Outcomes of unstable intera articular distal radius fracture using closed reduction, percutaneous pinning and plaster cast compared with closed reduction and plaster cast in patient older than 65 years
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 a Shahid Beheshti Hospital with a diagnosis of Radial Distal Fractures underwent one of two methods of closure reduction, percutaneous pinning, placement and closure reduction, 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: Surgery on wrist Severe underlying disease Lack of timely referral for follow-up therapy to the orthopedic clinic.
Intervention groups
One group was packed and pining, and another group was treated with closure and plaster reduction.
Main outcome variables
Rate of union; Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160508027797N4
Registration date:2019-03-11, 1397/12/20
Registration timing:registered_while_recruiting
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
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
Expected recruitment start date
2018-12-30, 1397/10/09
Expected recruitment end date
2019-12-30, 1398/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcomes of unstable intera articular distal radius fracture using closed reduction, percutaneous pinning and plaster cast compared with closed reduction and plaster cast in patient older than 65 years
Public title
Comparison outcome of unstable 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 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:
Surgery on wrist
Severe underlying disease
Lack of timely referral for follow-up therapy to the orthopedic clinic
Age
From 65 years old to 95 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly divided into two groups. In this study, toss to generate a random sequence in the trial will be two groups. So that one of the study groups is Milk and the other is the line, and based on the sample size, the same number of coins will be thrown, and the individuals will be randomly assigned to two groups. Group line patients treated with closed reduction and pinning and milk treated with closed reduction and casting will be.
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
2018-12-30, 1397/10/09
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.237
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 three and the sixth 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, then the thre e and the sixth and the forty- second weeks after surgery
Method of measurement
Measurement reference markers in the radiographic image
Secondary outcomes
1
Description
Pain severity
Timepoint
Forty-second weeks after surgery
Method of measurement
By Visual Analogous Scale questionnaire
2
Description
Pin tract infection
Timepoint
Three weeks after surgery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: In patients reduction and casting, closed reduction of fracture with in the first 24 hours and then by stretching and manipulation under general anesthesia for closed reduction of fracture is tried. After the reduction approved by the ray casting is conducted at casting method does not need to roll the fabric.
Category
Treatment - Surgery
2
Description
Control group: In percutaneous pining first closed reduction of fracture under general anesthesia in the first 24 hours was (stretching and manipulation attempts at closed reduction of fracture with the help of rolls of fabric to a height of 20 cm below the wrist placed) then 3 pins 2mm diameter entering a pin in the radial styloid volar radius in the arm and the other arm on the dorsal side and one on the ulnar, radial pin total of 3 proved to be, taken. C-arm fluoroscopy control pin will be approved and then took a long chalk.
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
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Drbahrami865@gmail.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
Dr. Masoud Bahrami Ferydoni
Position
Asistant 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
Drbahrami865@gmail.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
Dr. Masoud Bahrami Ferydoni
Position
Asistant 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
Drbahrami865@gmail.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. Siyavash Gharouy
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
sigharouy@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