Protocol summary
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Study aim
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The effects of PRP with reduced Leukocyte content therapy on chronic knee osteoarthritis
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Design
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This study is single-blind, phase 2 clinical trials on 15 patients based on inclusion and exclusion criteria, the study procedure will be explained to patients, and informed consent will be obtained before the study. One knee will be randomly selected for leukocyte-rich PRP injection and another knee will be injected using PRP with reduced Leukocyte content.
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Settings and conduct
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Initially, the following items will be recorded for the patients who meet the inclusion criteria: Pain by VAS, Knee function by WOMAC, Knee function by KOOS, Flexion range of motion. After PRP preparation, patients will be referred to the Rehabilitation Department of the Shahid Madani Hospital. PRP injection will be given to patients supralaterally. The injection will be repeated twice with a 21 days apart. Then, the effect of PRP on patients will be evaluated in the intervals of 1, 3 and 6 months after the first injection.
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Participants/Inclusion and exclusion criteria
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Radiologic findings with a period of three-month symptoms of knee osteoarthritis in both of knees. No history of knee surgery, blood disorders and confounders in the study results and no extraordinary deformation
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Intervention groups
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PRP with reduced Leukocyte content Treatment group,
Control group: treatment with Leukocyte-rich 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 and KOOS in all phases of clinical trial 3-Determine the range of knee motion by manual joiniometry in all phases of the trial
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160422027520N14
Registration date:
2019-08-24, 1398/06/02
Registration timing:
registered_while_recruiting
Last update:
2019-12-30, 1398/10/09
Update count:
1
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Registration date
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2019-08-24, 1398/06/02
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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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2019-08-23, 1398/06/01
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Expected recruitment end date
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2020-03-19, 1398/12/29
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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 PRP with reduced Leukocyte content therapy on chronic knee osteoarthritis
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Public title
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Treatment of chronic knee osteoarthritis with PRP with reduced Leukocyte content
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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
People with acetaminophen or vicodin addiction 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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2
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Groups that have been masked
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Sample size
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Target sample size:
15
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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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Single blinded
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Blinding description
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The study participant will be unaware of his placement in the study group (PRP with reduced Leukocyte content or Leukocyte-Rich PRP ).
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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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2019-07-29, 1398/05/07
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Ethics committee reference number
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IR.TBZMED.REC.1398.472
Health conditions studied
1
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Description of health condition studied
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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
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Timepoint
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Before injection and 1, 3 and 6 months after the first injection
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Method of measurement
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Questionnaire (VAS)
2
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Description
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Determination of knee function
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Timepoint
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Before injection and 1, 3 and 6 months after the first injection
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Method of measurement
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Questionnaire (WOMAC), Questionnaire (KOOS)
3
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Description
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Determine the range of knee motion
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Timepoint
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Before injection and 1, 3 and 6 months after the first injection
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Method of measurement
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Manual joiniometry
Intervention groups
1
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Description
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Intervention group: In this group of patients, 10 ml of blood will be taken by PRP-specific syringe manufactured by Pishtaz Teb Zaman CO. and according to kit protocol, we will separate the PRP with reduced Leukocyte content. The PRP will then be injected by a physician into one of the two knees of the patient with knee osteoarthritis. The PRP injection volume will be 2 cc.The injection will be repeated twice with a 21 days apart.
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Category
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Treatment - Other
2
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Description
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Control group: Leukocyte-rich PRP will be Prepared and by the physician will be injected into another patient's knee. The PRP injection volume will be 2 cc. The injection will be repeated twice with a 21 days apart.
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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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Pishtaz Teb Zaman CO.
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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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Private
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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