Osteoarthritis is one of the most common joint disorders that is related by aging. It could decrease the quality of life. Most of the current treatments are palliative only and has no effect on the disease process. The goal of this study is to compare the efficacy and durability of treatment effect of autologe PRP with low weight hyaluronic acid on knee osteoarthritis. 76 patients, 49 in PRP group and 27 in Hyaloronic acid group will be follow in 2 and 6 months after injection using VAS and WOMAC index.
General information
Acronym
PRP: Plasma Rich Platelet
IRCT registration information
IRCT registration number:IRCT2015041121697N1
Registration date:2015-07-14, 1394/04/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-14, 1394/04/23
Registrant information
Name
Mohammad-Reza Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9936
Email address
m.sohrabi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, School of Medicine, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy and durability of treatment effect of autologe PRP with low weight hyaluronic acid on knee osteoarthritis
Public title
Effect of autologe PRP with hyaluronic acid on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic pain or swelling for at leas 4 months before radiological findings; degenerative changes in radiology
Exclusion criteria:
Systemic disorders like diabetes, rheumatoid arthritis; varus or valgus in spine more than 5 degree; hematologic disorders; chronic heart diseases; infections; immune compromise; hemoglobin less than 11; platelet less than 150000; incomplete questionnaire; incomplete treatment course; no interest to participate; multi-arthritis; intra-articular injection of hyaloronic acid in last 6 months; intra-articular injection of steroid in last 3 months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We allocate participants to two intervention groups by block random assignment. each block had 2 samples. We followed them for 6 months after intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Parvaneh St., Velenjak.
City
Tehran
Postal code
Approval date
2013-02-24, 1391/12/06
Ethics committee reference number
131
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Knee pain
Timepoint
0, 2 and 6 monts after injection
Method of measurement
WOMAC questionnaire
2
Description
Knee pain
Timepoint
0, 2 and 6 monts after injection
Method of measurement
VAS questionnaire
3
Description
Knee stiffnes
Timepoint
0, 2 and 6 monts after injection
Method of measurement
WOMAC questionnaire
4
Description
Knee function
Timepoint
0, 2 and 6 monts after injection
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
Septic arthritis
Timepoint
2 weeks after injection
Method of measurement
Inspection
Intervention groups
1
Description
Intervention group1:
Plasma rich platelet (PRP) done for only one knee, the worth on., Three injection by two weeks interval will be done. PRP is prepared by Blood transfusion organization kits. 10 patients were used to standardization of the Kit in two phases: first 15 Min with 1200/min and second 5 Min with 4000/min in room temperature.
Category
Treatment - Drugs
2
Description
Intervention group2: we use hyaloronic acid (trade mark: Hialgan, made in Germany) in this group. Three injection will be done by 1 week interval.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Dr. Zahra HajiHashemi
Street address
Makhsus St. Lashkar Cross
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, School of Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ali Ziaie
Street address
Parvaneh st., Velenjak
City
Tehran
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, School of Medicine, Shahid Beheshti University of Medical Sciences