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Comparison of manual reduction vs. new tractional technique in distal radius fractures

Protocol summary

Study aim
Comparison of manual reduction method and modern stretching method in the success rate of distal radius fracture reduction and its outcome
Design
In this clinical trial (without blindness), 30 patients with distal radius fractures , using the Excel Rand function will be randomly assigned to two parallel groups of 15 people . The first group will be performed by traditional method, reduction by hand and the second group by new method under fluoroscopic instruments.
Settings and conduct
This study will be performed on patients with distal radius fractures referred to the orthopedic clinic of Besat hospital in Hamadan . In order to repair the fracture, two traditional methods and the new method will be used. In both groups, after fracture reduction, casting is performed and then patients, one week and five weeks after treatment, will refereed to clinic for care and evaluation of treatment outcome.
Participants/Inclusion and exclusion criteria
Participants included patients over 16 years of age with distal radius fractures who consented to participate in the study. Patients with joint involvement, open fractures and soft tissue damage will not be eligible for the study.
Intervention groups
The first group of distal radius fractures, in the traditional way, will be subjected to manual reduction. In this method, the physician's assistant pulls the wrist with great force and then bends it at an angle of 15 degrees. The surgeon simultaneously repair the fracture. In the new method, using the patient's elbows and fingers, it is hung from the bed and attached to the weight. Then, under fluoroscopy, the surgeon places the injured part in the proper direction.
Main outcome variables
The main consequence of improving the distal radius fracture, improving hand function, reducing pain at the fracture site

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N21
Registration date: 2022-04-18, 1401/01/29
Registration timing: prospective

Last update: 2022-04-18, 1401/01/29
Update count: 0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of manual reduction vs. new tractional technique in distal radius fractures
Public title
Reduction of the distal radius fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Radial radius fracture Age over 16 years Posterior rotation less than 15 degrees and radius shortening less than 5 mm
Exclusion criteria:
Joint involvement Open fractures and soft tissue damage Severe bone damage
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
30 samples with computer software will be randomly coded in two groups I and C and the codes will be entered on the raw checklists. Upon referral of a qualified patient, one of the checklists will be randomly selected. If the selected code is I, the Fracture reduction will be with instrument and if it is C, it manual Fracture reduction will be done.
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 Hamadan University of Medical Science
Street address
ُShahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.UMSHA.REC.1401.032

Health conditions studied

1

Description of health condition studied
Distal radius fracture
ICD-10 code
M84.33
ICD-10 code description
Stress fracture, ulna and radius

Primary outcomes

1

Description
Radius fracture reduction
Timepoint
First and five week after treatment
Method of measurement
Radiography

2

Description
Radial size
Timepoint
First and five week after treatment
Method of measurement
Radiography

3

Description
Radial deformation
Timepoint
First and five week after treatment
Method of measurement
Radiography

Secondary outcomes

1

Description
Postoperative patients' pain score
Timepoint
Fifth week of treatment
Method of measurement
Visual Analogue Scale (VAS)

Intervention groups

1

Description
Intervention group: In this group, the traditional method based on pressure and traction by surgeons hand Fracture reduction will be performed
Category
Treatment - Surgery

2

Description
Control group: In this group, using a new method, mechanical tools will be used to create pressure and traction fracture reduction.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Erfan Rohani
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
erfanrohani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.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
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Erfan Rohani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Besat Hospital, Shahid Beheshti Blv, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
erfanrohani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medicine school shahid fahmideh Ave, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.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
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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