Protocol summary

Summary
This study, which was performed as a double blind randomized and controlled clinical trial, aimed to evaluate the efficacy of percutaneous vertebroplasty (PV) for controlling pain and improving the quality of life (QOL) as compared to the optimal medical treatment (OMT) in vertebral compression fractures (VCFS). 85 patients were randomly divided into two groups, a control group including 45 patients who were treated by optimal medical therapy and a study group including 40 patients who underwent PV for vertebral fractures beside the OMT for preventing of osteoporosis progress. Patients were evaluated by radiography, MRI and CTS and were under 1 week, 2, 6, 12, 24 and 36 months of clinical examinations. All patients with osteoporotic VCF and a height loss of the vertebral body (10-70%), low back pain in the clinical examination, progressive mild deformity, no response to the conventional medical therapy were included for performing PV and 1-3 cc polymethylmethacrylate was injected into the vertebral body according to the fracture type and vertebral condition by specific devices such as Technimed, France or MENDEC Spine Kit, Verona, Italia (www.tecres.it) as the intervention. Patients with coagulation defects, local or systemic infection, neural disorders, defect in the posterior wall of the vertebral body, painless VCF, severe spinal deformity were also excluded. Radiography was also taken at 2 and 6 months, 1, 2 and 3 years after the beginning of the treatment to show a decrease in the treatment period and medical expenses in the PV group in comparison with the OMT group

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804252193N1
Registration date: 2009-11-10, 1388/08/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-11-10, 1388/08/19
Registrant information
Name
Majid Reza Farrokhi
Name of organization / entity
Shiraz Neurosciences Research Center, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 4508
Email address
neuroscien@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz Neurosciences Research Center-Vice Chancellor for Research Affairs of Shiraz University of Medical Sciences
Expected recruitment start date
2005-12-21, 1384/09/30
Expected recruitment end date
2008-12-20, 1387/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of results of PV (percutaneous vertebroplasty) and conservative treatment in patients with osteoporotic VCF (vertebral compression fractures)
Public title
The comparison of results of PV (percutaneous vertebroplasty) and conservative treatment in patients with osteoporotic VCF (vertebral compression fractures)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: osteoporotic VCF patients with a height loss of the vertebral body (10-70 percents), associated with low back pain in clinical examination, progressive mild deformity, presenting no response to the optimal medical therapy Exclusion criteria: coagulation disorders, local or systemic infection, neural disorders, defect in the posterior wall of the vertebral body, painless VCF (vertebral compression fractures), severe deformity
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Affairs, Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand boulevard, Shiraz
City
Shiraz
Postal code
713451978
Approval date
2009-09-26, 1388/07/04
Ethics committee reference number
CT-88-4726

Health conditions studied

1

Description of health condition studied
Osteoporotic Vertebral Compression Fractures
ICD-10 code
S32.0
ICD-10 code description
Fracture of Lumbar Vertebra

Primary outcomes

1

Description
Fast treatment of osteoporotic vertebral compression fractures by PV (percutaneous vertebroplasty)
Timepoint
one week, 2, 6, 12, 24, and 36 months after intervention
Method of measurement
Radiography

Secondary outcomes

1

Description
Medical expenses
Timepoint
2 months, 6 months, 1 year, 2 years, and 3 years after intervention
Method of measurement
Cost of medical care

Intervention groups

1

Description
Injecting 1-3cc (based on the type of vertebral fractures) of polymethylmethacrylate by PV technique
Category
Treatment - Other

2

Description
Long rest, using painkillers and orthotic brace, prescription of calcium at least 500 mg twice a day and Alendronate
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Dr. Majid Reza Farrokhi
Street address
Shiraz Neurosciences Research Center, Chamran Hospital, Shiraz
City
Shiraz

2

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr.Majid Reza Farrokhi
Street address
Zand st., Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research Affairs of Shiraz University of Medical Sciences, Apadana Tajhiz Gostar
Street address
Vice-Chancellor for Research Affairs, central building of Shiraz University of Medical Sciences, Zand boulevard, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz Neurosciences Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Majid Reza Farrokhi
Position
Neurosurgeon, Fellowship of Spinal Surgery, Director of Shiraz Neurosciences Research Center
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center, Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
farokhim@sums.ac.ir,farrokhi_drmr@yahoo.com
Web page address
http://snrc.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Neurosciences Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Majid Reza Farrokhi
Position
Neurosergeon, Fellowship of Spinal Surgery
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center, Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
farokhim@sums.ac.ir,farrokhi_drmr@yahoo.com
Web page address
http://snrc.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Neurosciences Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Mahshid Hosseini
Position
The Expert of Research Affairs of the Center
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center, Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
neuroscien@sums.ac.ir , hosseini_2m@yahoo.com
Web page address
http://snrc.sums.ac.ir

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
Loading...