<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190719044274N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>A comparative study of the effectiveness of prp and prf injections under ultrasound guidance in improving the symptoms and performance of patients with Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effectiveness of prp and prf injections under ultrasound guidance in improving the symptoms and performance of patients with Osteoarthritis (Grade 2 and 3 according to the Kellgren-Lawrence classification)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/89386</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random block model is a generative model for random networks.
Randomization unit: individual
Randomization layers if stratified randomization is used
Randomization tool: such as a random number table, Blinding description: The randomized block model is a generative model for two-group random networks.
Randomization unit: individual

Randomization tool: such as a random number table
With the help of computers, random number tables are prepared. These tables have different names and types. These tables are actually rows and columns of numbers that are randomly determined by the computer.

In double-blind studies, not only the participant is unaware of their placement in the intervention and control groups; the follow-up and analyst are also unaware of it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Platelet-rich fibrin belongs to a new generation of hemoconcentrates obtained by centrifugation alone, which provide. GF does not require additives such as heparin or thrombin and allows for slow release. GF has the following bioactive properties: stimulation by PRF, in addition to proliferation, differentiation, chemotaxis and adhesion of stem cells, promotion of vascularization and immune processes, increased expression of alkaline phosphatase in stem cells, which leads to faster mineralization of newly formed tissue. It also contains transforming growth factor beta GF. It also causes direct mineralization and creates an epithelial barrier by the membrane (PDGF) and platelet-derived growth factor (TGF-β1). 15 PRF. Intervention 2: Control group: PRP intra-knee injection PRP preparation method: To prepare PRP, 10 ml of venous blood sample will be taken by centrifugation at 3400 rpm for 15 minutes at room temperature using a Neuation swing rotor centrifuge and 3.5 ml of PRP will be produced. The test tubes will contain sodium citrate solution as an anticoagulant and autologous thrombin as an activator to promote platelet activation and conversion of fibrinogen to fibrin. For quality tests, 0.5 ml of the PRP sample will be sent to the laboratory and 3 ml will be used for ultrasound-guided injection.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is In the case of individual participant data (IPD) there is no plan to share the data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Espahbodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavaraz Blvd, Gharib Ave, Imam khomeini hospital,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416753955</zip>
        <telephone>+98 21 6119 0000</telephone>
        <email>Shervinshahinpour@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Espahbodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavaraz Blvd, Gharib Ave, Imam khomeini hospitalTehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416753955</zip>
        <telephone>+98 21 6119 0000</telephone>
        <email>Shervinshahinpour@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 50 to 75 years who have.
Patients with knee osteoarthritis grade 2 and 3 according to the Kellgren-Lawrence classification</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria included systemic disease such as diabetes, immunodeficiency, collagen vascular disease, history of malignancy, active infection or wound in the knee, autoimmune diseases, disorders affecting platelets.
Hemoglobin &lt; 12 mg/dL or platelets &lt; 150,000/microL, history of severe knee trauma
Steroid injection in the knee 3 weeks before surgery, systemic steroid injection in the last 2 weeks
Hemoglobin &lt; 12 mg/dL or platelets &lt; 150,000/microL, history of severe knee trauma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Platelet-rich fibrin belongs to a new generation of hemoconcentrates obtained by centrifugation alone, which provide. GF does not require additives such as heparin or thrombin and allows for slow release. GF has the following bioactive properties: stimulation by PRF, in addition to proliferation, differentiation, chemotaxis and adhesion of stem cells, promotion of vascularization and immune processes, increased expression of alkaline phosphatase in stem cells, which leads to faster mineralization of newly formed tissue. It also contains transforming growth factor beta GF. It also causes direct mineralization and creates an epithelial barrier by the membrane (PDGF) and platelet-derived growth factor (TGF-β1). 15 PRF</i_keyword>
      <i_keyword>Control group: PRP intra-knee injection PRP preparation method: To prepare PRP, 10 ml of venous blood sample will be taken by centrifugation at 3400 rpm for 15 minutes at room temperature using a Neuation swing rotor centrifuge and 3.5 ml of PRP will be produced. The test tubes will contain sodium citrate solution as an anticoagulant and autologous thrombin as an activator to promote platelet activation and conversion of fibrinogen to fibrin. For quality tests, 0.5 ml of the PRP sample will be sent to the laboratory and 3 ml will be used for ultrasound-guided injection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve knee mobility. Timepoint: 2 weeks. Method of measurement: Numeric rating scale questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion. Timepoint: 6 w. Method of measurement: Physical examination.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-24</approval_date>
        <contact_name>Ethics Committee in Biomedical Research, Imam Khomeini Hospital, Tehran University of Medical Scienc</contact_name>
        <contact_address>Keshavarz blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
