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The survey of treatment outcome of intraarticular fractures of distal radius (type C) with the locking-volar plate method as an alternative to Percutaneuos pinning (PCP) with Short Forearm plaster

Protocol summary

Study aim
Comparison of the outcomes of treatment of intraarticular fractures of distal radius by the locking-volar plate method with Percutaneuos pinning with Short Forearm plaster
Design
A clinical trial with a parallel group design of 60 patients, enrolled between April 2015 and April 2017, and followed for one year
Settings and conduct
60 patients with a fracture of distal radius that referred to Kerman Bahonar hospital after informed consent were enrolled to study and two methods locking-volar plate and a Percutaneuos pinning with Short Forearm plaster is performed.
Participants/Inclusion and exclusion criteria
Included criteria: Intraarticular fractures of distal radius, age 17-80 years Exclusion criteria: Age below 17 years
Intervention groups
Performance of locking-volar plate method in fractures of distal radius, Performance of Percutaneuos pinning with Short Forearm plaster in fractures of distal radius
Main outcome variables
amount of daily activities؛ domain of joint movement, radiologic finding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150317021497N4
Registration date: 2019-02-11, 1397/11/22
Registration timing: retrospective

Last update: 2019-02-11, 1397/11/22
Update count: 0
Registration date
2019-02-11, 1397/11/22
Registrant information
Name
Mohammadreza Mokhtaree
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34260081
Email address
mrmokhtaree@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of treatment outcome of intraarticular fractures of distal radius (type C) with the locking-volar plate method as an alternative to Percutaneuos pinning (PCP) with Short Forearm plaster
Public title
Study of the effect and comparison of locking-volar plate and Percutaneuos pinning in improving intraarticular fractures of distal radius
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with fractures of distal radius Age 17-80 years
Exclusion criteria:
Distal radial epiphysis opening Ulnar opening Open fracture Fracture in third Ulnar distal Involvement of arterial and nerve together
Age
From 17 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
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
Haft bagh-e alavi, Pardis of Kerman University of medical sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.KMU.REC.1397.168

Health conditions studied

1

Description of health condition studied
Intraarticular fractures of distal radius
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius

Primary outcomes

1

Description
Amount of daily activities
Timepoint
3 months and 12 months after surgery
Method of measurement
Based on self-report questionnaire

2

Description
Domain of movements
Timepoint
3 months and 12 months after surgery
Method of measurement
Observe and measure with goniometer

3

Description
Degenerative changes
Timepoint
3 months and 12 months after surgery
Method of measurement
Radiography

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: the locking-volar plate method
Category
Treatment - Devices

2

Description
Second intervention group: percutaneuos pinning with Short Forearm plaster
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bahonar hospital
Full name of responsible person
Mahdi Ahmadinejad
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Ahmadinejadmahdi@yahoo.com
Web page address
http://www.kmu.ac.ir/fa/bh/page/23113/%D8%B1%DB%8C%D8%A7%D8%B3%D8%AA-%D8%A8%DB%8C%D9%85%D8%A7%D8%B1%D8%B3%D8%AA%D8%A7%D9%86

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Ebn-e sina ST, Vice-chancellor for research, Medical Sciences University
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
vcr@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt/page/23215/%D9%85%D8%B9%D8%A7%D9%88%D9%86-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Mohsen Absalan
Position
Orthopedic surgery residency
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar hospital, Gharani ST
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mohsenabsalan56@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohsen Absalan
Position
Orthopedic surgery residency
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar hospital, Gharani ST
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mohsenabsalan56@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohsen Absalan
Position
Orthopedic surgery residency
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar hospital, Gharani ST
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mohsenabsalan56@gmail.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 of data is shared after coding.
When the data will become available and for how long
6 months after results publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
The data will be sent to further research for better treatment.
From where data/document is obtainable
Sending of formal request to Mohsen Absalan
What processes are involved for a request to access data/document
Get a license from the supervisor
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