Reducing costs - preserving the health of patients - using a low-complication alternative method for the complicated operation of replacing the femoral head in children with avascular necrosis of the femoral head
Design
Clinical trial without control group, phase 3 on 32 patients.
Settings and conduct
Patients under 18 years of age who refer to the pain clinic in Firouzgar- Hazrat Rasool (PBUH) training center with a diagnosis of Avascular necrosis of femoral head who do not want to undergo surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1- no underlying diseases or mild disease under control (ASA1,2) of both sexes with a diagnosis of Avascular necrosis of femoral head grade 4-6 (according to the diagnostic criteria of Massachusetts Hospital 2) including 16 patients with unilateral diagnosis This complication and 16 patients with bilateral diagnosis of this complication 2- Age range 8-15 years 3- Weight within normal range (BMI for men in the range of 22-26 and women in the range of 22-24) 4- Non-agreement to joint replacement surgery; Exclusion criteria include: 1- patient's lack of consent to participate or continue the plan 2- history of cancer 3- sensitivity to laser light
Intervention groups
In this study, separate Red, IR laser through the skin on the anatomical site of the affected hip joint with a determined dose during 6 periods of 16 sessions in total 96 sessions with an amount of 30 joules from the two mentioned lasers for 12 points for each joint in each session - during It is irradiated for 15 months. It should be noted that for patients with bilateral complications, this procedure is performed for the other affected joint with the same method. The treatment course is done for each patient
Main outcome variables
Reducing inflammation - tissue regeneration and revascularization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N41
Registration date:2022-11-02, 1401/08/11
Registration timing:prospective
Last update:2022-11-02, 1401/08/11
Update count:0
Registration date
2022-11-02, 1401/08/11
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of local low power laser in the treatment of avascular necrosis of Pediatric’s femoral head
Public title
Investigating the effect of low-power laser in the treatment of necrosis of the femoral head, a debilitating disease in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No underlying diseases or mild disease under control (ASA1,2) of both genders with a diagnosis of Avascular necrosis of femoral head grade 4-6 (according to the diagnostic criteria of Massachusetts Hospital
Age range 8-15
Weight in the normal range (BMI for men in the range of 22-26 and for women in the range of 22-24)
disagree to hip replacement surgery
Exclusion criteria:
Failure of the patient to agree to participate or continue the plan
History of cancer
Sensitivity to laser light
Age
From 8 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Organizational committee of ethics in biomedical research of research assistant
Reducing inflammation - tissue regeneration and revascularization
Timepoint
Red, IR laser separately through the skin on the anatomical site of the affected hip joint with a determined dose during 6 periods of 16 sessions (each period is two months and a ten-day break between each period) (a total of 96 sessions with an amount of 30 joules from the two mentioned lasers) irradiated for 12 points for each joint in each session - during 15 months
Method of measurement
Clinical criteria - MRI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of Red, IR laser for patients
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
To the pain clinic in Firouzgar - Hazrat Rasool (PBUH) training center
Full name of responsible person
Ali Akbar Jafarian
Street address
Hazrat Rasool medical center, Mazyar Mansouri st,Starkhan Ave.ttar Khan
City
Tehran
Province
Tehran
Postal code
14456 13131
Phone
+98 21 6435 1000
Email
aajafari41@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
َAfshin Zarghi, Vice-Chancellor of Research Affairs
Street address
Shahid Beheshti University of medical sciences, Yaman st, Daneshjoo Blvd
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2271 8021
Email
laser.cntr@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
ali akbar jafarian
Position
Assistant Professor of Shahid Beheshti University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shohada Tajrish Hospital, Shahrdary st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
aajafari41@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
ali akbar jafarian
Position
Assistant Professor of Shahid Beheshti University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shohada Tajrish Hospital, Shahrdary st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
aajafari41@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
ali akbar jafarian
Position
Assistant Professor of Iran University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasool medical center, Mazyar Mansouri street,Satarkhan Ave,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
aajafari41@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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