The aim of the current study is to compare outcomes of angular deformity correction procedures through three epiphysiodesis techniques including using staple, screw, screw and plaque in modifying angular deformities.
Design
Randomized clinical trial with three intervention parallel groups with outcome assessment
Settings and conduct
Background: Angular deformity treatment
How: simple sampling
Where: Clinics of Al-zahra and Kashani
Method: Epiphysiodesis surgery with staple, screw and screw and plaque techniques
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Presence of non-physiological genu varum or valgum
Presence of angular deformity diagnosed by an orthopedist
Intermalleular diameter(IMD) of over 10 centimeters and intercondylar diameter (ICD) of over 6 centimeters
Unmet criteria:
Parents' dissatisfaction for study participation
Intervention groups
ٍPatients with chief complaint of angular deformity underwent one of the following surgical procedures:
Staple group:Following provisional pin embedding and detection of physis proximal and distal part, staple will be placed in the position of pins.
Screw group:Following embedding provisional pins using C-arm, the physis position will be detected and epiphysiodesis will be performed using canulated screws.
Screw and plaque group:Following provisional pin embedding, distal and proximal part of involved limb will be detected using C-arm and then the plaque will be embedded around the physis bilaterally and screws will be embedded in provisional pins situation bilaterally.
Main outcome variables
Average deviation of mechanical deformity prior to and after surgery,
Deformity correction velocity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170912036152N3
Registration date:2018-12-12, 1397/09/21
Registration timing:retrospective
Last update:2018-12-12, 1397/09/21
Update count:0
Registration date
2018-12-12, 1397/09/21
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3420 1143
Email address
iman.m.sharifi@gmail.com
Recruitment status
Recruitment complete
Funding source
isfahan university of medical sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
2015-01-01, 1393/10/11
Actual recruitment end date
2017-03-21, 1396/01/01
Trial completion date
2017-03-21, 1396/01/01
Scientific title
The effects of epiphysiodesis on angular deformity using staple, screw or plate and screw in children
Public title
pain management in total knee arthroplasty (TKA)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of non-physiological genovugum or genovalogom with its numerical value
Having a kind of angular deformity detected by an orthopedic specialist.
Intermediate distance (IMD) above 10 cm, or Intercondillier spacing (ICD) greater than 6 centimeters
Parental consent to participate in this study
If the mechanical axis of the lower limb is not placed on the knee (outside or inside the knee)
Exclusion criteria:
Uncontrolled metabolic disease
There is less than 12 months to stop the growth of the bone
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
All patients were provided self-specific number using random allocation software and then were divided in three groups based on their numbers of 3k, 3k+1 and 3k+2
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Medical School Ethic Committee
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8196736573
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.MUI.REC.1396.3.832
Health conditions studied
1
Description of health condition studied
Angular deformity
ICD-10 code
Q74.1
ICD-10 code description
Congenital malformation of knee
Primary outcomes
1
Description
Average deviation of mechanical deformity
Timepoint
Prior to the surgery, immediately after surgery and then every three months until a year
Method of measurement
Using Anterior-Posterior radiography
Secondary outcomes
1
Description
Deformity correction velocity
Timepoint
Every three months until a year
Method of measurement
Measurement and comparison of deformity angle using anterior-posterior radiography
Intervention groups
1
Description
Intervention group: Staple group: After patients' positioning in supine position, following provisional pin embedding and detection of physis proximal and distal part, the skin would be incised and staple will be placed in the position of pins(Osveh; Iran).
Category
Treatment - Surgery
2
Description
Intervention group: Screw group: After patients' positioning in supine position, following embedding provisional pins using C-arm, the physis position will be detected and epiphysiodesis will be performed using canulated screws(Osveh; Iran).
Category
Treatment - Surgery
3
Description
Intervention group: Screw and plaque group:After patients' positioning in supine position, following provisional pin embedding, distal and proximal part of involved limb will be detected using C-arm and then the skin will be incised and plaque will be embedded around the physis bilaterally and screws will be embedded in provisional pins situation bilaterally(Osveh; Iran).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Dr Mohammad Ali Tahririan
Street address
Kashani Hospital, Kashani Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8196736573
Phone
+98 31 3972 2306
Email
iman.m.sharifi@gmail.com
2
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Dr Mohammad Ali Tahririan
Street address
Shohadaye Sofeh Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8196736573
Phone
+98 31 3972 2306
Email
iman.m.sharifi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Hezajarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
siavash@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Ghasem Mohammadsharifi
Position
Orthopaedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Kashani Hospital, Kashani Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8196736573
Phone
+98 31342201143
Fax
Email
iman.m.sharifi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sceinces
Full name of responsible person
Dr Mohammad Ali Tahririan
Position
Associate Pprofessor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Hospital, Kashani Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81967367573
Phone
+98 31 3620 2085
Fax
Email
tahririan@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Tahririan
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Hospital, Kashani Strret, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8196736573
Phone
+98 31 3620 2085
Fax
Email
tahririan@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data are type of surgical procedure, deformity correction rate and required duration for deformity correction
When the data will become available and for how long
Since project cessation and its submission, the end of 2019
To whom data/document is available
Researchers who want to compare their projects about angular deformity correction with our findings
Under which criteria data/document could be used
For comparison of different surgical procedures with findings of our study
From where data/document is obtainable
Corresponding of this stud, Dr. Sharifi and Dr. Tahririan should be referred.
What processes are involved for a request to access data/document
The correspondent professor, Dr. Tahririan should be contacted. Then he can provide an SPSS file. This request should be done thorough an Email and proposal and/or an official request from the university.