Objectives: Comparison of clinical outcomes of undisplaced distal radius fractures treated with casting and bandaging. Design: Randomized, single-center, phase II trial. Setting and conduct: bandage and casting method is performed randomly into two groups. Disability of patient is assessed by the measure of Dash after six weeks. Participants including major eligibility criteria: Inclusion criteria include patients Patients with extra-articular distal radius fractures; exclusion criteria include lack of cooperation. Intervention: bandage and casting method is performed randomly into two groups. main outcome measures variable: Inability of patients after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040627247N1
Registration date:2016-09-20, 1395/06/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-20, 1395/06/30
Registrant information
Name
Reza Farahnak
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3323 4464
Email address
farahnak.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-19, 1395/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical outcomes of two methods of casting and bandaging in the treatment of fractures without displacement of distal radius
Public title
Casts and bandages in fractures without displacement of the distal radius
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients Patients with extra-articular distal radius fractures. Exclusion criteria: lack of cooperation.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done by using a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jondishapour University of Medical Sciences
Street address
Vice chancellor for research, Ahvaz Jondishapour University of Medical Sciences, City University, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
ir.ajums.rec.1394.587
Health conditions studied
1
Description of health condition studied
undisplaced distal radius fractures
ICD-10 code
S52.6
ICD-10 code description
Fracture of lower end of both ulna and radius
Primary outcomes
1
Description
Amount of inability
Timepoint
Before the intervention, three weeks after intervention and 6 weeks after the intervention.
Method of measurement
According to DASH score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: casting
Category
Rehabilitation
2
Description
Intervention group: bandaging
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Reza Farahnak
Street address
Golestan Hospital, Farvardin Avenue, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Dr Nader Saki
Street address
Vice chancellor for research, Ahvaz Jondishapour University of Medical Sciences, City University, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jondishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan Hospital
Full name of responsible person
Hamid Reza Arti
Position
Head of Golestan Hospital
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3014
Fax
Email
golestanhospital@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan Hospital
Full name of responsible person
Hamid Reza Arti
Position
Head of Golestan Hospital
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3014
Fax
Email
golestanhospital@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Reza Farahnak
Position
Resident of orthopedic
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
farahnak.r@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)