Comparison the ankle surgery results with tightrope implant and syndesmosis three-cortical screw in patients with ankle syndesmosis injury referring to Alzahra and Kashani hospitals in 2015-17
Comparison of syndesmosis injuries surgical outcomes using tight rope versus tricortical screw
Design
Clinical trial, with control group, with parallel group, double blinded, randomized
Settings and conduct
The study was conducted in Alzahra and Kashani hospitals of Isfahan.
Patients were divided in two groups of tricortical screw and tightrope approach through randomization using random allocation software.
Patients and clinical physician were blinded to the type of surgery.
Tricortical screw: within 1.5cm above ankle joint; fibula and tibia were bilaterally pierced and tricortical screw was fixed.
Tightrope group: Tibia and fibula were pierced throughout of the cortex, tightrope fixation was performed from the medial skin to the other side.
Then results were compared within 6, 12 and 18 months following the surgery regarding range of motion and American Foot and Neck Orthopedic Society.
Participants/Inclusion and exclusion criteria
Patients with syndesmosis injury who were over 18 years were included.
Patients with concurrent talus and calcaneus fracture, previous history of ankle surgery and who had diabetes mellitus and/or rheumatoid arthritis unmet inclusion criteria.
Intervention groups
Tricortical screw: within 1.5cm above ankle joint, fibula and tibia were bilaterally pierced and tricortical screw was fixed.
Tightrope group: Tibia and fibula cortex were totally pierced, medial skin was pierced and tightrope was fixed to the other side.
Main outcome variables
Pain; Plantar flexion; Dorsal flexion; Sagital motion; gate; Hind foot motion; Function; Movement limitation; maximum walk; maximum surface
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190219042756N1
Registration date:2019-03-29, 1398/01/09
Registration timing:retrospective
Last update:2019-03-29, 1398/01/09
Update count:0
Registration date
2019-03-29, 1398/01/09
Registrant information
Name
Sina Talebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3444 7707
Email address
sinatalebi_3969@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
2015-10-23, 1394/08/01
Actual recruitment end date
2018-04-26, 1397/02/06
Trial completion date
2018-04-26, 1397/02/06
Scientific title
Comparison the ankle surgery results with tightrope implant and syndesmosis three-cortical screw in patients with ankle syndesmosis injury referring to Alzahra and Kashani hospitals in 2015-17
Public title
Comparison the ankle surgery results with tightrope implant and syndesmosis three-cortical screw in patients with ankle syndesmosis injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of above 18 years old
Ankle syndesmosis injury
Exclusion criteria:
Concurrent talus and calcaneus fracture
Previous history of ankle and peri-ankle tissue fracture
Diabetes Mellitus
Arthritis Rheumatoid
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were provided with numbers using Random Allocation software and considering whether even or odd number they were allocated to tightrope fixation or tightrope fixation approach respectively
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were blinded to type of surgery and the person who assessed outcomes was blinded to type of surgery
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
ir.mui.rec.1396.4.420
Health conditions studied
1
Description of health condition studied
Ankle syndesmosis injury
ICD-10 code
S90.91
ICD-10 code description
Unspecified superficial injury of ankle
Primary outcomes
1
Description
American Orthopaedic Foot & Ankle Society Score
Timepoint
6, 12 and 18 months after surgical procedure
Method of measurement
Based on scoring system of American Orthopaedic Foot & Ankle Society
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Tricortical screw: in this technique within 1.5 centimeters further than ankle, fibula and tibia cortex will be pierced and tricortical screw was fixed.
Category
Treatment - Surgery
2
Description
Intervention group: tightrope group: in this technique fibula and tibia cortex will be pierced and tightrope will be moved from medial holes to lateral ones and then flipped.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sina Talebi
Street address
Shohaday-e-Sofe
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sinatalebi_3969@yahoo.com
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Sina Talebi
Street address
Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sinatalebi_3969@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
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
Esfahan University of Medical Sciences
Full name of responsible person
Sina Talebi
Position
Orthopedist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 314447707
Email
sinatalebi_3969@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sina Talebi
Position
Orthopedist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 314447707
Email
sinatalebi_3969@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sina Talebi
Position
Orthopedist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 314447707
Email
sinatalebi_3969@yahoo.com
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
Yes - There is 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 has been published as an article
When the data will become available and for how long
Following article publication as it has been accepted now
To whom data/document is available
Orthopedics projects with similar titles
Under which criteria data/document could be used
For University projects and in case of being in touch with corresponding author of the study
From where data/document is obtainable
Making touch with corresponding author of the study Dr. Sina Talebi
What processes are involved for a request to access data/document
Keeping touch with the corresponding author and coordination with University