Evaluation of the results of treatment of pilon fracture with low profile plate
Design
Clinical trial without control group, phase 3 on 40patients
Settings and conduct
This study is performed in Kashani Hospital in Isfahan. Patients are evaluated at one-month, three-month, and six-month intervals. Examination for superficial wound infections, evidence of osteomyelitis, non-healing and bad welding are evaluated in two axes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pilon fracture based on specialist diagnosis, patient consent to participate in the study, unilateral fracture. Exclusion criteria: open fracture, soft tissue injury, history of previous fracture or deformity in the ankle, history of systemic disease such as diabetes
Intervention groups
Intervention group: Patients with pylon fractures will be treated with low profile plaques according to the inclusion and exclusion criteria. These patients are evaluated at intervals of one month, three months and six months. Examination for superficial wound infections, evidence of osteomyelitis, non-healing and bad welding are evaluated in two axes.
Main outcome variables
Superficial wound infections, evidence of osteomyelitis, non-union and malunion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N8
Registration date:2020-12-23, 1399/10/03
Registration timing:prospective
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the results of treatment of pilon fracture with low profile plate
Public title
Treatment of pilon fracture with low profile plate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pilon fracture based on specialist diagnosis
Patient consent to participate in the study
Unilateral fracture
Exclusion criteria:
Open fracture
Soft tissue damage
History of previous ankle fracture or deformity
History of systemic diseases such as diabetes
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IsfahanUniversity of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-23, 1399/06/02
Ethics committee reference number
IR.MUI.MED.REC.1399.429
Health conditions studied
1
Description of health condition studied
Pilon fracture
ICD-10 code
S82.87
ICD-10 code description
Pilon fracture of tibia
Primary outcomes
1
Description
Superficial wound infections
Timepoint
With an interval of one month, three months and six months after surgery
Method of measurement
Visiting patients
2
Description
Evidence of osteomyelitis
Timepoint
With an interval of one month, three months and six months after surgery
Method of measurement
Visiting patients
3
Description
Non-union and malunion
Timepoint
With an interval of one month, three months and six months after surgery
Method of measurement
Examination and radiograph
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with pylon fractures will be treated with low profile plaques according to the inclusion and exclusion criteria. These patients are evaluated at intervals of one month, three months and six months. Examination for superficial wound infections, evidence of osteomyelitis, non-healing and bad welding are evaluated in two axes.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Ali Andalib
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
Ali_andalib@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Web page address
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
Ali Andalib
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
ali_andelib@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Andalib
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
ali_andelib@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Andalib
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
ali_andelib@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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.