Objective: To assess the Union and nonUnion and the infection and rate of return to work in compared with double-plate hybrid therapy in tibial plateau comminuted fracture. design and setting: The study was based on clinical trial to compare the Union number (40) of 20 samples and 20 samples of hybrid double-plate treatment in patients with tibial plateau fractures in the study were split. major inclusin and exclusion: Patients with open fractures and closed tibial plateau comminuted fracture in the study of random pattern based on the hybrid method (external fixator plate on the medial and lateral) and double-plate treatment methods are fixed so that in cases with large pieces comminuted tibial plateau of double-plate and in the case of a hybrid method in the medial and lateral plate is placed external fixator used. intervention: intervention Groups: Fixation of tibial plateau fractures with medial and lateral plate. Contro groupl: tibial plateau fracture fixation with anatomical plate lateral and medial external fixator antero media.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507062798N5
Registration date:2015-12-24, 1394/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-24, 1394/10/03
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 Science
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the treatment effects of hybrid and double plate surgery in tibial plateau fractures
Public title
Comparing the treatment effects of hybrid and double plate surgery in tibial plateau fractures
Purpose
Treatment
Inclusion/Exclusion criteria
exclude critria: Patients with underlying disease; diabetes; immunodeficiency and disease development are excluded.Patients with open fractures and closed tibial plateau comminuted fracture in the study of random pattern based on the hybrid method (external fixator plate on the medial and lateral) and double-plate treatment methods are fixed.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
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
Ethics committee of Mazandaran University Of Medical Science
Street address
Sari, Mazandaran
City
Sari
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MAZUMS.REC.94-1622
Health conditions studied
1
Description of health condition studied
tibial plateaue fracture
ICD-10 code
S82.1
ICD-10 code description
Fracture of upper end of tibia
Primary outcomes
1
Description
pain of the fracture site
Timepoint
2 week / month / two months / 6 months / year / two years
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Union
Timepoint
2 months later, 6 months later
Method of measurement
Radiology
Intervention groups
1
Description
intervention Groups: Fixation of tibial plateau fractures with medial and lateral plate
Category
Diagnosis
2
Description
Contro groupl: tibial plateau fracture fixation with anatomical plate lateral and medial external fixator antero medial
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Masoud Shayestehazar
Street address
Sari, Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University Of Medical Science
Full name of responsible person
Ahmad Ali Enayati
Street address
Sari, Mazandaran
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 Science
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 Univercity Of Medical Science
Full name of responsible person
Dr Vahid Mojrian
Position
Resident Orthopedics
Other areas of specialty/work
Street address
sari, vaviasr bolvar, mazandaran-
City
Sari
Postal code
Phone
+98 11 3337 7169
Fax
Email
dr.vahid.mojrian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Science
Full name of responsible person
Dr Masoud Shayestehazar
Position
orthopedics specialist
Other areas of specialty/work
Street address
Sari, Mazandaran
City
Sari
Postal code
Phone
+98 11 3337 7169
Fax
Email
mshayestehazar@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Orthopedics Research Center, Mazandaran University Of Science
Full name of responsible person
Samira Aghajani
Position
Other areas of specialty/work
Street address
Sari, Mazandaran
City
Sari
Postal code
Phone
+98 11 3337 7169
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)