Investigating the effect of PRGF on meniscal degeneration based on MRI findings
Design
A randomized controlled clinical trial with parallel groups, phase 3, on 52 patients. Random Allocation software will be used for randomization.
Settings and conduct
This randomized controlled clinical trial includes middle-aged patients with knee pain and evidence of meniscal degeneration on MRI. The knees are randomized to intervention and control group. The control group receives routine osteoarthritis treatment, and the intervention group receives two intra-articular injections of PRGF, one month apart, in addition to routine treatment. The patients’ symptoms are evaluated before the treatment and 4 months after the treatment using KOOS questionnaire. MRI is performed before the treatment and 4 months after the treatment to evaluate meniscal degeneration.
Participants/Inclusion and exclusion criteria
Inclusion criteria: (1) Individuals with knee pain; (2) Age between 40 and 60 years; (3) Meniscal degeneration detected on MRI. Exclusion criteria: (1) History of significant knee trauma; (2) Biomechanical abnormalities of the knee; (3) Meniscus or ligament tears; (4) History of rheumatic diseases; (5) History of septic arthritis of the knee; (6) Systemic diseases or medications that affect platelet count or function; (7) Malignancy or any severe systemic disease.
Intervention groups
In the control group, routine treatments for knee osteoarthritis include anti-inflammatory medication (500 mg of Naproxen every 12 hours), reducing knee strain through lifestyle changes, and strengthening the quadriceps muscle. In the intervention group, routine treatments plus two intra-articular injections of PRGF, which will be administered one month apart.
Main outcome variables
Grade of meniscal degeneration on MRI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210423051054N2
Registration date:2026-03-01, 1404/12/10
Registration timing:prospective
Last update:2026-03-01, 1404/12/10
Update count:0
Registration date
2026-03-01, 1404/12/10
Registrant information
Name
Rasa Salmani Oshnari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2223 1012
Email address
rasa_salmani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-06, 1404/12/15
Expected recruitment end date
2026-05-21, 1405/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Plasma Rich in Growth Factors on Meniscal Degeneration in Knee Osteoarthritis
Public title
The Effect of PRGF on Meniscal Degeneration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with knee pain
Age between 40 and 60 years
Meniscal degeneration detected on MRI
Exclusion criteria:
History of significant knee trauma
Biomechanical abnormalities of the knee
Meniscus or ligament tears
History of rheumatic diseases
History of septic arthritis of the knee
Systemic diseases or medications that affect platelet count or function.
Malignancy or any severe systemic disease
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial, 52 patients will be randomly enrolled in the study. Random Allocation software will be used to randomly allocate the samples. Using this software, random sequences will be created. For concealment, the random allocation concealment method will be used. In this method, the created sequences will be recorded on cards and these cards will be placed inside sealed envelopes. Then, based on the order in which the eligible individuals entered the study, each envelope will be opened and their assigned number will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman St, Shahid Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.849
Health conditions studied
1
Description of health condition studied
Meniscal degeneration
ICD-10 code
M23.3
ICD-10 code description
Other meniscus derangements
Primary outcomes
1
Description
Meniscal degeneration on MRI
Timepoint
Before treatment and 4 months after the start of treatment
Method of measurement
Magnetic Resonance Imaging
Secondary outcomes
1
Description
Pain, clinical symptoms, activities of daily living, function, and quality of life
Timepoint
Before treatment and 4 months after the start of treatment
Method of measurement
KOOS questionnaire
Intervention groups
1
Description
Control group: Routine treatments for knee osteoarthritis include anti-inflammatory medication (500 mg of Naproxen every 12 hours), reducing knee strain through lifestyle changes, and strengthening the quadriceps muscle.
Category
Treatment - Drugs
2
Description
Intervention group: Routine treatments plus two intra-articular injections of PRGF, which will be administered one month apart.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Najmeh Sadad Bolandnazar
Street address
Taleghani Hospital, Yaman St, Shahid Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
n.sadat.bolandnazar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman St, Shahid Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?