Comparison of titanium elastic nail, external fixator and casting on prevention of complications in closed diaphyseal tibial fracture in children between 5-12 years old
The aim of this study was to compare titanium elastic nail (TEN) and external fixator (EF) and plastering in diaphyseal closed tibia fracture in children aged 5 to 12 years
Design
The study was a clinical trial using a non-probability sampling method on 120 children 5 to 12 years old with diaphysis closed fracture treated with one of the external fixator and titanium elastic nail and casting techniques.
Settings and conduct
This clinical trial study was conducted in children aged 5 to 12 years old with Tibia diaphyseal closed fractures referred to Shahid Bahonar Hospital in 2016 and 2017.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Children 5 to12 years old with transverse , oblique and long closed tibia fracture
Non-inclusion: Pathological fractures; congenital deformities of the skeletal system ; metabolic diseases
Intervention groups
Intervention group1: Patients treated with titanium elastic nail
Intervention group2:Patients treated with external fixator
Intervention group3:Patients treated with casting
Main outcome variables
Infection, nonfusion, refracture, angulation and more than 1 cm limb difference, as well as patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190127042514N4
Registration date:2020-02-28, 1398/12/09
Registration timing:retrospective
Last update:2020-02-28, 1398/12/09
Update count:0
Registration date
2020-02-28, 1398/12/09
Registrant information
Name
Halimeh Kameshki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 8065
Email address
halimeh.kameshki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-11, 1396/06/20
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2017-09-11, 1396/06/20
Actual recruitment end date
2018-10-02, 1397/07/10
Trial completion date
2018-10-02, 1397/07/10
Scientific title
Comparison of titanium elastic nail, external fixator and casting on prevention of complications in closed diaphyseal tibial fracture in children between 5-12 years old
Public title
Comparison of titanium elastic nail, external fixator and casting on prevention of complications in closed diaphyseal tibial fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 5-12 years old
Closed diaphyseal fracture of the tibia
Exclusion criteria:
Open fracture
Pathological fracture
Metabolic disease
Congenital deformities of the skeletal system
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Kerman University of Medical Sciences
Street address
Ibn Sina avenue; Jahad Blvd
City
Kerman
Province
Kerman
Postal code
76198131592
Approval date
2017-12-17, 1396/09/26
Ethics committee reference number
IR.KMU.REC.1396.1878
Health conditions studied
1
Description of health condition studied
Diaphyseal closed tibia fracture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient satisfaction
Timepoint
2, 6 and 12 months later
Method of measurement
Using the Medical Outcomes Study Short Form 12 (SF-12) and Oxford Score questionnaire according to surgical outcome criteria
2
Description
Non fusion
Timepoint
2, 6 and 12 months later
Method of measurement
Imaging evaluation
3
Description
Refracture
Timepoint
2, 6 and 12 months later
Method of measurement
Imaging evaluation
4
Description
Angulation
Timepoint
2, 6 and 12 months later
Method of measurement
Imaging evaluation
5
Description
Infection
Timepoint
2, 6 and 12 months later
Method of measurement
Physical examination
6
Description
Bone length difference (up to 1 cm)
Timepoint
2, 6 and 12 months later
Method of measurement
Imaging evaluation and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients treated with titanium elastic nail : After choosing the appropriate anesthesia method, the patient was placed supine. The surgical technique began with a closed reduction on the axial axis. Then, under sterile conditions, two surgical incisions in length 20 mm from 10 to 30 mm from the proximal tibial growth plate were made under the fluoroscopic guide on both the inner and outer sides of the lower limb skin. To select the proper Nail diameter after estimating the narrowest part of the central bone channel by imaging the Flynn's equation was used:nail diameter = 0.4 × the diameter of the medullary canal After selecting the appropriate Nail, drill the posterior middle part of proximal metaphysis near the posterior-inner edge of the tibia within 10 cm of the growth plate, then nail medial was inserted by T-handle and the nail end was inserted to the metaphysis. Then, 2 cm away from the nail. After Nail Medial placement, lateral Nail was inserted in the same way
Category
Treatment - Devices
2
Description
Intervention group 2: Patients treated with external fixator: In sterile conditions and under the guide fluorescence, the place of pin was identified and the incision was made. Then the bone and pin were inserted with the appropriate drill and a monolateral external fixator with two rods and four pins was inserted.
Category
Treatment - Devices
3
Description
Intervention group 3: Patients treated with casting:The patient was plastered with a long leg plaster at a knee angle of 20 to 40 degrees to prevent embolism and rest of the Gastrocnemius muscle as well as to provide rotational stability, prior to casting if there was significant displacement, under anesthesia in the emergency or operating room. reduction was done
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahounar hospital
Full name of responsible person
Dr Shahab Ilka
Street address
Qarani avenue
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
amirreza.mirzaei@live.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Shahab Ilka
Street address
Haft Baghe Alavi
City
Kerman
Province
Kerman
Postal code
1355576169
Phone
+98 34 3325 7660
Email
amirreza.mirzaei@live.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Amirreza Mirzaei Sosafidi
Position
Residency of orthopedic
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Qarani Ave
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
amirreza.mirzaei@live.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amirreza Mirzaei Sosafidi
Position
Residency of orthopedic
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Qarani Ave
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
amirreza.mirzaei@live.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amirreza Mirzaei Sosafidi
Position
Residency of orthopedic
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Qarani Ave
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
amirreza.mirzaei@live.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