Comparison the therapeutic results of conventional and accelerated Ponseti method in children with idiopathic clubfoot
Design
Randomized, parallel group trial with blinded outcome assessment. Randomization was centralized with simple randomization with random number tables
Settings and conduct
Sixty patients with idiopathic clubfoot are randomly divided and evaluated into two intervention groups including conventional and accelerated ponseti method. In the conventional ponseti group, plasters are replaced weekly and on a fixed day and in the accelerated ponseti group, plasters are replaced two times in a week and on fixed days. Data analyses are blind to the groups allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria are children with idiopathic clubfoot and aged less than1 year; The exclusion criteria are children with the syndromic and complex club foot, the relapsed club foot and history of any surgical or non-surgical procedure in other centers.
Intervention groups
Sixty patients are randomly divided into two intervention groups (n=30 cases). In the intervention group 1, the treatment will be performed by conventional ponseti method and in the intervention group 2, the treatment will be performed by accelerated ponseti method.
Main outcome variables
Required times for plastering in order to abduction the foot to 70° in relation to the leg and skin complications such as severe erythema, ulcer, skin necrosis and severe maceration are evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180924041120N1
Registration date:2018-10-06, 1397/07/14
Registration timing:registered_while_recruiting
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Hamed Bahrami Yarahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8383
Email address
yarahmadibahrami.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Therapeutic Results of Conventional and Accelerated Ponseti Method in Children with Idiopathic Clubfoot
Public title
Comparison the Therapeutic Results of Conventional and Accelerated Ponseti Method in Children with Idiopathic Clubfoot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Idiopathic Clubfoot
Age <1 year
Exclusion criteria:
The syndromic and complex club foot
The relapsed club foot
History of any surgical or non-surgical procedure in other centers
Age
To 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Two feet in a child
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random allocation rule: First the sample size was calculated. Then, the subjects (n=60) are randomly assigned into two groups of conventional and accelerated Ponseti method (each 30). In the random assignment, 28 cards are assigned to intervention and 28 to control group. The cards are randomly and without replacement removed from the box and the sequence is recorded.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyses are blind to the groups allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Blvd., Research deputy, Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-11-08, 1396/08/17
Ethics committee reference number
IR.AJUMS.REC.1396.1052
Health conditions studied
1
Description of health condition studied
club foot
ICD-10 code
Q66.8
ICD-10 code description
Other congenital deformities of feet
Primary outcomes
1
Description
Rate of deformity correction
Timepoint
When the foot could be abducted to 70° in relation to the leg
Method of measurement
According to the Dimeglio and Pirani scoring systems
2
Description
Duration of treatment
Timepoint
The interval between the beginning and the completion of plastering
Method of measurement
Number of weeks
3
Description
Skin complications
Timepoint
The interval between the beginning and the completion of plastering
Method of measurement
Weekly examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The treatment will be performed by conventional ponseti method. The plasters are replaced weekly on a fixed day and continued since the foot could be abducted to 70° in relation to the leg.
Category
Treatment - Other
2
Description
Intervention group 2: The treatment will be performed by accelerated ponseti method. The plasters are replaced two times in a week on fixed days and continued since the foot could be abducted to 70° in relation to the leg.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hamidreza Arti
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3292 1836
Email
hamidrezaarti@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
96172
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamed Bahrami Yarahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Hamedbahrami99@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamid Reza Arti
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3292 1836
Email
hamidrezaarti@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamed Bahrami Yarahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Hamedbahrami99@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available