Efficacy of intra-articular injection of a newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid on pain and function of patients with knee osteoarthritis: A single-blinded randomized clinical trial
Objectives: The aim of this study is to compare efficacy and safety of intra articular injection of newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid patients with knee OA.
Design
Study Design: Single blind Randomized clinical trial.
Settings and conduct
Setting and Conduct: In this study a total of 60 patients with more than three months of chronic pain in the knee joints along with consistent imaging findings (Kellgren-Lawrence score of Ⅱ&Ⅲ) would be enrolled and randomly allocated into two groups of plasma rich in growth factors (PRGF) versus hyaluronic acid.
Participants/Inclusion and exclusion criteria
Participants: Patients suffering from mild to moderate knee OA refered to Shahid Modarres Hospital of Saadat Abad in Tehran in 2016.
Intervention groups
Interventions: A single injection of plasma rich in growth factors (PRGF) in one group and a hyaluronic acid in other group.
Main outcome variables
Outcome measuers: Patients would be evaluated at baseline and 8, 24 weeks & 12 months after injection for pain, stiffness and function using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130523013442N23
Registration date:2018-03-24, 1397/01/04
Registration timing:registered_while_recruiting
Last update:2018-03-24, 1397/01/04
Update count:0
Registration date
2018-03-24, 1397/01/04
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intra-articular injection of a newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid on pain and function of patients with knee osteoarthritis: A single-blinded randomized clinical trial
Public title
Efficacy of intra-articular injection of a newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid on pain and function of patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45-75 years
Symptomatic knee OA with the pain aggravated by weight bearing
Symptoms lasting for at least 6 months despite conservative treatment
Kellgren-Lawrance radiology scoring system scores ranging from 2-3
Exclusion criteria:
History of trauma , surgery or any invasive procedure in the affected joint during the past 6 months
Mal-alignment in lower limbs and abnormal blood count or impared coagulation test
Pregnant women
Patients who were under immunosuppressant treatments
Those with an underlying systemic arthropathy (secondary OA)
Patients been treated with angiotensin converting enzyme inhibitors (ACE I) and significant deficiency in glucose 6 - phosphate dehydrogenase (G6PD) level
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study a total of 60 patients with more than three months of chronic pain in the knee joints along with consistent imaging findings (Kellgren-Lawrence score of Ⅱ&Ⅲ) would be enrolled and randomly allocated into two groups of plasma rich in growth factors (PRGF) versus hyaluronic acid
Blinding (investigator's opinion)
Single blinded
Blinding description
Random table number is used to randomize. This is a single blind study and patients are not aware of the type of injected drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Sahahid Arabi street, Yaman street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.SBMU.MSP.REC.1396.645
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
Knee Pain
Timepoint
Before intervention, 6 months & 12months after intervention
Method of measurement
Change of WOMAC questionnaire scores
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: plasma rich in growth factor, knee intraarticular injection, 4 to 6 milliliter, 2 times, 3 weeks interval
Category
Treatment - Drugs
2
Description
Intervention group 2 : Hyaluronic acid (500,000 to 730000 Daltons),3times, weekly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Saadat Abad St.
City
Tehran
Province
Tehran
Postal code
1998734383
Email
a_raeissadat@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Modarres Hospital, Kaj Square, Saadat Abad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1998734383
Email
a_raeissadat@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Physical Medicine and Rehabilitation Department, Shahid Beheshti University of Medical Sciences, Sch
Full name of responsible person
Pegah Yavari
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres hospital, Kaj square, Saadat abad street
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2200 8941
Email
yavari@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor of Physical Medicine and Rehabilitation departmen, Shahid Beheshti University of