Protocol summary

Study aim
The study of the results of using Shoe inserts in patients with ION of femoral head referred to Hip Clinic of Shohada Hospital of Tabriz in 2017-2018.
Design
Randomaised clinical trial
Settings and conduct
In this study, in coordination with other masters of Tabriz Shohada Hospital, referrals of patients, adult patients referred to the hip clinic with Femoral head ION diagnosis will be studied. First, patients who are not willing to undergo surgery will be divided into control and intervention groups. In this group In addition to all the usual therapies, shoe's insert will be prescribed, and in the the control group only the usual therapeutic will be taken. In this study, patients classified in FICAT Stage 1 and 2 will be included in the study and will not be included in patients undergoing surgery for the ION in the past year. In this study, each patient will be monitored and studied for one year. Due to the necessity of frequent referral to follow up, for each patient referral, the forms of HHS and FICAT will be filled in for analysis. That's why this research may require one and a half years to collect data.
Participants/Inclusion and exclusion criteria
Patients with ION of the femoral head that won’t surgery procedures. But if they want, they will be deleted from the study.
Intervention groups
Patients with ION of the femoral head that use shoe inserts
Main outcome variables
Standard forms FICAT and HHS and shoe’s insert

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180714040468N1
Registration date: 2019-07-20, 1398/04/29
Registration timing: retrospective

Last update: 2019-07-20, 1398/04/29
Update count: 0
Registration date
2019-07-20, 1398/04/29
Registrant information
Name
Mahdi Pashazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3381 7016
Email address
dr.m.pashazadeh.85@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
2019-06-22, 1398/04/01
Scientific title
Investigating the Role of Silicone Therapy on Clinical and Radiological Symptoms in Patients with Idiopathic Osteonecrosis of the Femoral Head. A Clinical Trial study.
Public title
medical insert in patients with osteonecrosis of the femur head
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dissatisfaction with surgery
Exclusion criteria:
Failure to perform hip surgery in the past year
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 17
Actual sample size reached: 14
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in coordination with other masters of Tabriz Shohada Hospital, referrals of patients, adult patients referred to the hip clinic with Femoral head ION diagnosis will be studied. First, patients who are not willing to undergo surgery will be divided into control and intervention groups. In this group In addition to all the usual therapies, shoe's insert will be prescribed, and in the the control group only the usual therapeutic will be taken. In this study, patients classified in FICAT Stage 1 and 2 will be included in the study and will not be included in patients undergoing surgery for the ION in the past year. Of course, if during the course of the study, patients in either group need to undergo a surgical procedure will do. Femoral head ION may have different causes, and patients have been suffering from this disease for several reasons, and factors such as the use of Drugs, smoking, the amount of daily activity, alcohol consumption, and various types of ION-causing illnesses are considered as confounding factors in the study. However, by random categorization of patients between the two groups, this problem will be addressed in the study In this study, each patient will be monitored and studied for one year. Due to the necessity of frequent referral to follow up, for each patient referral, the forms of HHS and FICAT will be filled in for analysis. That's why this research may require one and a half years to collect data. Shoe's insert is designed for each patient in the center of the orthosis of Tabriz Shohada Hospital. Due to the fact that the use of medical flooring is not a proven method, the cost of the treatment is costly from the patient organization It is necessary to explain that in this study, none of the patients will know about the prescribing of shoe's insert to others, and because of the interpretation of the results based on the radiographic changes in the disease and standard scores, there is no need for researchers to blind. Considering that no similar studies have ever been done in this regard, "all patients referred to the Shohada Hospital Hip Clinic will be studied within six months, and the sampling will continue until the end of the period. Subsequently, the sampling volume In this study, randomized and in the form of allocation of patients to control and intervention groups after determining the criteria for entering and leaving the study by Blind Randomization software, thus, considering the randomness of the split of the investigator's patients, the effect on the choice The two groups will not control and interact
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz university of medical sciences
Street address
Glgasht-Tabriz university of medical science
City
Tabriz
Province
East Azarbaijan
Postal code
516746487
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.TBZmed.rec.1396.1289

Health conditions studied

1

Description of health condition studied
Idiopathic femoral head Osteonecrosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percentage of the Effect of shoe inserts on Pain Reduction and the Prevention of Clinical and Radiographic Progression in Patients with Idiopathic femoral head Osteonecrosis.
Timepoint
Every 3 month until one year
Method of measurement
With FICAT and HHS standard forms

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients prescribed for shoe inserts for them. Shoe inserts are used on both feet. shoe inserts are made of silicon and leather with a thickness of one centimeter in the heel area, which gradually decreases to Forefoot. Patients participating in the study are fully justified to use on a day to day basis. It should be noted that their exact presence during the study, in addition to accurate examination of the study, is also useful for the careful follow up of the disease and for the health of patients themselves.
Category
Treatment - Devices

2

Description
Control group: The control group will only take the usual medical treatment
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz-Shohada hospital
Full name of responsible person
Mahdi pashazadeh
Street address
Golshahr-elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5167846487
Phone
+98 41 3389 3221
Email
Dr.m.pashazadeh.85@gmail.com
Web page address
http://Shohadahosp.tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza sadeghpouur
Street address
Olshahr-elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5167846487
Phone
+98 41 3389 3221
Fax
+98 41 3389 3221
Email
Dr.m.pashazadeh.85@gmail.com
Web page address
http://Shohadahosp.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr mahdi pashazadeh
Position
Assistant of orthopedie
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Golshahr-elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5167846487
Phone
+98 41 3389 3221
Fax
+98 41 3389 3221
Email
Dr.m.pashazadeh.85@gmail.com
Web page address
http://shohadahosp.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Alireza Sadegpour
Position
Professor of orthopedic
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Golshahr-elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5167846487
Phone
+98 38 93221
Fax
+98 41 3389 3221
Email
Dr.m.pashazadeh.85@gmail.com
Web page address
http://shohadahosp.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr mahdi pashazadeh
Position
Assistant of orthopedi
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Golshar-elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5167846487
Phone
+98 41 3389 3221
Fax
+98 41 3389 3221
Email
Dr.m.pashazadeh.85@gmail.com
Web page address
http://Shohadahosp.tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of the obligation to hide patient information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The study will be published in the form of an article
When the data will become available and for how long
After thesis defense and publication of the article
To whom data/document is available
Everybody’s that journal allows
Under which criteria data/document could be used
Help to other researchers and patients
From where data/document is obtainable
The journal and researchers
What processes are involved for a request to access data/document
Journal editor and researchers
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