Protocol summary

Study aim
A comparison between standard short arm cast and shortened short arm cast in wrist fractures in upper limb fractures
Design
This research will be done by randomized clinical trial. All of the patients who come to the emergency department of "Tehran 7tir Hospital" with trauma to the hand or wrist that need short arm cast, will be enroll in this study. Patients will be randomly assigned to two groups by a random block method. Each block contains 10 numbers. Because we did not find any record or research about this subject, a pilot study with 30 patients will be initially performed and corresponding indicators will be derived and based on that sample size calculations will be done using Altman’s nomogram.
Settings and conduct
All of the patients who come to the emergency department of "Tehran 7tir Hospital" with trauma to the hand or wrist that need short arm cast without any evidence of dislocation and laceration, will be enroll in this study. Patients will be randomly assigned to two groups. In case group bracing up will be done by using half size cast (from the fingers until middle of the forearm) and in the control group it will be done by using a regular cast (from the fingers until one inch below the elbow). General information and medical prescription and same advice are implemented for both groups. The pain score of all patients are obtained and recorded for later investigations. After data gathering, Patient’s data will be analyzed by person who is blinded to two groups.
Participants/Inclusion and exclusion criteria
All of the patients who admitted in the emergency department of "Tehran 7th Tir Hospital" with trauma to the hand and wrist that need casting, without any evidence of dislocation and laceration, will be enrolled in this study. Patients under eighteen years old and those that cannot be following up will be rolled out.
Intervention groups
In case group bracing up will be done by using half size cast (from the fingers until middle of the forearm) and in the control group it will be done by using a regular cast (from the fingers until one inch below the elbow).
Main outcome variables
Study Indices, including recovery time, duration of pain and swelling, union, nonunion, malunion and pain score in both groups will be compared. These signs and symptoms will be reassessed and recorded during one week, two weeks, four weeks and eight weeks from casting to removal time.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170105031787N3
Registration date: 2018-03-01, 1396/12/10
Registration timing: prospective

Last update: 2018-03-01, 1396/12/10
Update count: 0
Registration date
2018-03-01, 1396/12/10
Registrant information
Name
Mohammad-Reza Yasinzadeh
Name of organization / entity
Iran university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
yasinzadeh.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between standard short arm cast and shortened short arm cast in wrist fractures in upper limb fractures
Public title
Using of short arm cast for immobilization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients, who admitted in the emergency department of “7tir Hospital” in Tehran with a complaint of upper limb trauma and need casting. Patients over the eighteen years old and under the one hundred and forty years old are enrolled.
Exclusion criteria:
Exclusion criteria: Patients under eighteen years old and those that can not be follow up will be rolled out. Patients who had upper limb rupture Patients who had dislocation Patients who had laceration needs to repair
Age
From 18 years old to 140 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method is used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in full-size cast and 5 will be in shorter size groups. A total of 20 blocks will be considered for sample size. In case group bracing up will be done by using half size cast (from the fingers until middle of the forearm) and in the control group it will be done by using a regular cast (from the fingers until one inch below the elbow). General information and medical prescription and same advice are implemented for both groups. Data will analyze by person who is blind to study groups (single blind).
Blinding (investigator's opinion)
Single blinded
Blinding description
Data will analyze by person who is blind to study groups (single blind).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat highway, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-11-14, 1395/08/24
Ethics committee reference number
IR.IUMS.REC 1395.9411307036

Health conditions studied

1

Description of health condition studied
Hand and wrist fracture
ICD-10 code
S62.109A
ICD-10 code description
Fracture of unspecified carpal bone, unspecified wrist, initial encounter for closed fracture

Primary outcomes

1

Description
recovery time
Timepoint
One week, two weeks, four weeks and eight weeks from casting to removal time
Method of measurement
telephone or in-person interviews with patients

2

Description
swelling
Timepoint
One week, two weeks, four weeks and eight weeks from casting to removal time
Method of measurement
telephone or in-person interviews with patients

3

Description
pain
Timepoint
One week, two weeks, four weeks and eight weeks from casting to removal time
Method of measurement
telephone or in-person interviews with patients

4

Description
Union
Timepoint
One week, two weeks, four weeks and eight weeks from casting to removal time
Method of measurement
telephone or in-person interviews with patients

5

Description
Nonunion
Timepoint
One week, two weeks, four weeks and eight weeks from casting to removal time
Method of measurement
telephone or in-person interviews with patients

6

Description
Malunion
Timepoint
One week, two weeks, four weeks and eight weeks from casting to removal time
Method of measurement
telephone or in-person interviews with patients

7

Description
Paresthesia
Timepoint
One week, two weeks, four weeks and eight weeks from casting to removal time
Method of measurement
telephone or in-person interviews with patients

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Half regular size short cast of upper limb in intervention group
Category
Treatment - Other

2

Description
Control group: Regular size of short cast of upper limb in control group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
SHOHADA - E - HAFTE TIR HOSPITAL
Full name of responsible person
Siamak Yasemi
Street address
Emergency Department, SHOHADA - E - HAFTE TIR HOSPITAL, Shahid rajaee Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1464883431
Phone
+98 21 8825 8445
Email
siamakyasami@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakooti
Street address
7th Floor, Department of Internal Medicine, Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Siamak Yasemi
Position
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1464883431
Phone
+98 21 8825 8445
Email
siamakyasami@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad-Reza Yasinzadeh
Position
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6652 5327
Email
yasinzadeh.mr@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Siamak Yasemi
Position
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1464883431
Phone
+98 21 8825 8445
Email
siamakyasami@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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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