Protocol summary

Summary
Aim of this study effect of ‎‏ ‏knee arthroplasty on hindfoot alignment in patients with ‎severe genuvarum and genuvalgum.This study is clinical trial ,self –controlled .This study 83 patient have arthroplasty .‎Inclusion criteria: age 50 and more; sever osteoarthritis.Exclusion criteria: neuromuscular disease; Previous knee infection that leads to deformity of knee; Knee joint destruction due to underlying disease except Knee osteoarthritis; previous fracture of knee; systemic arthritis.We recorded angle and angle correction of ‎hind foot before and 6 months after surgery by long axial radiography.We measure 83 patients with angle of hind foot and correct angle by by long axial radiography before ‎surgery in control group. We measure 83 patients in control group angle of hind foot by long axial ‎radiography 6 month after ‎surgery in intervention group.‎‏ ‏

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102230441N1
Registration date: 2016-12-14, 1395/09/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-14, 1395/09/24
Registrant information
Name
Gholamreza Azarnia
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3312 4811
Email address
ghr.azarnia@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research, Arak University Of Medical Sciences
Expected recruitment start date
2016-07-09, 1395/04/19
Expected recruitment end date
2018-07-10, 1397/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ‎‏ ‏knee arthroplasty on hindfoot alignment in patients with ‎severe genu varum and genu valgum in Amiralmomenin hospital in Arak
Public title
The effect of ‎‏ ‏knee surgery in patients with ‎severe osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 50 and more; severe osteoarthritis. Exclusion criteria: neuromuscular disease; Previous knee infection that leads to deformity of knee; Knee joint destruction due to underlying disease except Knee osteoarthritis; previous fracture of knee; systemic arthritis.
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 83
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Arak University Of Medical Sciences
Street address
Arak, Sardasht, Basij Square, Payambar Azam Complex, Reaserch Center
City
Arak
Postal code
848176941
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
IR.ARAK.MU.REC.1395.57

Health conditions studied

1

Description of health condition studied
severe genu varum and genu valgum
ICD-10 code
Q74.1
ICD-10 code description
Congenital malformation of knee

Primary outcomes

1

Description
Angle of orthopedic
Timepoint
before and 6 months after surgery
Method of measurement
long axial radiography

Secondary outcomes

empty

Intervention groups

1

Description
We measure 83 patient with angle of hind foot and correct angle by by long axial radiography before surgery in control group.
Category
Treatment - Drugs

2

Description
We measure 83 patients in control group angle of hind foot by long axial radiography 6 month after ‎surgery in intervention group.‎
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Hosseinali Hadi
Street address
Amiralmomenin hospital, Sardasht, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice Chancellor for Research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Arak 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
Arak University Of Medical Sciences
Full name of responsible person
Dr Gholamreza Azarnia
Position
Resident of Orthopedic
Other areas of specialty/work
Street address
medicine department, Payambarazam complex, Basij square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
ghr.azarnia@arakmu.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Hosseinali Hadi
Position
Orthopedist
Other areas of specialty/work
Street address
Amiralmomenin hospital, Basij squre, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
dr.hadi@arakmu.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Gholamreza Azarnia
Position
resident of orthopedic
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
ghr.azarnia@arakmu.ac.ir
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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