The comparison of the effect of surgical treatment of midshaft clavicle fracture with plate versus non operative treatment in imam Golestan and Razi hospital during 1390-1392
The aim of this study is comparison of the effect of surgical treatment of midshaft clavicle fracture with plate versus non surgical treatment. In this study, 70 patients with fractures of the medial clavicle referred to the emergency ward of Razi and Emam hospitals, are enrolled into the study and after a thorough explanation about the complications of treatment are randomly assigned to 2 groups. The patients in two groups are matched for age, sex, and fracture type. Clinical and radiological evaluation and follow up will be done for 3 months until a full-time union. At the end of treatment DASH score questionnaire will be completed and the results of examinations and questionnaires in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061113633N1
Registration date:2013-07-14, 1392/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Hosein Mokarrami
Name of organization / entity
Ahwaz joundishapour university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 25 3776 8167
Email address
mokarrami.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Ahwaz Joundishapour University of Medical Siences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of surgical treatment of midshaft clavicle fracture with plate versus non operative treatment in imam Golestan and Razi hospital during 1390-1392
Public title
The comparison of the results of surgical and non surgical treatment of clavicle fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: fractured clavicle midshaft, age under 60 years old over 18 years
Exclusion criteria: clavicular fractures elsewhere; ages under 18 years of age to 80 years.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ahwaz Joundishapour University of Medical Siences
Street address
Ground Floor, Department of Research and Technology,City University
City
Ahvaz
Postal code
6135715794
Approval date
2013-03-09, 1391/12/19
Ethics committee reference number
139207
Health conditions studied
1
Description of health condition studied
Fracture of clavicle
ICD-10 code
S42.0
ICD-10 code description
Fracture of clavicle
Primary outcomes
1
Description
Union of clavicle fracture
Timepoint
Every 6 month
Method of measurement
Serial x Ray
2
Description
Physical function
Timepoint
Every 6 month
Method of measurement
Physical exam and DASH score
3
Description
Time to go back to work
Timepoint
Every 6 month
Method of measurement
Based on day
4
Description
Cost of treatment
Timepoint
Every 6 month
Method of measurement
Spending on Rials
5
Description
Restriction movement
Timepoint
Every 6 month
Method of measurement
Physical examination and calculation of shoulder joint range of motion