Comparing outcome of forearm diaphyseal fractures that treated by selective screw placement compression plating (4cortex) with whole screw placement in patients older than 18 years
In this trial, 124 patients above 18 years old with closed forearm diaphyseal fractures type A and B (OTA), will be entered and will be operated randomly in two groups of 64 patients. In one group fixation with plate and selective screw fixation and in another group fixation with plate and whole screw placement will be done. Patients post op follow up is at 3, 6, 12 and 16 weeks after surgery and rate of infection, nonunion, time of union will be compared between two groups. A union criterion is healing of 3 cortex of 4 cortex of bone without localized tenderness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010144940N1
Registration date:2010-11-28, 1389/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-28, 1389/09/07
Registrant information
Name
Saeed Sabahi
Name of organization / entity
Ahwaz Jondi Shapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1391 2943
Email address
sabahi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jondi Shapour University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing outcome of forearm diaphyseal fractures that treated by selective screw placement compression plating (4cortex) with whole screw placement in patients older than 18 years
Public title
Adult forearm diaphyseal fracture fixation with plate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients above 18 years old with closed diaphyseal foerarm fractures type A and B (OTA). Exclusion criteria: patients above 70 years or under 18 years old, type C (OTA) fractures, open fractures.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
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
Jondi Shapour University of Medical Sciences
Street address
Golestan street
City
Ahwaz
Postal code
Approval date
2010-01-29, 1388/11/09
Ethics committee reference number
4513//8/20/پ
Health conditions studied
1
Description of health condition studied
Forearm diaphyseal fractures
ICD-10 code
S52.4
ICD-10 code description
Fracture of shafts of both ulna and radius
Primary outcomes
1
Description
union
Timepoint
12 and 16 weeks after surgery
Method of measurement
physical exam and radiography
Secondary outcomes
1
Description
Time of union
Timepoint
12 and 16 weeks after surgery
Method of measurement
time of union according to radiography and physical exam
2
Description
infection
Timepoint
3, 6, 12 and 16 weeks after surgery
Method of measurement
sign of infection such as erythema, tenderness, dischrge
Intervention groups
1
Description
fixation with plate and selective screw placement
Category
Treatment - Surgery
2
Description
fixation with plate and whole screw placement
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini and Razi hospital of Ahwaz
Full name of responsible person
Street address
Azadegan street
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy ahwaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr. Abdolhosein Mehdinasab
Street address
Imam khomeini hospital
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy ahwaz Jondi Shapour 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
Ahwaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr. Saeed Sabahi
Position
Orthopaedic resident
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahwaz
Postal code
Phone
+98 912 549 5787
Fax
Email
sabahi@ajums.ac.ir , saeedsabahi4747@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr. Abdolhosin Mehdinasab
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahwaz
Postal code
Phone
+98 916 111 1052
Fax
Email
dr.mehdinasab@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr. Saeed Sabahi
Position
Orthopaedic resident
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahwaz
Postal code
Phone
+98 61 1391 2943
Fax
+98 18 1424 6666
Email
sabahi@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)