CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/01/079396 [Registered on: 24/01/2025] Trial Registered Prospectively

Last Modified On:

18/01/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Other (Specify) [Plater Immoblization ]

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of traditional plaster cast and light weight plaster splint for treatment of idiopathic clubfoot in infants - A randomized control trial

Scientific Title of Study

Comparison of traditional above-knee Plaster-of-Paris casts and Plaster-of-Paris posterior slabs for immobilization of the foot and ankle during Ponseti casting for idiopathic clubfoot in infants - A randomized control trial

Trial Acronym

NIl

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Hitesh Shah
Designation	Professor
Affiliation	Kasturba Medical College, Manipal
Address	Room No 6, Kasturba Hospital, Department of Paediatric Orthopaedics, Madhav Nagar, Manipal, Kasturba Medical College, Manipal Udupi KARNATAKA 576012 India
Phone	08202923918
Fax
Email	hitesh.shah@manipal.edu

Details of Contact Person
Scientific Query

Name	Hitesh Shah
Designation	Professor
Affiliation	Kasturba Medical College, Manipal
Address	Room No 6, Kasturba Hospital, Department of Paediatric Orthopaedics, Madhav Nagar, Manipal, Kasturba Medical College, Manipal KARNATAKA 576012 India
Phone	08202923918
Fax
Email	hitesh.shah@manipal.edu

Details of Contact Person
Public Query

Name	Hitesh Shah
Designation	Professor
Affiliation	Kasturba Medical College, Manipal
Address	Room No 6, Kasturba Hospital, Department of Paediatric Orthopaedics, Madhav Nagar, Manipal, Kasturba Medical College, Manipal KARNATAKA 576012 India
Phone	08202923918
Fax
Email	hitesh.shah@manipal.edu

Source of Monetary or Material Support

Dr. Hitesh Shah Department of Paediatric orthopaedics, Room number 5, KMC, Madhav nagar, Manipal , karnataka India 576102

Primary Sponsor

Name	Dr Hitesh Shah
Address	Room 6, Kasturba Hospital, Department of Paediatric Orthopaedics, KMC, Manipal 576102
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 Hitesh Shah	Kasturba Hospital Manipal	Room No 6, Kasturba Hospital, Department of Paediatric Orthopaedics, Madhav Nagar, Manipal, Kasturba Medical College, Manipal Udupi KARNATAKA	08202923918 hitesh.shah@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and kasturba Hospital Institutional Ethics Committee	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
Comparator Agent	Traditional plaster cast and traditional plaster cast	Intervention of serial manipulation and immoblization with plaster cast in intervention group Each visit patient will be treated with same methods. Total duration of the plaster cast for one week. Plaster cast is changed every weekly. Cast will be applied for total 6 weeks.
Intervention	Traditional plaster cast and plaster slab	Intervention of serial manipulation and immoblization with plaster slab in intervention group Each visit patient will be treated with same methods. Total duration of the plaster slab for one week. Plaster slab is changed every weekly. Slab will be applied for total 6 weeks.

Inclusion Criteria

Age From	0.00 Year(s)
Age To	0.30 Year(s)
Gender	Both
Details	Infant less than 3 months Unilateral idiopathic clubfeet Left foot of bilateral clubfeet

ExclusionCriteria

Details

Clubfoot associated with arthrogryposis, spina bifida, limb deficiencies, congenital constriction band syndrome, skeletal dysplasia and syndromes

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

On-site computer system

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
The number of casts / slabs required to obtain complete correction of the deformity (Pirani Score 0)	1 months, 2 months, 6 months

Secondary Outcome

Outcome	TimePoints
The frequency of cast or slab-related problems i. Slippage of casts / slabs ii. Breakage of casts / slabs iii. Skin problems such as plaster rash	weekly, 3 months, 6 months

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
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

Phase 2

Date of First Enrollment (India)

01/09/2025

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="6"
Days="1"

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

Traditionally, plaster-of-Paris has been used as the casting material for immobilising the foot and ankle to maintain correction during Ponseti treatment of idiopathic clubfoot. (1, 2) More recently, synthetic casting material has been tried in a few centres.(5-7) Removal of the plaster-of-Paris cast involves splitting the cast with a plaster saw or soaking the cast and cutting it with scissors. The use of the noisy saw can be stressful for the baby and particles of plaster-of-Paris tend to be dispersed by the saw. Injury to the skin is also a well-recognized potential complication of the use of the plaster saw. Synthetic Soft cast, on the other hand, can be removed by unwinding the rolled cast material.

