Effect of ultrasound guided intra articular injection of platelet rich plasma(PRP), hyaluronic acid(HA) and combined PRP and HA in patients with hip osteoarthritis
the comparison between effect of platelet rich plasma(PRP), hyaluronic acid(HA) and combined PRP and HA intra articular injection on pain , stiffness and activity of daily living of patients with hip osteoarthritis
Design
single blind randomised clinical trial without control group, three groups of 20 parallel interventions
Settings and conduct
A randomized, single blind clinical trial was done on 60 patients with mild to moderate hip osteoarthitis referred to the educational center of Modarres Hospital in Tehran. Patients were randomly divided into three groups: Hyaluronic Acid and PRP and combination of these two .
Participants/Inclusion and exclusion criteria
Patients with hip osteoarthritis based on American College of Rheumatology criteria at the age of 70-40 years and with the duration of symptoms more than three months that are recognized by hip x-ray (Grade 2 and 3)
1-systemic diseases such as diabetes mellitus,collagen vascular disorders 2-history of malignancy 3-hip infection or active wound 4-autoimmune disorders or coagulopathy 5-history of NSAID use 2 days before injection 6-Patients who were under anticoagulant or anti platele treatments 7-hemoglobin < 12 and plt < 150000 8- history of severe hip trauma 9- age less than 40 and more than 70 10- history of vasovagal shock 11- pregnancy and breastfeeding 12- allergy to protein of egg , feather or hypersensitivity to hyaluronate
Intervention groups
Intervention group 1: platelet rich plasma, Hip intraarticular injection, 4 to 6 milliliter, 2 times ,2 weeks interval
Intervention group 2 : Hyaluronic acid (Over 3000 KiloDaltons),2 times ,2 weeks interval
Intervention group 3: Combiation of platelet rich plasma and Hyaluronic acid ,2 times ,2 weeks interval
Main outcome variables
effect on pain ؛ joint stiffness ؛ pateint's function ؛ activity of daily living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130523013442N30
Registration date:2019-11-29, 1398/09/08
Registration timing:retrospective
Last update:2019-11-29, 1398/09/08
Update count:1
Registration date
2019-11-29, 1398/09/08
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
2019-06-04, 1398/03/14
Expected recruitment end date
2019-09-26, 1398/07/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ultrasound guided intra articular injection of platelet rich plasma(PRP), hyaluronic acid(HA) and combined PRP and HA in patients with hip osteoarthritis
Public title
Effect of ultrasound guided intra articular injection of platelet rich plasma(PRP), hyaluronic acid(HA) and combined PRP and HA in patients with hip osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hip osteoarthritis based on American College of Rheumatology criteria at the age of 70-40 years and with the duration of symptoms more than three months that are recognized by hip x-ray (Grade 2 and 3)
at the age of 70-40 years
duration of symptoms more than three months
Grade 2 and 3 recognized by hip x-ray
Exclusion criteria:
Systemic diseases such as diabetes mellitus,collagen vascular disorders or immune deficiency
History of malignancy
Hip infection or active wound
History of NSAIDs usage within 2 days before injection
Patients who were under anticoagulant or antiplatelet treatments within 10 days before injection
Hemoglobin < 12 and plt < 150000
History of severe hip trauma
Pregnancy and breastfeeding
Allergy to protein of egg , feather or hypersensitivity to hyaluronate
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
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 hip joints along with consistent imaging findings would be enrolled and randomly allocated into three groups of platelet rich plasma versus hyaluronic acid and the combination of these two.
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
Ethics committee of Shahid Beheshti University of Medical Sciences
before intervention,2 months & 6months after intervention
Method of measurement
changes of WOMAC and VAS and LEQUESNE questionnaires scores
2
Description
joint stiffness
Timepoint
before intervention,2 months & 6 months after intervention
Method of measurement
change of WOMAC questionnaire scores
3
Description
function
Timepoint
before intervention,2 months & 6 months after intervention
Method of measurement
change of WOMAC questionnaire scores
4
Description
activity of daily living
Timepoint
before intervention,2 months & 6 months after intervention
Method of measurement
change of LEQUESNE questionnaire scores
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: platelet rich plasma , hip intraarticular injection, 4 to 6 milliliter, 2 times, 2 weeks interval
Category
Treatment - Drugs
2
Description
Intervention group: Hyaluronic acid (molecular weight more than 3000 kilo Daltons),2times, 2 weeks interval
Category
Treatment - Drugs
3
Description
Intervention group: Hyaluronic acid (molecular weight more than 3000 kilo Daltons) and platelet rich plasma , hip intraarticular injection,2times, 2 weeks interval
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
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Tehran, Saadat Abad, Kaj Square, Shahid Modarres Hospital
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Shahid Modarres Hospital
Full name of responsible person
Parya Peydayesh
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Saadat Abad St.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
paryapey@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor of Physical Medicine and Rehabilitation departmen, Shahid Beheshti University of