To compare the results of internal fixation of midshaft clavicular fractures by pin and plate. Design: a randomized controlled clinical trial. Patients: 50 cases (42 male and 8 female) with clavicular fractures will be assigned to two groups consist of 25 persons in each. Inclusion criteria will be: the age of 18 to 60 years, Fracture of clavicle. Exclusion criteria will be: Open fracture of clavicle, fracture and nerve damage in the same side of the upper limb. Intervention: we will operate the first patient with smooth 3.5 mm pin and the other with 3.5 mm plate and will continue the operations in the same manner. The patients will be followed up until complete union. Main outcomes: As long as 6 months follow-up, treatment results and complications of treatment with these two methods will be reviewed and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105165920N3
Registration date:2011-06-07, 1390/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-07, 1390/03/17
Registrant information
Name
Sulmaz Natanj
Name of organization / entity
Jundishapour university of medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 2344
Email address
natanj.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapour University Of Medical Sciences
Expected recruitment start date
2008-09-02, 1387/06/12
Expected recruitment end date
2010-09-03, 1389/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the results of internal fixation of midshaft clavicular fractures by pin and plate
Public title
Surgical fixation of clavicular fracture in the appropriate field
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the age of 18 to 60 years, Fracture of clavicle. Excusion criteria: Open fracture of clavicle, fracture and nerve damage in the same side of the upper limb.
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:
50
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
Jundishapour University Of Medical Sciences
Street address
Golestan Blvrd
City
Ahvaz
Postal code
Approval date
2010-05-31, 1389/03/10
Ethics committee reference number
ETh005
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
Timepoint
4,6,8 weeks and 6 months postoperatively
Method of measurement
Using X ray of clavicle
2
Description
Shoulder Score
Timepoint
6 months postoperatively
Method of measurement
Using Shoulder Scores
Secondary outcomes
1
Description
Operation time
Timepoint
During surgery
Method of measurement
Based on surgery duration in minutes
2
Description
Bleeding
Timepoint
During surgery
Method of measurement
Based on the amount of intraoperative bleeding according ml
3
Description
Infection
Timepoint
2,4,6,8 weeks and 6 months postoperatively
Method of measurement
Based on clinical symptoms such as inflammation and purulent discharge from wounds or radiographic signs such as seqestrom
4
Description
Symptomatic hardware
Timepoint
6 months postoperatively
Method of measurement
Based on patient complaints
Intervention groups
1
Description
Internal fixation with pin
Category
Treatment - Surgery
2
Description
Internal fixation with plate
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Sharareh Shalamzari
Street address
Ahvaz Emam Khomeini hospital
City
Ahvaz
2
Recruitment center
Name of recruitment center
Ahvaz Emam Khomeini hospital
Full name of responsible person
Sharareh Shalamzari
Street address
Ahvaz Emam Khomeini hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi, Vice-Chancellor For Research
Street address
Vice-Chancellor For Research, Jundishapour University Of Medical Sciences, Golestan Blvrd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapour 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
Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Saaid Tabatabaei
Position
Assistant professor of orthopedic surgery
Other areas of specialty/work
Street address
Razi hospital
City
Ahvaz
Postal code
Phone
00986113373022-00986113910857
Fax
Email
www.saaidt1379@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Saaid Tabatabaei
Position
Assistant professor of orthopedic surgery
Other areas of specialty/work
Street address
Razi hospital
City
Ahvaz
Postal code
Phone
00986113373022 - 00986113910857
Fax
Email
www.saaidt1379@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapour University of Medical Sciences
Full name of responsible person
Sharareh Shalamzari
Position
Resident of Orthopedic Surgery
Other areas of specialty/work
Street address
Ahvaz Emam Khomeini hospital
City
Ahvaz
Postal code
Phone
Fax
Email
sh_shalamzari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)