A comparative study of the effectiveness of prp and prf injections under ultrasound guidance in improving the symptoms and performance of patients with Osteoarthritis (Grade 2 and 3 according to the Kellgren-Lawrence classification)
comparative study of the effectiveness of prp and prf injections under ultrasound guidance in improving the symptoms and performance of patients with Osteoarthritis
Design
A controlled clinical trial with parallel groups, double-blind, randomized, phase 2 on 56 patients (28 in each group). The rand function of Excel software was used for randomization.
Settings and conduct
This clinical trial study will be conducted in 1404 AH in patients with knee osteoarthritis at Imam Khomeini Hospital, Tehran. Patient information including demographic information (age, gender, underlying disease, height and weight), knee function status will be collected and recorded. Then, patients will be randomly divided into two groups, one group will receive PRP and the other group will receive PRF injection under ultrasound guidance. All measurements will be taken in all patients in both groups before the intervention and at weeks 1, 4 and 12 after the intervention. The people who collected the software and performed the analysis will be blinded.
Participants/Inclusion and exclusion criteria
Patients aged 50 to 75 years who have knee OA grade 2 and 3 according to the Kellgren-Lawrence classification
Intervention groups
Patients aged 50 to 75 years who have knee OA grade 2 and 3i injection of PRP and PR according to the Kellgren-Lawrence classification
PRP was injected into one group and PRF was injected into the other group.
Main outcome variables
Quality of life and knee range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190719044274N2
Registration date:2026-06-15, 1405/03/25
Registration timing:registered_while_recruiting
Last update:2026-06-15, 1405/03/25
Update count:0
Registration date
2026-06-15, 1405/03/25
Registrant information
Name
Shervin Shahinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 7624
Email address
sshahinpour@student.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-06-02, 1404/03/12
Expected recruitment end date
2026-09-11, 1405/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of prp and prf injections under ultrasound guidance in improving the symptoms and performance of patients with Osteoarthritis (Grade 2 and 3 according to the Kellgren-Lawrence classification)
Public title
A comparative study of the effectiveness of prp and prf injections under ultrasound guidance in improving the symptoms and performance of patients with Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 50 to 75 years who have.
Patients with knee osteoarthritis grade 2 and 3 according to the Kellgren-Lawrence classification
Exclusion criteria:
Exclusion criteria included systemic disease such as diabetes, immunodeficiency, collagen vascular disease, history of malignancy, active infection or wound in the knee, autoimmune diseases, disorders affecting platelets.
Hemoglobin < 12 mg/dL or platelets < 150,000/microL, history of severe knee trauma
Steroid injection in the knee 3 weeks before surgery, systemic steroid injection in the last 2 weeks
Hemoglobin < 12 mg/dL or platelets < 150,000/microL, history of severe knee trauma
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The random block model is a generative model for random networks.
Randomization unit: individual
Randomization layers if stratified randomization is used
Randomization tool: such as a random number table
Blinding (investigator's opinion)
Triple blinded
Blinding description
The randomized block model is a generative model for two-group random networks.
Randomization unit: individual
Randomization tool: such as a random number table
With the help of computers, random number tables are prepared. These tables have different names and types. These tables are actually rows and columns of numbers that are randomly determined by the computer.
In double-blind studies, not only the participant is unaware of their placement in the intervention and control groups; the follow-up and analyst are also unaware of it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Imam Khomeini Hospital, Tehran University of Medical Scienc
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2026-02-24, 1404/12/05
Ethics committee reference number
IR.TUMS.IKHC.REC.1404.503
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
Improve knee mobility
Timepoint
2 weeks
Method of measurement
Numeric rating scale questionnaire
Secondary outcomes
1
Description
Range of motion
Timepoint
6 w
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Platelet-rich fibrin belongs to a new generation of hemoconcentrates obtained by centrifugation alone, which provide. GF does not require additives such as heparin or thrombin and allows for slow release. GF has the following bioactive properties: stimulation by PRF, in addition to proliferation, differentiation, chemotaxis and adhesion of stem cells, promotion of vascularization and immune processes, increased expression of alkaline phosphatase in stem cells, which leads to faster mineralization of newly formed tissue. It also contains transforming growth factor beta GF. It also causes direct mineralization and creates an epithelial barrier by the membrane (PDGF) and platelet-derived growth factor (TGF-β1). 15 PRF
Category
Treatment - Other
2
Description
Control group: PRP intra-knee injection PRP preparation method: To prepare PRP, 10 ml of venous blood sample will be taken by centrifugation at 3400 rpm for 15 minutes at room temperature using a Neuation swing rotor centrifuge and 3.5 ml of PRP will be produced. The test tubes will contain sodium citrate solution as an anticoagulant and autologous thrombin as an activator to promote platelet activation and conversion of fibrinogen to fibrin. For quality tests, 0.5 ml of the PRP sample will be sent to the laboratory and 3 ml will be used for ultrasound-guided injection.