Comparison of Minimal Invasive and conventional plating method in the treatment of tibial shaft fractures
Design
In this research, 40 patients with Tibia shaft fracture are enrolled according to inclusion and exclusion criteria and then randomly assigned to two intervention and control groups by random number table.
Settings and conduct
In this research, 40 patients with Tibia shaft fracture referring to Shahid Rahnemon Hospital during the period 2017.22.11 to 2022.22.11 are enrolled according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with tibial shaft fracture; age range between 18 and 70 years; duration between fracture to surgery less than a week; just types A and B according to AO classification system; informed consent. Exclusion criteria: Patients with fractures in other organs; open fractures; head injuries lead to admitting the ICU; presence of burns to the same organ.
Intervention groups
Treatment of Tibia shaft fracture in the intervention group is performed by Minimal Invasive surgery and conventional surgery is used in the control group. In both groups, patients undergo postoperative visits and dressing will be performed one week after surgery. Sutures are removed on second week, and every 3 weeks visit is done with X-ray. When 3 of 4 cortices of Tibia get union, back to work without crutches are allowed.
Main outcome variables
union time ؛ knee range of motion ؛ infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161225031559N2
Registration date:2018-01-21, 1396/11/01
Registration timing:registered_while_recruiting
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Seyed Hossein Saeed-Banadaky
Name of organization / entity
Shahid Sadoughi Medical University
Country
Iran (Islamic Republic of)
Phone
+98 35 3626 0001
Email address
saeed@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research Yazd Shahid Sadoughi University of medical sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Minimal Invasive and conventional plating methods in treatment of Tibia shaft fracture
Public title
Comparison of 2 plating technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with tibial shaft fracture
Age range between 18 and 70 years
Duration from fracture to surgery less than a week
Just types A and B fracture according to AO classification system
Informed consent
Exclusion criteria:
Patients with fractures in other organs
Patients with open fractures
head injuries lead to admitting the ICU
Burns to the same organ
delayed operation more than one week
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study through simple random method with the table of random numbers patients assigned to two groups.
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 Yazd Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Sq,Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-10-02, 1396/07/10
Ethics committee reference number
IR.SSU.REC.1396.118
Health conditions studied
1
Description of health condition studied
Tibia shaft fracture
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
Primary outcomes
1
Description
three of four cortex union time according to x-ray
Timepoint
One week after the surgery, 2 weeks after the surgery, and then every 3 weeks
Method of measurement
Physician examination and X-ray results
Secondary outcomes
1
Description
nonunion
Timepoint
From the fifth week after surgery
Method of measurement
X-ray results
2
Description
Infection
Timepoint
One week after surgery, 2 weeks after surgery, and then every 3 weeks
Method of measurement
Physician examination by specialist
3
Description
The need for re-surgery
Timepoint
2 weeks after the surgery and then every 3 weeks
Method of measurement
Physician examination by specialist
Intervention groups
1
Description
Control group: After induction of anesthesia and stabilization of vital signs, the open reduction, and the fixation are completed with the plate. The surgical procedure is such that after anesthesia the patient is placed on a standard radiolucent table. After the preparation of the limb, bone exposes with the longitudinal incision on the anterior aspect of leg in the fracture site and bone fixation is done with 8 hole 4.5 millimeter-plate and its screws.Wound closes in various layers under the drain. Dressing and short-leg splint are applied.
Category
Treatment - Surgery
2
Description
Intervention group: After induction of anesthesia and stabilization of vital signs, the reduction, and the fixation are completed with the plate. The surgical procedure is such that after anesthesia the patient is placed on a standard radiolucent table. After the preparation of the limb, bone exposes with two small longitudinal incisions in the proximal and distal parts of fracture. Then the reduction is done in a closed manner and controlled by fluoroscopy. Using a 3.5-millimeter locking plate and its screws fixation are performed without opening the fracture site. The plate is guided from the upper incisions to the distal, and fix with three screws in the proximal and three screws in distal.Wound closes in various layers under the drain. Dressing and short-leg splint are applied.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Doctor Rahnemoon Hospital
Full name of responsible person
Seyed Hossein Saeed
Street address
Shahid Doctor Rahnemoon Hospital, Farrokhi Street, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3626 0000
Email
saeed@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Sq,Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
ahmehrparvar@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Yazd Shahid Sadoughi 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Position
Vice chancellor for research
Latest degree
Specialist
Other areas of specialty/work
Occupational Medicine
Street address
Yazd Shahid Sadoughi university of medical sciences, Bahonar Sq, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
Email
ahmehrparvar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Seyed Hossein Saeed Banadaki
Position
fellowship in hand and upper extremity surgery
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Department of Orthopedics, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0000
Fax
Email
h.saeed.b@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Seyed Hossein Saeed Banadaki
Position
fellowship in hand and upper extremity surgery
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Doctor Rahnemoon Hospital, Farokhi St., Yazd.
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0000
Fax
Email
h.saeed.b@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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