The goal of this study is assessment of effect of platelet rich plasma in clinical outcome and MRI findings in patients with knee osteoarthritis which is designed as a single blinded RCT. Osteoarthritis (OA) is a highly prevalent, chronic, degenerative condition that generates a high expense. Inclusion criteria are pain or joint swelling and radiologic findings of join destruction since 3 months ago based on knee osteoarthritis criteria of The ACR. exclusion criteria are pateints under treatment of anticoagulant or anti platelet drugs ,NSAIDs and corticosteroid usage and MRI contraindications and etc .this study is pilot and according to a same study sample size is 40 .patients will randomized in 2 groups and cases receive 2 intraarticular knee injections of PRP with 4 weeks interval.control group recieve only therapeutic exercise. before intervention and 6 months later,VAS and WOMAC questionnaires will be completed and cartilage lesion and signal change,bone marrow edema,synovitis and etc will be assessed by knee MRI with specific protocol and parameters. .
General information
Acronym
PRP:platelet rich plasma
IRCT registration information
IRCT registration number:IRCT2014020413442N6
Registration date:2014-02-26, 1392/12/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-26, 1392/12/07
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
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-05-31, 1392/03/10
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of platelet rich plasma intraarticular injection in clinical outcome and MRI findings in knee osteoarthritis
Public title
Assessment of platelet rich plasma injection in clinical outcome and MRI findings in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: arthralgia since past 3 months; radiologic evidence of articular damage (grade 1-4 of Kellgren-Lawrence scale) based on knee OA criteria of ACR. Exclusion criteria: systemic diseases such as diabetes mellitus and collagen vascular disorders; history or presence of cancer or malignant disorders; any infection and active wound of the knee; presence of immunosuppressive, autoimmune and platelet disorders; treatment with anticoagulant and anti-platelet medications 10 days before injection; use of NSAIDs 2 days before injection; history of knee articular injections of corticosteroids 3 weeks or use of systemic corticosteroids 2 weeks before PRP injections; hemoglobin measures of less than 12 g/dl and platelet counts of less than 150,000 per micro liter; recent history of severe trauma to the knee; age less than 45 or over 75 year; history of vasovagal shock; pregnancy; breastfeeding; genu valgum/varum greater than 20 degrees; contraindication for MRI including aneurysm clips,pacemaker,metallic devices and claustrophobia.
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Postal code
Approval date
2012-10-28, 1391/08/07
Ethics committee reference number
124
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
cartilage lesion
Timepoint
before intervention & 6 months after intervention
Method of measurement
WORMS criteria
2
Description
joint stiffness
Timepoint
before intervention & 6 months after intervention
Method of measurement
WOMAC questionnaire
3
Description
function
Timepoint
before intervention & 6 months after intervention
Method of measurement
WOMAC questionnaire
4
Description
knee pain
Timepoint
before intervention & 6 months after intervention
Method of measurement
WOMAC questionnaire
5
Description
knee pain
Timepoint
before intervention & 6 months after intervention
Method of measurement
VAS
6
Description
bone marrow edema
Timepoint
before intervention & 6 months after intervention
Method of measurement
WORMS criteria
7
Description
meniscus lesion
Timepoint
before intervention & 6 months after intervention
Method of measurement
WORMS criteria
8
Description
synovitis
Timepoint
before intervention & 6 months after intervention
Method of measurement
WORMS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : platelet rich plasma, knee intraarticular injection, 4 to 6 milliliter, 2 times, 4 weeks interval
Category
Treatment - Drugs
2
Description
Control group:exercise,quadriceps strengthening and hamstring stretching,10 times for 10 seconds,3 times a day
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Elham Ghorbani
Street address
Shahid Modarres Hospital, Kaj square, Saadat Abad street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Seyed Ahmad Raeissadat
Street address
Physical Medicine and Rehabilitation Department, Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid modarres hospital
Full name of responsible person
Elham Ghorbani
Position
Physical Medicine and Rehabilitation resident
Other areas of specialty/work
Street address
Shahid Modarres hospital, Kaj square, Saadat abad street
City
Tehran
Postal code
Phone
+98 21 2207 4090
Fax
Email
e_ghorbani@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Kaj square, Saadat Abad street
City
Tehran
Postal code
Phone
+98 21 2207 4090
Fax
Email
a_raeissadat@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)