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Clinical trial study of the assessment of the effect of a long arm cast with Thumb Spica arm cast in the treatment of patients with distal radius fractures without displacement

Protocol summary

Study aim
1- Comparison of the effects of long arm cast and Thumb Spica arm cast on hand reduction 2- Comparison of the effect of long arm cast and Thumb Spica arm cast on the range of motion of the wrist joint.
Design
Clinical trials with a hospital-based and pragmatic control group with parallel, randomized groups, Group 1: Treatment with the long arm cast, Group 2: Treatment with the Thumb Spica arm cast, randomization method Simple randomization, randomization unit: Individual, randomization tool: Random number table, no blinded, The total sample size of 80 patients with distal radius fractures without displacement in 2 groups, clinical trial phase: 3.
Settings and conduct
Distal radius fracture is among the most common fractures of the long bones that are seen in all age groups. Treatment of these fractures in simple cases with displacement or intraarticular fractures inaction, and if the fracture has dislocation may be required surgery. The aim of the study is a comparison of treatment effect in the methods of a long cast and Thumb Spica Cast in the patients with distal radius fractures without displacement. Patients referred to the Baqiyatallah hospital who was diagnosed with distal radius fractures without displacement. Group 1: Treatment with the long arm cast, Group 2: Treatment with the Thumb Spica arm cast, randomization method Simple randomization, randomization tool: Random number table, The total sample size of 80 patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with distal radius fractures without displacement, Exclusion criteria: Patients with Intraarterial fractures of Distal Radius, fracture greater than 20 degrees of dorsal angulation.
Intervention groups
Group 1: Treatment with the long arm cast. Group 2: Treatment with the Thumb Spica arm cast.
Main outcome variables
Hand reduction, The range of motion of the wrist joint.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190128042524N1
Registration date: 2019-03-17, 1397/12/26
Registration timing: retrospective

Last update: 2019-03-17, 1397/12/26
Update count: 0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Hamid Reza Rasouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 3766
Email address
rsr.rasouli@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-09-16, 1397/06/25
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-11-03, 1397/08/12
Scientific title
Clinical trial study of the assessment of the effect of a long arm cast with Thumb Spica arm cast in the treatment of patients with distal radius fractures without displacement
Public title
The assessment of the effect of a long arm cast with Thumb Spica arm cast in the treatment of patients with distal radius fractures without displacement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with distal radius fractures without displacement
Exclusion criteria:
Patients with Intraarterial fractures of Distal Radius Patients with fracture greater than 20 degrees of dorsal angulation
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table
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 Baqiyatallah University of Medical Sciences
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IRB.BMSU.RC.1396.344

Health conditions studied

1

Description of health condition studied
Distal radius fractures without displacement
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius

Primary outcomes

1

Description
Hand reduction
Timepoint
Six weeks after treatment
Method of measurement
DASH questionnaire

2

Description
The range of motion of the wrist joint
Timepoint
Six weeks after treatment
Method of measurement
DASH questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Thumb Spica arm cast for 6 weeks, Spica cast is not gypsum but a kind of casting. Thumb Spica arm cast at the radial surface of the forearm is placed in order to immobilize the thumb and prevent the flexion and extension of the wrist. This splint extends from the tip of the thumb to the proximal forearm. Place the forearm in a neutral position, while the wrist has a 20-degree extension and the shoulder is bent slightly.
Category
Treatment - Devices

2

Description
Control group: Long arm cast for 6 weeks, long arm cast is a cast of the forearm in order to relieve articulation and joint wrists in the distal radius fracture.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency department of Baqiyatallah hospital
Full name of responsible person
Sadrollah Mahmoudi
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee St, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
droserik@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hamid Reza Rasouli
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
pajuhesh_trauma@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Sadrollah Mahmoudi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
droserik@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Sadrollah Mahmoudi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
droserik@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Sadrollah Mahmoudi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
droserik@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Print article
When the data will become available and for how long
8 months
To whom data/document is available
Medical students
Under which criteria data/document could be used
Print article
From where data/document is obtainable
Sadrollah Mahmoudi
What processes are involved for a request to access data/document
Question
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