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Protocol summary
Initially, the following items will be recorded for the patients who meet the inclusion criteria: Pain by VAS, Knee function by WOMAC, Knee function by KOOS, Flexion range of motion. After PRP preparation, patients will be referred to the Rehabilitation Department of the Shahid Madani Hospital. PRP injection will be given to patients supralaterally. The injection will be repeated twice with a 21 days apart. Then, the effect of PRP on patients will be evaluated in the intervals of 1, 3, 6 and 12 months after the first injection.
Initially, the following items will be recorded for the patients who meet the inclusion criteria: Pain by VAS, Knee function by WOMAC, Knee function by KOOS, Flexion range of motion. After PRP preparation, patients will be referred to the Rehabilitation Department of the Shahid Madani Hospital. PRP injection will be given to patients supralaterally. The injection will be repeated twice with a 21 days apart. Then, the effect of PRP on patients will be evaluated in the intervals of 1, 3 and 6 months after the first injection.
Initially, the following items will be recorded for the patients who meet the inclusion criteria: Pain by VAS, Knee function by WOMAC, Knee function by KOOS, Flexion range of motion. After PRP preparation, patients will be referred to the Rehabilitation Department of the Shahid Madani Hospital. PRP injection will be given to patients supralaterally. The injection will be repeated twice with a 21 days apart. Then, the effect of PRP on patients will be evaluated in the intervals of 1, 3, 6 and 126 months after the first injection.
در ابتدا موارد زیر برای این بیمارانی که دارای معیارهای ورود ذکر شده هستند، ثبت میشود: درد بوسیله VAS، عملکرد زانو به وسیله WOMAC، عملکرد زانو به وسیله KOOS، محدوده حرکتی زانو. پس از تهیه PRP، بیماران به بخش توانبخشی بیمارستان شهید مدنی ارجاع داده خواهند شد. تزریق PRP به بیماران به روش supralateral انجام خواهد شد. تزریق دوبار دیگر با فاصله 21 روز در میان تکرار میشود. سپس برای بررسی میزان تاثیر PRP بر بیماران در بازه های زمانی 1 و3 و6 و 12 ماه پس از اولین تزریق مواردی که قبلا ذکر شد ثبت خواهد شد.
در ابتدا موارد زیر برای این بیمارانی که دارای معیارهای ورود ذکر شده هستند، ثبت میشود: درد بوسیله VAS، عملکرد زانو به وسیله WOMAC، عملکرد زانو به وسیله KOOS، محدوده حرکتی زانو. پس از تهیه PRP، بیماران به بخش توانبخشی بیمارستان شهید مدنی ارجاع داده خواهند شد. تزریق PRP به بیماران به روش supralateral انجام خواهد شد. تزریق دوبار دیگر با فاصله 21 روز در میان تکرار میشود. سپس برای بررسی میزان تاثیر PRP بر بیماران در بازه های زمانی 1، 3 و 6 ماه پس از اولین تزریق مواردی که قبلا ذکر شد ثبت خواهد شد.
در ابتدا موارد زیر برای این بیمارانی که دارای معیارهای ورود ذکر شده هستند، ثبت میشود: درد بوسیله VAS، عملکرد زانو به وسیله WOMAC، عملکرد زانو به وسیله KOOS، محدوده حرکتی زانو. پس از تهیه PRP، بیماران به بخش توانبخشی بیمارستان شهید مدنی ارجاع داده خواهند شد. تزریق PRP به بیماران به روش supralateral انجام خواهد شد. تزریق دوبار دیگر با فاصله 21 روز در میان تکرار میشود. سپس برای بررسی میزان تاثیر PRP بر بیماران در بازه های زمانی 1 و3 و6، 3 و 126 ماه پس از اولین تزریق مواردی که قبلا ذکر شد ثبت خواهد شد.
Primary outcomes
#1
Before injection and 1, 3, 6 and 12 months after the first injection
Before injection and 1, 3 and 6 months after the first injection
Before injection and 1, 3, 6 and 126 months after the first injection
قبل از تزریق و 1 و3 و6 و 12 ماه پس از اولین تزریق
قبل از تزریق و 1، 3 و 6 ماه پس از اولین تزریق
قبل از تزریق و 1 و3 و6، 3 و 126 ماه پس از اولین تزریق
#2
Before injection and 1, 3, 6 and 12 months after the first injection
Before injection and 1, 3 and 6 months after the first injection
Before injection and 1, 3, 6 and 126 months after the first injection
قبل از تزریق و 1 و3 و6 و 12 ماه پس از اولین تزریق
قبل از تزریق و 1، 3 و 6 ماه پس از اولین تزریق
قبل از تزریق و 1 و3 و6، 3 و 126 ماه پس از اولین تزریق
#3
Before injection and 1, 3, 6 and 12 months after the first injection
Before injection and 1, 3 and 6 months after the first injection
Before injection and 1, 3, 6 and 126 months after the first injection
قبل از تزریق و 1 و3 و6 و 12 ماه پس از اولین تزریق
قبل از تزریق و 1، 3 و 6 ماه پس از اولین تزریق
قبل از تزریق و 1 و3 و6، 3 و 126 ماه پس از اولین تزریق
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Pishtaz teb zaman Co.
Name of organization / entity - Persian: شرکت پیشتاز طب زمان
Full name of responsible person - English: Behrooz Hajeian tehrani
Full name of responsible person - Persian: بهروز حاجیان تهرانی
Street address - English: Golha, Pishtaz teb zaman Co.
Street address - Persian: گلها. شرکت پیشتاز طب زمان
City - English: tehran
City - Persian: تهران
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 1494734463
Phone: +98 21 4219 7000
Fax:
Email: mehdi_yusefi@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Pishtaz Teb Zaman CO.
Name of organization / entity - Persian: شرکت پیشتاز طب زمان
Full name of responsible person - English: Behrooz Hajeian Tehrani
Full name of responsible person - Persian: بهروز حاجیان تهرانی
Street address - English: Golha, Pishtaz Teb Zaman CO.
Street address - Persian: گلها. شرکت پیشتاز طب زمان
City - English: Tehran
City - Persian: تهران
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 1494734463
Phone: +98 21 4219 7000
Fax:
Email: mehdi_yusefi@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Pishtaz teb zaman CoTeb Zaman CO. Name of organization / entity - Persian: شرکت پیشتاز طب زمان Full name of responsible person - English: Behrooz Hajeian tehraniTehrani Full name of responsible person - Persian: بهروز حاجیان تهرانی Street address - English: Golha, Pishtaz teb zaman CoTeb Zaman CO. Street address - Persian: گلها. شرکت پیشتاز طب زمان City - English: tehranTehran City - Persian: تهران Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 1494734463 Phone: +98 21 4219 7000 Fax: Email: mehdi_yusefi@yahoo.com Web page address:
Protocol summary
Study aim
The effects of PRP with reduced Leukocyte content therapy on chronic knee osteoarthritis
Design
This study is single-blind, phase 2 clinical trials on 15 patients based on inclusion and exclusion criteria, the study procedure will be explained to patients, and informed consent will be obtained before the study. One knee will be randomly selected for leukocyte-rich PRP injection and another knee will be injected using PRP with reduced Leukocyte content.
Settings and conduct
Initially, the following items will be recorded for the patients who meet the inclusion criteria: Pain by VAS, Knee function by WOMAC, Knee function by KOOS, Flexion range of motion. After PRP preparation, patients will be referred to the Rehabilitation Department of the Shahid Madani Hospital. PRP injection will be given to patients supralaterally. The injection will be repeated twice with a 21 days apart. Then, the effect of PRP on patients will be evaluated in the intervals of 1, 3 and 6 months after the first injection.
Participants/Inclusion and exclusion criteria
Radiologic findings with a period of three-month symptoms of knee osteoarthritis in both of knees. No history of knee surgery, blood disorders and confounders in the study results and no extraordinary deformation
Intervention groups
PRP with reduced Leukocyte content Treatment group,
Control group: treatment with Leukocyte-rich PRP.
Main outcome variables
1- Determining knee pain by VAS in all phases of clinical trial 2-Determination of knee function by WOMAC and KOOS in all phases of clinical trial 3-Determine the range of knee motion by manual joiniometry in all phases of the trial
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160422027520N14
Registration date:2019-08-24, 1398/06/02
Registration timing:registered_while_recruiting
Last update:2019-12-30, 1398/10/09
Update count:1
Registration date
2019-08-24, 1398/06/02
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of PRP with reduced Leukocyte content therapy on chronic knee osteoarthritis
Public title
Treatment of chronic knee osteoarthritis with PRP with reduced Leukocyte content
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between the ages of 18 and 75 with OA diagnosis based on the American College of Rheumatology
Analog scale of knee pain (VAS) equal to or greater than 2.5
People with at least 4 months of history of pain or swelling in one or both knees
Radiological classification scale Kellgren-Lawrence 1 or 2
The availability of individual during the study period
BMI Between 20 and 35
Exclusion criteria:
People under the age of 18 and over 75 years
Pregnant women or women who are breastfeeding
People with malignancy,People with severe heart disease, uncontrolled diabetes mellitus, rheumatoid arthritis, hemorrhagic diseases, history of anemia, arthritis, fibromyalgia and chronic fatigue syndrome
People with acetaminophen or vicodin addiction or a history of drug misuse
History of cortisone injections in the last 6 weeks
The use of non-steroidal anti-inflammatory drugs 1 week ago
Having hemoglobin less than 11 g / dl and platelet count less than 150000 / mμ
The use of inhibitors of platelet aggregation and anti-coagulation such as heparin
History of knee surgery in the last 3 months
Extraordinary deformation (varus >5ᵒ, valgus >5ᵒ)
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study participant will be unaware of his placement in the study group (PRP with reduced Leukocyte content or Leukocyte-Rich PRP ).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.TBZMED.REC.1398.472
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15.4
ICD-10 code description
Erosive (osteo)arthritis
Primary outcomes
1
Description
Determining knee pain
Timepoint
Before injection and 1, 3 and 6 months after the first injection
Method of measurement
Questionnaire (VAS)
2
Description
Determination of knee function
Timepoint
Before injection and 1, 3 and 6 months after the first injection
Method of measurement
Questionnaire (WOMAC), Questionnaire (KOOS)
3
Description
Determine the range of knee motion
Timepoint
Before injection and 1, 3 and 6 months after the first injection
Method of measurement
Manual joiniometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients, 10 ml of blood will be taken by PRP-specific syringe manufactured by Pishtaz Teb Zaman CO. and according to kit protocol, we will separate the PRP with reduced Leukocyte content. The PRP will then be injected by a physician into one of the two knees of the patient with knee osteoarthritis. The PRP injection volume will be 2 cc.The injection will be repeated twice with a 21 days apart.
Category
Treatment - Other
2
Description
Control group: Leukocyte-rich PRP will be Prepared and by the physician will be injected into another patient's knee. The PRP injection volume will be 2 cc. The injection will be repeated twice with a 21 days apart.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital, Tabriz
Full name of responsible person
Mehdi Yousefi, Ph.D Of Medical Immunology
Street address
Shahid Madani Hospital, Golbad Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7767
Email
mehdi_yusefi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pishtaz Teb Zaman CO.
Full name of responsible person
Behrooz Hajeian Tehrani
Street address
Golha, Pishtaz Teb Zaman CO.
City
Tehran
Province
East Azarbaijan
Postal code
1494734463
Phone
+98 21 4219 7000
Email
mehdi_yusefi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pishtaz Teb Zaman CO.
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
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