The aim of this study is to evaluate the radiologic changes of treatment of unstable distal radius fractures using three cross pin compared with 4 pins trans radioulnar. The sample size will be 50 patients. In a randomized clinical trial, 50 patients with age of 18-65 years old with distal radius fracture will be assigned into two surgical methods of three cross pin or 4 pins trans radioulnar. All the patients will be examined and taken radiography immediately after the operation and 6, 12 and 24 weeks after the operation. Then the outcome measures including the pain severity, radiography measures and wrist range of motion will be compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112727797N1
Registration date:2016-11-27, 1395/09/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Masoud Bahrami Ferydoni
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.bahrami@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of radiologic changes of unstable fractures of the distal radius bone using of three cross pin with 4 pin trans-radioulnar
Public title
Comparison of radiologic changes of unstable fractures of the distal radius bone between the two surgical methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 years; patients with closed fractures and intra-articular distal radius that needed to be fixed surgery; also informed consent of patient in the study.
Exclusion criteria: surgery on wrist; severe underlying disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, 50 patients have been assigned to two groups of intervention and control by using random numbers table
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol-Mazandaran- Iran
City
Babol
Postal code
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
305808/ژ/پ
Health conditions studied
1
Description of health condition studied
Distal radius fracture
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
Range of motion of wrist
Timepoint
Immediately after surgery, then the sixth and the twelve and the twenty-fourth weeks after surgery
Method of measurement
Through the examination with handheld goniometer
2
Description
Determination radiographic parameters
Timepoint
Immediately after surgery, then the sixth and the twelve and the twenty-fourth weeks after surgery
Method of measurement
Measurement reference markers in the radiographic image
Secondary outcomes
1
Description
Pain severity
Timepoint
Twenty-fourth weeks after surgery
Method of measurement
By Visual Analogus Scale questionnaire
2
Description
Pin tract infection
Timepoint
Six weeks after surgery
Method of measurement
Observation
Intervention groups
1
Description
For patients cross-pin ulnar corner fixator: Pin-third of the ulnar angle into the distal radius.
Category
Treatment - Surgery
2
Description
In patients Trans-ulnoradial pinning: Pin-third the size of 1.5 in the distal is obliquely driven to the fracture site and the fourth pin of size 2 in proximal of to the fracture site is driven cross-ulnar into the radius bone and it will be ended in the cortex of the radius bone.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
Street address
Babol University of Medical sciences- Ganjafrooz street- Babol- Iran
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Reaserch and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr.Aliakbar Moghaddamnia
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Reaserch and Technology, Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Danyal Hosseinzadeh
Position
Resident of Orthopedic
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 119832197667
Fax
Email
danyal_h1984@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahrami Frydoni
Position
Assistant Professer of Orthopedic
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 119832197667
Fax
Email
Dr bahrami865@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Danyal Hosseinzade
Position
Resident of Orthopedic
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
danyal_h1984@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)