Comparative study of the effectiveness of the PLGA( poly lactic Co-glycolic acid) system loaded with Deferoxamine with Core decompression alone in treatment of patients with early stage of Osteonecrosis of the femur head
Evaluation of the efficacy of Core Decompression (CD) with PLGA loaded with deferoxamine in recovery of patients with early stage of osteonecrosis of the femoral head(ONOFH)
Design
Clinical trial with control group with parallel groups and Randomized method is simple and using random number table
Settings and conduct
Patients who come to the Shafa Yahyaian Hospital with hip pain and ONOFH is diagnosed After checking the inclusion and exclusion criteria and obtaining consent, they will be included in the study.
Participants/Inclusion and exclusion criteria
Age > 18
Patients with early stages of ONFH Association Research Circulation Osseous ( ARCO) stage 1 or 2
Idiopathic, steroid and alcohol induced, associated with lupus and sickel cell anemia
Intervention groups
Patients in the intervention group after admission in the operating room according to the location of the osteonecrosis with fluoroscopy guide will first be placed under the CD, and immediately the PLGA -defroxamine system will be placed in the same place.
Patients in the control group after admission in the operating room according to the location of the osteonecrosis with fluorescope guide will be only under the CD at the specified location .
Main outcome variables
Femoral head necrosis rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161121031003N3
Registration date:2019-04-16, 1398/01/27
Registration timing:retrospective
Last update:2019-04-16, 1398/01/27
Update count:0
Registration date
2019-04-16, 1398/01/27
Registrant information
Name
Kaveh Gharanizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2000
Email address
gharanizadeh.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of the PLGA( poly lactic Co-glycolic acid) system loaded with Deferoxamine with Core decompression alone in treatment of patients with early stage of Osteonecrosis of the femur head
Public title
Effect of PLGA( poly lactic Co-glycolic acid) system loaded with Deferoxamine in Osteonecrosis of the femur head
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 18 years
ARCO stage 1 or 2
Idiopathic, steroid and alcohol induced, associated with lupus and sickel cell anemia
Exclusion criteria:
Age> 50 years
previous history of pelvic surgery
An underlying condition that prevents surgery such as heart or lung disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized method is simple and using random number table, patients are divided into two groups: intervention and control
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 Iran University of Medical Sciences
Street address
Mojahedin eslam
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.IUMS.FMD.REC.1397.281
Health conditions studied
1
Description of health condition studied
osteonecrosis of the femoral head
ICD-10 code
M91.9
ICD-10 code description
Juvenile osteochondrosis of hip and pelvis, unspecified
Primary outcomes
1
Description
Femoral head necrosis rate
Timepoint
At the beginning of the study (before the intervention) and 6 months and 12 months after the intervention, the hip joint MRI will be performed.
Method of measurement
MRI
Secondary outcomes
1
Description
Clinical status of patients
Timepoint
All patients will be examined prior to the intervention and at intervals of 2 weeks and 1-3-6 and 12 months after the intervention
Method of measurement
modified merle dAubigne scale
2
Description
pain
Timepoint
All patients will be examined prior to the intervention and at intervals of 2 weeks and 1-3-6 and 12 months after the intervention
Method of measurement
visual analog score
3
Description
cysts and subchondral sclerosis
Timepoint
All patients will be examined prior to the intervention and at intervals of 2 weeks and 1-3-6 and 12 months after the intervention
Method of measurement
pelvic radiography
4
Description
The amount of collapse in femural head
Timepoint
At the beginning of the study (before the intervention) and 6 months and 12 months after the intervention
Method of measurement
Pelvic CT Scane
Intervention groups
1
Description
Intervention group: Patients in the intervention group after admission in the operating room according to the location of the osteonecrosis indicated in radiography, MRI and CT Scan with fluoroscopy guide will first be placed under the core decopression, and immediately the PLGA -defroxamine system will be placed in the same place. to prepare the PLGA -defroxamin system In this study, a scaffold of PLGA with a molecular weight of 25 kilodalton from Sigma Company is prepared using salt-leaching technique. Then, on each PLGA scaffold, 500 miligrams of dexroxamine are loaded.
Category
Treatment - Surgery
2
Description
Control group: Patients in the control group after admission to the operating room according to the location of the osteonecrosis indicated in the radiography, MRI and CT scan with fluorescope guide will be located only under the core decopression at the specified location
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Sajad noori Garavand
Street address
Mojahedin Eslam St, District 12, Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 3354 2005
Email
gharanizadeh.k@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sajad Noori Garavand
Street address
Mojahedin Eslam St, District 12, Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 3354 2005
Email
gharanizadeh.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sajad Noori Garavand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mojahedin Eslam St, District 12, Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 3354 2005
Email
Gharanizadeh.k@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Doctor Mohammad Ali Sharifi
Position
pharmacologist/ faculty member of Iran university of medical scienses
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Iran University of Medical Sciences, Between Chamran and Sheikh Fazlallah, hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 3354 2000
Fax
Email
Sharifalim@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sajad Noori Garavand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mojahedin Eslam St, District 12, Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 3354 2005
Fax
Email
sajadnoori85@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information in both groups includes changes in MRI, CT Scan and radiography, as well as changes in VAS and modified merle dAubigne scale Publishable.
When the data will become available and for how long