This randomized controlled clinical trial study was performed on 113 patients referred to Sari Imam Khomeini hospital in 1387-88 because of type I and II tibia open fracture according to Gastillo Criteria and underwent medullary nailiny and external fixation surgery.
After taking informed consent for participation in this trial, patients were divided in two groups randomly. Group A were operated by AO external fixation and group B by internal medullary nailing that were made in U.S.A.
Intra venous prophylactic antibiotic therapy was used for 5days in accordance with infections disease specialists’ advice and then if the wound condition was good, the patient was discharged.
Evaluations after surgery included assessment regarding union, delayed union, non Union and infection. Patients followed weekly for the first month and then monthly during the 6 months after surgery until the union were achieved.
At each visit a questionnaire were filled regarding the side effects. The patients were frequency matched according to sex, age and cause of trauma and type of fracture in three groups and were allocated to the three surgeons who were performing the operations.
At each visit the patients underwent physical exam and a tibia radiography was done for each patient to identify union. The results were compared in the intervention and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809102798N1
Registration date:2010-10-05, 1389/07/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-05, 1389/07/13
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
Mazandarn University of Medical Sciences
Expected recruitment start date
2008-10-22, 1387/08/01
Expected recruitment end date
2009-12-12, 1388/09/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
External fixation compared with medullary nailing in tibia open fracture
Public title
External fixation compared with medullary nailing, two techniques of operation in leg open fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with type I and II open tibial fracture. Exclusion criteria: Patients who have underlying diseases like diabetes, hepatic failure, renal failure, Neurologic, rheumatologic and cardiopulmonary diseases, immunocompromised patients, patients arriving at hospital with more than 24 hours delay, patients who have received corticosteroids or are under chemotherapy, patients who are less than 18 and more than 50 years old and patients who have osteoporosis with any cause
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
113
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
Mazandarn University of Medical Sciences
Street address
Sari
City
Sari
Postal code
Approval date
2009-08-25, 1388/06/03
Ethics committee reference number
88-85
Health conditions studied
1
Description of health condition studied
open tibia fracture
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
Primary outcomes
1
Description
union
Timepoint
weekly for one month and monthly for six month
Method of measurement
radiography
Secondary outcomes
1
Description
complication
Timepoint
weekly for one month and monthly for six month
Method of measurement
radiography
Intervention groups
1
Description
internal medullary nailing in intervention group
Category
Treatment - Devices
2
Description
standard external fixation in control group
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital of Sari
Full name of responsible person
Masoud Shayestehazar
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmadali Enayati
Street address
Vice-chancellor of Research and Technology of Mazandarn 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Masoud Shayestehazar
Position
Associate Professor
Other areas of specialty/work
Street address
Emam hospital of Sari
City
Sari
Postal code
Phone
+98 15 1326 1245
Fax
Email
Mshayestehazar@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoud Shayestehazar
Position
Associate 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)