Protocol summary
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Study aim
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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
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Design
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single blind randomised clinical trial without control group, three groups of 20 parallel interventions
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Settings and conduct
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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 .
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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effect on pain ؛ joint stiffness ؛ pateint's function ؛ activity of daily living
General information
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Reason for update
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Unfortunately, the expected recruitment end date was filled 26/09/2019 instead of 26/09/2020.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130523013442N30
Registration date:
2019-11-29, 1398/09/08
Registration timing:
registered_while_recruiting
Last update:
2022-05-19, 1401/02/29
Update count:
1
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Registration date
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2019-11-29, 1398/09/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-06-04, 1398/03/14
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Expected recruitment end date
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2020-09-26, 1399/07/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Random table number is used to randomize. This is a single blind study and patients are not aware of the type of injected drug.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-05-04, 1398/02/14
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Ethics committee reference number
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IR.SBMU.MSP.REC.1398.052
Health conditions studied
1
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Description of health condition studied
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hip osteoarthritis
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ICD-10 code
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M16
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ICD-10 code description
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Osteoarthritis of hip
Primary outcomes
1
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Description
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hip pain
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Timepoint
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before intervention,2 months & 6months after intervention
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Method of measurement
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changes of WOMAC and VAS and LEQUESNE questionnaires scores
2
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Description
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joint stiffness
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Timepoint
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before intervention,2 months & 6 months after intervention
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Method of measurement
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change of WOMAC questionnaire scores
3
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Description
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function
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Timepoint
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before intervention,2 months & 6 months after intervention
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Method of measurement
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change of WOMAC questionnaire scores
4
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Description
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activity of daily living
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Timepoint
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before intervention,2 months & 6 months after intervention
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Method of measurement
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change of LEQUESNE questionnaire scores
Intervention groups
1
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Description
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Intervention group: platelet rich plasma , hip intraarticular injection, 4 to 6 milliliter, 2 times, 2 weeks interval
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Hyaluronic acid (molecular weight more than 3000 kilo Daltons),2times, 2 weeks interval
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Hyaluronic acid (molecular weight more than 3000 kilo Daltons) and platelet rich plasma , hip intraarticular injection,2times, 2 weeks interval
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available