Protocol summary
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Study aim
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Effect of platelet lysate (PL) and platelet-rich plasma (PRP) on chronic knee osteoarthritis (OA)
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Design
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25 patients were selected based on radiologic findings with a period of 3 months symptoms of knee OA and PL was used for left knee and PRP was used for right knee . For the preparation of PL, 20 ml of blood from the upper cubital vein will be taken and, after production of PRP and, in order to produce PL, it is frozen at -80 ° C for 60 minutes, and then at 37°C Melt for 15 minutes. Then, centrifuge the platelets and WBC to remove the membranes and filter with 0.22 micrometers.
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Settings and conduct
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The following items for the patients who are most relevant, recorded:
1) Pain by visual analog scale (VAS)
2) Knee function by the WOMAC
3)The thickness of the knee cartilage using MRI
After PL and PRP quality control, patients will be referred to the Rehabilitation and Physical Medicine Department of the Shahid Madani Hospital for the injection of PL and PRP in the knee. An injection of PL and PRP into patients will be done by supralateral method, in which the patient will rest on the back and the knee will almost completely open. A second injection is repeated at intervals of 21 days. Then, in order to evaluate the effect of PL and PRP on patients in the intervals of 1and 6 months after the first injection, the cases mentioned above will be recorded.
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Participants/Inclusion and exclusion criteria
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A total of 25 patients were selected based on radiologic findings with a period of three-month symptoms of knee OA.
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Intervention groups
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Treatment of left knee with PL
Treatment of right knee with PRP
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Main outcome variables
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1- Determining knee pain by VAS in all phases of clinical trial
2-Determination of knee function by WOMAC in all phases of clinical trial
3-Determine the range of knee motion by manual joiniometry in all phases of the trial
4-Measuring Growth Factors in PL and PRP
General information
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Reason for update
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In this study, platelet-rich plasma was also used. The sample size was 25 people.1 and 6-month follow-up examination was performed. KOOS questionnaire removed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160422027520N10
Registration date:
2019-02-27, 1397/12/08
Registration timing:
registered_while_recruiting
Last update:
2021-02-08, 1399/11/20
Update count:
1
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Registration date
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2019-02-27, 1397/12/08
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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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2019-02-09, 1397/11/20
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Expected recruitment end date
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2019-12-21, 1398/09/30
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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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The effects of platelet lysate therapy and platelet-rich plasma on chronic knee osteoarthritis
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Public title
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Treatment of chronic knee osteoarthritis with platelet lysis and platelet-rich plasma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men and women between the ages of 18 and 75 with OA diagnosis based on the American College of Rheumatology
Analog scale of knee pain (VAS) equal to or greater than 2.5
People with at least 4 months of history of pain or swelling in one or both knees
Radiological classification scale Kellgren-Lawrence 1 or 2
The availability of individual during the study period
BMI Between 20 and 35
Exclusion criteria:
People under the age of 18 and over 75 years
Pregnant women or women who are breastfeeding
People with malignancy,People with severe heart disease, uncontrolled diabetes mellitus, rheumatoid arthritis, hemorrhagic diseases, history of anemia, arthritis, fibromyalgia and chronic fatigue syndrome
Those linked to acetaminophen or Vicodin or a history of drug misuse
History of cortisone injections in the last 6 weeks
The use of non-steroidal anti-inflammatory drugs 1 week ago
Having hemoglobin less than 11 g / dl and platelet count less than 150000 / mμ
The use of inhibitors of platelet aggregation and anti-coagulation such as heparin
History of knee surgery in the last 3 months
Extraordinary deformation (varus >5ᵒ, valgus >5ᵒ)
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
25
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2019-02-04, 1397/11/15
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Ethics committee reference number
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IR.TBZMED.REC.1397.923
Health conditions studied
1
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Description of health condition studied
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Knee Osteoarthritis
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ICD-10 code
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M15.4
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ICD-10 code description
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Erosive (osteo)arthritis
Primary outcomes
1
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Description
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Determining knee pain by VAS in all phases of clinical trial
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Timepoint
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1 and 6 months after the first injection
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Method of measurement
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Questionnaire (Visual Analogue Scale)
2
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Description
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Determination of knee function by Western Ontario and McMaster Universities Osteoarthritis Index in all phases of clinical trial
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Timepoint
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1 and 6 months after the first injection
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Method of measurement
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Questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
3
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Description
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Determine the range of knee motion by manual joiniometry in all phases of clinical trial
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Timepoint
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1 and 6 months after the first injection
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Method of measurement
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Range of motion (Degree)
4
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Description
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Measurement of growth factors in platelet lysate and Platelet-rich plasma
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Timepoint
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1 and 6 months after the first injection
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Method of measurement
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Elisa
Secondary outcomes
1
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Description
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Determine the thickness of the knee cartilage
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Timepoint
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6 months after the first injection
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Method of measurement
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MRI
Intervention groups
1
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Description
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Intervention group: Patients with knee arthritis receiving platelet lysate and platelet-rich plasma
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Category
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Treatment - Other
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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Tabriz 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