The efficacy of synthetic casts in maintaining correction of the deformity has been studied and found to be comparable to Plaster-of-Paris (5, 8) even though the mechanical properties of synthetic semi-rigid Soft cast are inferior to Plaster-of-Paris. (9) Parents preferred semi-rigid synthetic casts to Plaster-of-Paris casts. (10)

Woodcast slabs have also been used effectively in the treatment of infantile clubfoot (11). One retrospective study without a control group reported the use of a plaster slab used for immobilizing the foot and ankle during non-operative treatment of clubfoot (12).

To the best of our knowledge, no randomized control trial has been done to compare the efficacy Plaster-of-Paris casts versus Plaster-of-Paris slabs for immobilizing the foot during the treatment of infantile club foot.

References:

1. Ponseti IV. The ponseti technique for correction of congenital clubfoot. The Journal of bone and joint surgery American volume. 2002;84-A(10):1889-90; author reply 90-1.

2. Bor N, Herzenberg JE, Frick SL. Ponseti management of clubfoot in older infants. Clinical orthopaedics and related research. 2006;444:224-8.

3. Banskota B, Banskota AK, Regmi R, Rajbhandary T, Shrestha OP, Spiegel DA. The Ponseti method in the treatment of children with idiopathic clubfoot presenting between five and ten years of age. The bone & joint journal. 2013;95-B(12):1721-5.

4. Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. Journal of pediatric orthopedics. 2002;22(4):517-21.

5. Aydin BK, Sofu H, Senaran H, Erkocak OF, Acar MA, Kirac Y. Treatment of Clubfoot With Ponseti Method Using Semirigid Synthetic Softcast. Medicine. 2015;94(47):e2072.

6. Stephan C, Herzenberg JE, Araujo FF. Accurate determination of cast weight for neonates with clubfoot. Journal of pediatric orthopedics. 2000;20(2):230-3.

7. Hui C, Joughin E, Nettel-Aguirre A, Goldstein S, Harder J, Kiefer G, et al. Comparison of cast materials for the treatment of congenital idiopathic clubfoot using the Ponseti method: a prospective randomized controlled trial. Canadian journal of surgery Journal canadien de chirurgie. 2014;57(4):247-53.

8. Brewster MB, Gupta M, Pattison GT, Dunn-van der Ploeg ID. Ponseti casting: a new soft option. The Journal of bone and joint surgery British volume. 2008;90(11):1512-5.

9. Zmurko MG, Belkoff SM, Herzenberg JE. Mechanical evaluation of a soft cast material. Orthopedics. 1997;20(8):693-8.

10. Coss HS, Hennrikus WL. Parent satisfaction comparing two bandage materials used during serial casting in infants. Foot & ankle international. 1996;17(8):483-6.

11. Singh KA, Shah H, Joseph B. Comparison of plaster-of-Paris casts and Woodcast splints for immobilization of the limb during serial manipulation and casting for idiopathic clubfoot in infants. Bone Joint J. 2020 Oct;102-B (10):1399-1404. doi: 10.1302/0301-620X.102B10.BJJ-2020-0181.R4. PMID: 32993325.

12. Gigante C, Pedrotti L, Guido D. Proposal of an innovative casting technique for correction of clubfoot according to Ponseti method: a pilot study. J Pediatr Orthop B. 2019 May;28(3):242-247. doi: 10.1097/BPB.0000000000000539. PMID: 30252794.