Comparison of Platelet Rich Plasma and Hyaluronic acid intraarticular injection on clinical outcome and Quality of life of patients with knee osteoarthritis
The goal of this study is comparison of effect of intaraarticular injection of platelet rich plasma and hyaluronic acid in function and quality of life in patients with knee osteoarthritis .Osteoarthritis is a prevalent condition that generates a high expense. patients with pain or joint swelling and radiologic findings of join destruction since 3 months ago based on knee osteoarthritis criteria of The ACR will recruited. exclusion criteria are patients under treatment of anticoagulant or anti platelet drugs ,NSAIDs and corticosteroid usage and etc. 160 patients with knee OA will randomized in 2 groups and received PRP or HA injection. Two injection of PRP will be recieved with 4 weeks interval and HA will injected 3 time with 1 week interval.exercise will be prescribed for 2 groups. pain, function and quality of life will measured through SF36 and WOMAC questionnaires before intervention and after 12 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012113442N5
Registration date:2014-02-03, 1392/11/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-03, 1392/11/14
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
2012-10-31, 1391/08/10
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Platelet Rich Plasma and Hyaluronic acid intraarticular injection on clinical outcome and Quality of life of patients with knee osteoarthritis
Public title
cCmparison of Platelet Rich Plasma and Hyaluronic acid in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: arthralgia since the 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.
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethic committee of Shahid beheshti University of Medical sciences
Street address
Shahid beheshti University of Medical sciences,Velenjak
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
quality of life
Timepoint
before intervention & 1 year after intervention
Method of measurement
SF-36 questioner
2
Description
function
Timepoint
before intervention & 1 year after intervention
Method of measurement
WOMAC questioner
3
Description
knee pain
Timepoint
before intervention & 1 year after intervention
Method of measurement
WOMAC questioner
4
Description
joint stiffness
Timepoint
before intervention & 1 year after intervention
Method of measurement
WOMAC questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: platelet rich plasma, knee intraarticular injection, 4 to 6 milliliter, 2 times, 4 weeks interval