-8260

OBJECTIVES:
• Pirani score based, pre-correction and post-correction assessment of
deformity.
• To compare pretreatment and post treatment pirani score.
• To grade outcome as per post-correction Pirani score.

STUDY DESIGN AND METHODS:

This shall be a Single centre prospective cohort study conducted in Department of Pediatric

Orthopedics, King George Medical University, Lucknow, Uttar Pradesh. Formal ethical approval

shall be taken from the Institutional Ethics Committee, King George’s Medical University, U.P.,

and India. Written informed consent shall be obtained from all patients and/or their legal guardian.

DURATION: 12 month
STUDY SETTING
All patients with clubfoot will be assessed in Paediatric orthopaedic OPD KGMU by detailed
history taking, general and systemic examination. All demographic parameters viz. Name,
Age and Sex shall also be recorded.
Patients will be evaluated through detailed history and general physical and local
examination. Every clubfoot taken up for the study will be graded according to the Pirani
severity score. Thorough clinical examination to assess the condition of skin, extent of
deformity, muscle bulk, joint movement, and neurovascular status of the foot will be done.
Clinical grading of main deformity of clubfoot will be done as per Pirani's score. In Pirani’s
score 6 well described clinical signs of clubfoot. Three of these signs indicate primarily Hind
Foot Contracture (HFC) and three signs indicate primarily Mid Foot Contracture (MFC).
Hind Foot Contracture (HFC) - 1. Posterior crease (PC), 2. Rigid Equinus(RE), 3. Empty
Heel (EH). Mid Foot Contracture (MFC) - 1.Curved lateral border, 2.Medial crease,
3.Coverage of the talar head. Each component will be scored as 0 (normal), 0.5 (mildly
abnormal), or 1 (severely abnormal). Pirani scoring of each component and the total scores
will be maintained at each visit on a weekly interval. The least total score for all categories
combined will be 0 and the maximum score was 6.
Manipulation, casting, and Achilles tenotomy will be done with the Ponseti technique by the
same team of paediatric orthopedic surgeons. Results will be evaluated on the basis of the
posttreatment Pirani score. The final result will be graded as good, if the total Pirani score
remained zero; fair, if the total score will be 0.5–1; and poor if the total score will be more
than one.

INCLUSION AND EXCLUSION CRITERIA:

INCLUSION CRITERIA:

 All patients up to 2 years of age clubfoot, which can be unilateral or

bilateral.
EXCLUSION CRITERIA:
 Operated cases
 Syndromic club foot eg. Arthrogryposis multiplex congenita , Streeter
dysplasia
 Relapse/ Recurrent clubfoot
 Neurogenic club foot – spina bifida, meningocele, meningomyelocele
Atypical clubfoot

Ethical clearances:

Is being submitted for the same

Time Line:

Patient enrollment : 8 month

Follow up : every week for casting before correction and every month up to 3
month after application of foot abduction brace.
Statistical analysis & project submission : 4 months
Man hour to be devoted : 6 man hour in every Monday and Wednesday OPD.
 ANNEXURE: 8-RV-1/2019 (SOP-IEC-KGMU)

किंग जॉर्ज मेडिकल यूनिवर्सिटी, यूपी, लखनऊ

सूचित सहमति प्रपत्र
अध्ययन र्षक "पोंसेटी विधि से उपचारित इडियोपैथिक जन्मजात टैलिप्स
इक्विनोवर्स का नैदानिक परिणाम"

अध्ययन
संख्या______________________________________________________________
प्रधान-अन्वेषक का संपर्क विवरण: मो. नंबर 9414856330, ईमेल आईडी:
jeenejwadia90@gmail.com
विषय का पूरा नाम ______________________________________________
जन्म तिथि/आयु___________________________________________________
पता _________________________________________________________________
भाग ---- पहला

1. अध्ययन का उद्देय
य : इस अध्ययन में, हम बिना किसी पूर्व उपचार के पहले दो वर्षों
य
के भीतर हमारे सामने आने वाले बच्चों में पोंसेटी तकनीक का उपयोग करके
इडियोपैथिक क्लबफुट के नैदानिक परिणाम जानना चाहते हैं।
2. अध्ययन प्रक्रियाएँ: यदि आप अध्ययन में भाग लेने के लिए सहमत हैं, तो
निम्नलिखित प्रक्रिया होगी
- डेटा संग्रह: एक बार पंजीकृत होने के बाद आपको एक डेटा संग्रह ट भरनी होगी
जिसमें जनसांख्यिकीय जानकारी, उपचार विवरण और परिणाम शामिल होंगे।
3.अध्ययन से जोखिम: कोई नहीं
4. अध्ययन से लाभ: पैर की विकृति के सुधार में आपको सीधा लाभ होगा।
5.जटिलताएँ: कास्ट का ढीला होना, कास्ट से जुड़ी त्वचा में जलन और टेनोटॉमी के
दौरान न्यूरोवस्कुलर क्षति
6. मुआवज़ा: कोई नहीं
7. गोपनीयता: अध्ययन से संबंधित कोई भी जानकारी तब तक गोपनीय रखी जाएगी जब तक
कता
किसी कानूनी प्रक्रिया की आवयकता न हो। यदि अध्ययन का परिणाम प्रका ततशि
श्य किया
जाएगा तो प्रतिभागी की जानकारी गोपनीय रखी जाएगी।
8. प्रतिभागियों के अधिकार: प्रतिभागी को बिना कोई कारण बताए किसी भी समय अध्ययन
का हिस्सा बनने से इनकार करने का अधिकार है।
9. अध्ययन में भाग लेने के विकल्प: कोई नहीं

