A-Patients selection :cases are selected among patients referred to knee clinic of shafa yahyaian hospital according to inclusion criteria:1.age:20-35 yrs 2.sex:male 3.femur and tibia anatomic axis difference <0deg
4.No meniscal or ligament injury 5.No chondral lesion 6.No ligament laxity 8.No bony or systemic diseases9.Normal BMI(18-25) 9.No anatomic or mechanical axis disorders in lower limb except for genovarum
B-Radiologic assessment:1.Xray:AP,lateral,patella view,alignment view 2.knee MRI 3.knee CT scan(3D with reconstruction) 4.stance phase dynamic fluoroscopy of knee
C-computerized modeling and finit element study:after transferring data to a specific computer with use of simpleware software ,finit element study of stress distribution in compartments of knee will be done.
D-High tibia osteotomy:open wedge high tibia osteotomy with preservation of lateral cortex hing and iliac crest auto bone graft will be done.
E-Radiologic assessment 6 month after surgery: after complete union of osteotomy site and complete rehabilitation and return to pre operative level of function and normal gait pattern,radiologic assessment in section B will be done.
F-Computerized modeling and finit element study
G-The results in section C and section F will be compared and discussed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109037464N1
Registration date:2012-05-08, 1391/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-08, 1391/02/19
Registrant information
Name
Mohammad Ali Enayatollahi
Name of organization / entity
Shafa Yahyaian Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2001
Email address
m-jabalameli@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Univercity of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Finit Element Study of Stress Distribution in Varus Knee-before and after high tibia osteotomy
Public title
A Finit Element Study of Stress Distribution in Varus Knee -before and after high tibia osteotomy
Purpose
Health service research
Inclusion/Exclusion criteria
1.age:20-35 yrs 2.sex:male 3.femur and tibia anatomic axis difference <0deg
4.No meniscal or ligament injury 5.No chondral lesion 6.No ligament laxity 8.No bony or systemic diseases9.Normal BMI(18-25) 9.No anatomic or mechanical axis disorders in lower limb except for genovarum
Age
From 20 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
2
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran university of medical science
Street address
6th floor gentral university organization ,ghods st.keshavarz blvd.
City
tehran
Postal code
Approval date
2011-10-16, 1390/07/24
Ethics committee reference number
90/ص/130/1442
Health conditions studied
1
Description of health condition studied
genuvarum
ICD-10 code
M21.1(6)
ICD-10 code description
varus deformity,not elsewhere classified
Primary outcomes
1
Description
knee stress distribution
Timepoint
before and 6 month after high tibia osteotomy
Method of measurement
finit element study with use of simpleware software
Secondary outcomes
1
Description
genuvarus correction
Timepoint
6 month after high tibia osteotomy
Method of measurement
X-ray:alignment view
Intervention groups
1
Description
High tibia osteotomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
shafa yahyaian hospital
Full name of responsible person
mohammad ali enayatollahi
Street address
baharestan sq. tehran
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
tehran university of medical science
Full name of responsible person
doctor fotuhi
Street address
6th floor,central university organization,ghods st. keshavarz blvd.
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?