Percutaneous vertebroplasty under imaging guide will be conducted during a 15 months period in Emam Reza Hospital of Tabriz for about 30 patients with osteoporotic compression fracture, painful hemangioma, metastasis and multiple myeloma of vertebral bodies. Before and after procedure pain and functional disability of patients willbe measured by Visual Analogue Scale and Oswestry low back pain Questionare.
Any complication such as leakage of cement and canal stenosis will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902033778N1
Registration date:2010-05-20, 1389/02/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-05-20, 1389/02/30
Registrant information
Name
Masoud Nemati
Name of organization / entity
Tabriz Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4986
Email address
nematima@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research department of Tabriz University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-08-22, 1390/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Short term clinical outcome of percutaneous vertebroplasty
Public title
short term clinical outcome of percutaneous vertebroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
-age over 50 years
-osteoporotic compression fracture of vertebrae
-painful vertebral hemangioma
-painful vertebral metastasis
-painful vertebral involvement by multiple myeloma
exclusion criteria:
-new vertebral fractures(less than 2 weeks)
-old vertebral fractures(more than one year)
-sever compression of vertebral body(reduction of more than 80% percent of height of the vertebra)
-myelopathy
-focal neurologic defects
-bleeding disorders
Age
From 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
local ethic committee
Street address
tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2010-02-23, 1388/12/04
Ethics committee reference number
5/4/9300
Health conditions studied
1
Description of health condition studied
Metastasis to vertebrae with or without compression
ICD-10 code
C79.5
ICD-10 code description
metastasis to vertebrae
2
Description of health condition studied
Osteoporosis with compression fracture
ICD-10 code
M80
ICD-10 code description
osteoporosis with compression fracture
3
Description of health condition studied
Multiple Myeloma of vertebrae with or without compression
ICD-10 code
M82.0
ICD-10 code description
Multiple Myeloma of vertebrae
4
Description of health condition studied
Hemangioma of vertebrae with or without compression
ICD-10 code
D18.0
ICD-10 code description
hemangioma of vertebrae
Primary outcomes
1
Description
Pain
Timepoint
one month after cement injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Functional disability after vertebroplasty
Timepoint
immediately , one week and one month after injection of cement
Method of measurement
Oswestry Low Back Pain Questionare
Intervention groups
1
Description
cement injection in vertebral body under guidance of CT scan
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Shahrzad Zarayan
Street address
golgasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research department of Tabriz university of medical sciences
Full name of responsible person
Dr. Ostad Rahimi
Street address
Education Building- Tabriz university
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research department of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Shahrzad Zarayan
Position
resident of radiology
Other areas of specialty/work
Street address
Emam Reza Hospital- department of radiology
City
Tabriz
Postal code
Phone
+98 41 1334 5591
Fax
Email
drrahmani95764@yahoo.comnematimasoud1@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Masoud Nemati
Position
Radiologist
Other areas of specialty/work
Street address
Department of Radiology- Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 5591
Fax
Email
nematima@tbzmed.ac.irnematimasoud1@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Shahrzad Zarayan
Position
Resident of Radiology
Other areas of specialty/work
Street address
Department of Radiology- Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 5591
Fax
Email
drrahmani95764@yahoo.comnematimasoud1@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)