भाग 2
अनुमति
1 मैं पुष्टि करता हूं कि मैंने उपरोक्त अध्ययन के लिए दिनांक ___________ सूचना
पत्र को पढ़ और समझ लिया है और मुझे प्रन श्नपूछने का अवसर मिला है।
या
मुझे अन्वेषक द्वारा अध्ययन की प्रकृति के बारे में समझाया गया और प्रन श्नपूछने
का अवसर मिला
2 मैं समझता हूं कि अध्ययन में मेरी भागीदारी स्वैच्छिक है और मैं बिना कोई
कारण बताए और अपनी चिकित्सा देखभाल या कानूनी अधिकारों को प्रभावित किए बिना
किसी भी समय वापस लेने के लिए स्वतंत्र हूं।
3 मैं समझता हूं कि नैदानिक परीक्षण/परियोजना के प्रायोजक, प्रायोजक की ओर से
काम करने वाले अन्य लोग, आचार समिति और नियामक अधिकारियों को वर्तमान
अध्ययन और किसी भी आगे के शोध के संबंध में मेरे स्वास्थ्य रिकॉर्ड को देखने
के लिए मेरी अनुमति की आवयकता कता श्य
नहीं होगी। हालाँकि, मैं समझता हूँ कि तीसरे
पक्ष को जारी या प्रका ततशि
किसी भी जानकारी में मेरी पहचान उजागर नहीं की जाएगी।
4 मैं इस अध्ययन से उत्पन्न होने वाले किसी भी डेटा या परिणाम के उपयोग को
प्रतिबंधित नहीं करने के लिए सहमत हूं, बशर्ते कि सा उपयोग केवल वैज्ञानिक
उद्देयोंश्यों
के लिए हो।
5. मैं उपरोक्त अध्ययन में भाग लेने के लिए सहमत हूं।

कानूनी रूप से स्वीकार्य प्रतिनिधि के हस्ताक्षर (या अंगूठे का नि ननशा

): _____________
हस्ताक्षरकर्ता का नाम: ______________________________
तारीख:_________________________________________
विषय के साथ संबंध:________________________

जांचकर्ता का बयान:-
मैं, नीचे हस्ताक्षरकर्ता ने माता-पिता/अभिभावक को उस भाषा में समझाया है जिसे
वह अध्ययन में अपनाई जाने वाली प्रक्रियाओं और जोखिमों और लाभों को समझता
है।

अन्वेषक के हस्ताक्षर: दिनांक:

अन्वेषक का नाम:

गवाह के हस्ताक्षर: दिनांक:

`
 ANNEXURE: 9-RV-1/2019 (SOP-IEC-KGMU)

KING GEORGE’S MEDICAL UNIVERSITY, UP, LUCKNOW

INFORMED CONSENT FORM
Study Title “CLINICAL OUTCOME OF IDIOPATHIC CONGENITAL
TALIPES EQUINOVARUS TREATED WITH PONSETI METHOD”

Study Number____________________________________________________________
Contact details of Principal-Investigator: Mob. No. 9414856330, Email ID:
jeenejwadia90@gmail.com
Subject’s Full Name ____________________________________________
Date of Birth/Age_______________________________________________
Address _________________________________________________________________

PART 1
1. Purpose of the study: In this study, we want to know the clinical outcome of Idiopathic
clubfoot using Ponseti technique in children presenting to us within the first two years of age
without any prior treatment.
2. Study procedures: If you agree to participate in the study, the following procedure will
take place
- Data collection : Once registered you will be required to fill a data collection sheet which
will include demographic information, treatment details and outcomes.
3.Risk from the study: None
4. Benefits from the study: There are direct benefits to you in term of deformity correction
of the foot.
5.Complications: cast loosening, cast-associated skin irritation and neurovascular damage
during tenotomy
6.Compensation: None
7. Confidentiality: Any information related to the study will be kept confidential until and
unless any legal procedure will be needed. In case if the result of the study will be published
the information of the participant would be kept confidential.
8. Rights of the participants: Participant has a right to refuse from being a part of study at
any time without citing any reason.
9. Alternatives to participation in the study: None
 PART 2

Consent

1 I confirm that I have read and understood the information sheet dated ___________for
the above study and have had the opportunity to ask questions.
OR
I have been explained the nature of the study by the Investigator and had the opportunity
to ask questions

2 I understand that my participation in the study is voluntary and that I am free to withdraw
at any time, without giving any reason and without my medical care or legal rights being
affected.

3 I understand that the sponsor of the clinical trial/project, others working on the Sponsor’s
behalf, the Ethics Committee and the regulatory authorities will not need my permission
to look at my health records both in respect of the current study and any further research
that may be conducted in relation to it, even if I withdraw from the trial. However, I
understand that my Identity will not be revealed in any information released to third
parties or published.

4 I agree not to restrict the use of any data or results that arise from this study provided such
a use is only for scientific purpose(s)

5. I agree to take part in the above study.

Signature (or Thumb impression) of the Legally Acceptable Representative: _____________

Signatory’s Name: ______________________________
Date:_________________________________________
Relationship with subject:________________________

Investigator’s statement:-

I, the undersigned have explained to the parent/guardian in a language she/he understands the
procedures to be followed in the study and risks and benefits.

Signature of the Investigator: Date:

Name of the Investigator:

Signature of the Witness: Date:

`

PIRANI SCORING CHART

PATIENT NAME________________________ AGE____ SEX_____ PRIOR

TREATMENT__________________
MOTHER EDUCATIONAL STATUS___________________

PIRANI SCORE KEY: PC – Posterior crease of the ankle, EH – Emptiness of

heel, RE – Rigidity of equinus, MC – Medial crease of foot, LHT – Lateral head
of Talus, CLB- Curvature of the lateral border of the foot, HFCS – hind foot
contracture score, MFCS – Midfoot contracture score, TS – Total score