Choosing the right treatment method for fractures distal radius
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
In this clinical trial, all patients who undergo surgery in Hospitals , Babol University of Medical Sciences with a diagnosis of Radial Distal Fractures underwent one of three methods of external fixation, external fixator, Kei wire, are included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 65-95 years Patients with closed fractures and intra-articular distal radius that needed to be fixed surgery Informed consent of patient in the study. Exclusion criteria: Non-traumatic pathologic fractures caused by tumors, severe underlying disease at the same time ipsilateral upper extremity fractures Patient dissatisfaction Sudeck's atrophy and Women over 50 years who have osteoporosis radiography.
Intervention groups
Group 1 by external fixation, Group 2 by external fixator with pinning and Group 3 treated was with Kei wire.
Main outcome variables
Rate of union; Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190221042782N1
Registration date:2019-04-18, 1398/01/29
Registration timing:registered_while_recruiting
Last update:2019-04-18, 1398/01/29
Update count:0
Registration date
2019-04-18, 1398/01/29
Registrant information
Name
Seyyed Mokhtar Esmaeilnejadganji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.esmaeilnejadganji@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison outcome of volar plate, external fixator and multi pining for intra articular distal radius fracture treatments
Public title
Comparison outcome of fractures of the distal radius bone between the two surgical methods of unstable fractures of the distal radius bone between the two surgical methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years
Intra-articular distal radius fractures caused by trauma
Exclusion criteria:
Non-traumatic pathologic fractures caused by tumors
Severe underlying disease
At the same time ipsilateral upper extremity fractures
Patient dissatisfaction
Sudeck's atrophy
Women over 50 years who have osteoporosis radiography
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
These patients using random selection based on the application online http://www.graphpad.com/quickcalcs/randomize1/ will be divided into three groups.The use of external fixation technique for Group 1, with external fixator pins for Group 2 and Group 3 will be considered for long wire.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will not be aware of the treatment they are taking, and this will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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
Province
Mazandaran
Postal code
4716681451
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.246
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,Ten days after surgery, then the sixth and the Twenty-one and the forty- second weeks after surgery
Method of measurement
Through the examination with handheld goniometer
2
Description
Determination Radio graphic parameters
Timepoint
Immediately after surgery,Ten days after surgery, then the sixth and the Twenty-one and the forty- second weeks after surgery
Method of measurement
Measurement reference markers in the radiographic image
Secondary outcomes
1
Description
Pain severity
Timepoint
Twenty-one, forty-second weeks after surgery
Method of measurement
By Visual Analogous Scale questionnaire
2
Description
Pin tract infection
Timepoint
Twenty-one, forty-second weeks after surgery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: In patients with external fixation using two pins 5/2 mm Schanz pins in the second metacarpal and two 5.3 mm in radius, proximal to the fracture. These pins are connected to each other and the firm. After creating this reduction in the frame and lateral C-arm and Anteroposterior will be controlled.
Category
Treatment - Surgery
2
Description
Intervention group: In patients with external fixator with pinning depending on the patient's need, 2 or 3 pins will also be used for fixation of the fracture site.
Category
Treatment - Surgery
3
Description
Control group: In patients treated with closed reduction of fracture when the wire just under anesthesia and fixation with pins (depending on the shape of fracture 3 or 4 pins) control and reduction and fixation with AP and lateral radiography C_arm during surgery and after surgery is controlled.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Seyyed Mokhtar Esmaeilnejadganji
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
smsnganji@yahoo.com
Web page address
http://www.mubabol.ac.ir
2
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital, Babol
Full name of responsible person
Seyyed Mokhtar Esmaeilnejadganji
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3223 8301
Email
smsnganji@yahoo.com
Web page address
http://www.mubabol.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Yahyanejad Hospital in Babol
Full name of responsible person
Seyyed Mokhtar Esmaeilnejadganji
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 3594
Email
smsnganji@yahoo.com
Web page address
http://www.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4718523596
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Seyyed Mokhtar Esmaeilnejadganji
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
smsnganji@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyyed Mokhtar Esmaeilnejadganji
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
smsnganji@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Farzad Ghezelsofla
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
f_ghezelsofla_md@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD