Protocol summary

Study aim
A comparative study of the effects of platelet-rich plasma and platelet-rich fibrin and methylprednisolone injections in the treatment of grade 1 - 3 knee osteoarthritis
Design
Clinical trial, with parallel groups, blinded, randomized ,phase 3 on 60 patients
Settings and conduct
Imam Khomeini hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Grade I, II, and III osteoarthritis of the knee, at least have used one of the two methods of osteoarthritis treatment, such as taking acetaminophen and NSAIDs, aids, lifestyle changes, weight reduction and not achieved the desired result. At least two weeks have passed since the last use of NSAID or corticosteroid. Exclusion criteria: Breastfeeding or pregnancy, suffering from rheumatoid disease, severe heart disease, skin infection at the injection site, taking immunosuppressive drugs, receiving anticoagulants, history of hemorrhagic disease or history of coagulation disorders or anemia, current back pain radiating to the lower limbs, history of knee surgery in the past 3 months, infection or active malignancy in the past 6 months, drug abuse, intra-articular injection of corticosteroids in the past 2 months or hyaluronic acid in the past 6 months
Intervention groups
60 patients are studied. AP & lateral radiological image of the of the knee is taken in a standing position. Patients are randomly divided into three groups of 20. In the first group, the treatment is performed with a single injection of platelet-rich plasma. In the second group, one injection of platelet-rich fibrin is performed. In the third group, one injection of 1 cc of methylprednisolone is performed. all injections are performed as knee intra articular .Patients are evaluated once before and then 1 and 3 and 6 months after the injection.
Main outcome variables
Pain . Improve daily performance .stiffness of knee joint

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240223061090N1
Registration date: 2024-07-14, 1403/04/24
Registration timing: registered_while_recruiting

Last update: 2024-07-14, 1403/04/24
Update count: 0
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
Shiva Mohammadalizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6657 2608
Email address
shiva.alizadeh.samani@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of platelet-rich plasma, platelet-rich fibrin and methylprednisolone injections in the treatment of knee arthrosis.
Public title
comparison of the effects of platelet-rich plasma, platelet-rich fibrin and methylprednisolone injections in the treatment of knee arthrosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients based on ACR (American college of rheumatology) radiological criteria with knee Grade I, II and III osteoarthritis
Exclusion criteria:
Patients who are breastfeeding or pregnant They have rheumatoid arthritis or severe heart disease. Have a skin infection at the injection site Be a consumer of immunosuppressive drugs or anticoagulants such as warfarin and heparin A history of bleeding or a description of clotting disorders or anemia Have current back pain with spreading to lower limbs Have a history of knee surgery in the last three months Have an active infection or malignancy within the previous 6 months Substance abuse Intra-articular corticosteroid injections in the last 2 months or hyaluronic acid in the last 6 months
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block randomization، Randomization unit: individual Based on number blocking by Excel software
Blinding (investigator's opinion)
Single blinded
Blinding description
For blinding, PRP, PRF and methyl prednisolone syringes are prepared in similar shapes and are coated by coating, and each syringe is given a code, and each patient is given a code, and only the researcher knows which syringe will be injected into which patient at what time . The group that is injected with methyl prednisolone also takes 5 cc of venous blood similar to other groups and is sent to the laboratory for CBC testing to observe ethical issues.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Mahdi hospital. The intersection of Bagherkhan . Next to the Chamran Highway Street.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.170

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
A comparative study of the effects of platelet-rich plasma, platelet-rich fibrin and prednisolone injections in the treatment of knee arthrosis.
Timepoint
Evaluation of patients before intervention begins and 1, 3 and 6 months after injection
Method of measurement
Vas criteria, WOMAC questionnaire

Secondary outcomes

1

Description
Comparative study of the effects of platelet-rich plasma injections and platelet-rich fibrin and prednisolone on reducing pain in knee osteoarthritis
Timepoint
Before the start of the intervention and then 1, 3 and 6 months after the injection
Method of measurement
VAS criteria. WOMAC questionnaire

2

Description
Comparative study of the effects of platelet-rich plasma injections and platelet-rich fibrin and prednisolone on reducing stiffness in knee osteoarthritis
Timepoint
Before the start of the intervention and then 1, 3 and 6 months after the injection
Method of measurement
WOMAC questionnaire

3

Description
Comparative study of the effects of platelet-rich plasma injections and platelet-rich fibrin and prednisolone on daily functioning of patients with knee osteoarthritis
Timepoint
Before the start of the intervention and then 1, 3 and 6 months after the injection
Method of measurement
WOMAC questionnaire

Intervention groups

1

Description
First intervention group: in the first group, treatment is done with a platelet-rich plasma injection, so that 20 CC of blood is taken from the patient and centrifuged in the first round at MPR1800 for 15 minutes, and in the second round at MPR1800 per minute for 12 minutes, and finally 4 CC is drawn in the syringe for injection in the knee.
Category
Treatment - Other

2

Description
Second intervention group: in the second group, a platelet-rich fibrin injection is performed. To do this 10 cc of blood is taken from the patient and centrifuged at a distance of 2700MPR per minute for 4 minutes and then the top fluid is drawn with a syringe and used for injection
Category
Treatment - Other

3

Description
Third intervention group: in the third group, a1 CC cortisone injection (methyl prednisolone) is performed in the knee.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
imam khomeini hospital
Full name of responsible person
Shiva Mohammad Alizadeh
Street address
End of Keshavarz Boulevard. Next to the Chamran Highway.
City
Tehran
Province
Tehran
Postal code
14197 33141
Phone
+98 21 6119 0000
Email
Shiva.alizadeh.samani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali akbar Sari
Street address
Pursina street, Enghlab street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Email
Shiva.alizadeh.samani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shiva Mohammad alizadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Next to the Chmaran Highway.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 901 076 8913
Email
Shiva.alizadeh.samani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Hosseini
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Next to the Chamran highway
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 912 265 1173
Email
m_hosseini۱۰۰@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shiva mohammad alizadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
next to the Chamran highway
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 901 076 8913
Email
shiva.alizadeh.samani@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
Loading...