The design study is a randomized intervention(comparing two surgical methods)
Objective: Comparison between external fixator and pins &plasters in the
treatment of distal radius fractures in patients referred to Imam Khomeini Hospital Sari
Inclusion criteria: Patients should have bone maturation (at least 18 years of age), have distal radius fractures , the range of age between 18 and 70 years and don’t have any systemic disease that can interfere in the surgical treatment such as osteoporosis.
Exclusion criteria: patients with diseases interfering surgical treatment , age morethan 70 or under 18 or have nerve involvement before surgery ,have a history of previous fracture in the same radius and patients tend to have may not participate in the study were excluded
In this study, we select 100 samples. The 100 patients randomly divided into two groups of 50 patients each are under a kind of surgery are mentioned.
a study of 100 cases of distal radius fractures were made, 50 patients with external fixator technique and 50 patients with pins and plaster technique underwent surgery and eventually will compare patient information And in this comparison is done within six months
Primary Outcome: Based on previous studies seem who were treated by percutaneous fixation have earlier return to their daily routine but the number of pins and plaster studies have preferred.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103072798N2
Registration date:2011-05-24, 1390/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-24, 1390/03/03
Registrant information
Name
Masoud Shayestehazar
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 7230
Email address
mshayestehazar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-01-20, 1389/10/30
Expected recruitment end date
2011-07-21, 1390/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two Surgical Methods , External Fixator and Pin & Plaster in Treatment of Distal Radius Fractures
Public title
Comparison of two Surgical Methods in Treatment of Hand Fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients should have bone maturation (at least 18 years of age), have distal radius fractures , the range of age between 18 and 70 years and don’t have any systemic disease that can interfere in the surgical treatment such as osteoporosis.
Exclusion criteria: patients with diseases interfering surgical treatment , age morethan 70 or under 18 or have nerve involvement before surgery ,have a history of previous fracture in the same radius and patients tend to have may not participate in the study were excluded
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mazandaran University of Medical Sciences
Street address
Building No.2 , Mazandaran University of Medical Sciences,moallem square
City
Sari
Postal code
Approval date
2011-01-19, 1389/10/29
Ethics committee reference number
89-144
Health conditions studied
1
Description of health condition studied
Distal Radius Fructures
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
malunion
Timepoint
6 Month Follow
Method of measurement
Hand Radiography
Secondary outcomes
1
Description
Wrist Motion Limitation
Timepoint
6 month
Method of measurement
Examination
2
Description
Painfulness
Timepoint
6Month
Method of measurement
Examination
3
Description
Nerve Damage
Timepoint
6Month
Method of measurement
Examination
Intervention groups
1
Description
Control:50 Patients with Pins and Plaster Technique underwent Surgery
Category
Treatment - Surgery
2
Description
Intervention:
50 patients with external fixator technique underwent surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital of Sari
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
Vice- Chancellor of Research and Thecnology of Mazandaran University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr masoud Shayestehazar
Position
Orthopedic specialist
Other areas of specialty/work
Street address
moallem square , No.2 Building Mazandaran University of Medical Sciences
City
sari
Postal code
Phone
+98 911 151 5654
Fax
Email
MSHAYESTEHAZAR@MAZUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masuod Shayestehazar
Position
Associated Professor
Other areas of specialty/work
Street address
Emam Hospital Of Sari
City
Sari
Postal code
Phone
+98 15 1325 7230
Fax
Email
Mshayestehazar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masuod Shayestehazar
Position
Associated Professor
Other areas of specialty/work
Street address
City
Sari
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)