<?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>IRCT20160809029286N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-28</date_registration>
      <primary_sponsor>Joint Reconstruction Research Center</primary_sponsor>
      <public_title>The comparison of clinical outcome Laser and Light Method following Total Knee Arthroplasty</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of clinical outcome Low Level Laser and Light Therapy on TKA patients: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46336</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the type of modalities we will use during rehabilitation after TKA, 45 patients will randomize into three groups including control, LLLT and light (15 patients per group). Randomization will performed by the four-block technique. Patient and assessor who will gather the data will blinded about the type of treatment modality (Double-Blinded). We will use a randomization table and will divide all the patients into four blocks. The patients will allocate to three groups based on the treatment including Light, LLLT, and control groups, Blinding description: Randomization will performed by the four-block technique. Patient and assessor who will gather the data will blinded about the type of treatment modality (Double-Blinded). The patient and investigator will blinded about type of Intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: light (Bioptron light) , The patients received (Bioptron) light and the same exercise program quadriceps isometric with ice which applied during first 3days after the operation. Intervention 2: Intervention group: LLLT (Low-Level Laser) or RJ laser, The patients received 804 nm GA AL AS LLLT (RJ laser) at power out of 500 mv and a degree of dosage 10J per session in 2 points (5J/Point) on posterior of the knee, which applied during first 3days after the operation. They receive same exercise and ice. Intervention 3: Control group: The Patients just received an exercise program with ice as in all groups.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The article will published

When:
2021 January

To whom:
All faculty membership

Conditions:
none

Where to obtain:
Alireza Moharrami Email: a.moharramy@gmail.com

How to obtain:
please send Email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Moharrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran , IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955743849</zip>
        <telephone>+98 21 6119 0000</telephone>
        <email>a-moharrami@student.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Seyed Mohammad Javad Mortazavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6653 1354</telephone>
        <email>smjmort@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients who underwent TKA for primary knee osteoarthritis at our institution
The patients with inform consent to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients with TKA due to secondary osteoarthritis such as rheumatoid arthritis and other rheumatologic condition, posttraumatic arthritis
The patients who had difficulty in communication due to cognitive dysfunction or mental retardation
The patients with comorbidities such as diabetes or other neurological problems
Revision TKA  patients
The patients who developed deep vein thrombosis or  infections in postoperative period
The patients who were unwilling to participate in the study</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: light (Bioptron light) , The patients received (Bioptron) light and the same exercise program quadriceps isometric with ice which applied during first 3days after the operation.</i_keyword>
      <i_keyword>Intervention group: LLLT (Low-Level Laser) or RJ laser, The patients received 804 nm GA AL AS LLLT (RJ laser) at power out of 500 mv and a degree of dosage 10J per session in 2 points (5J/Point) on posterior of the knee, which applied during first 3days after the operation. They receive same exercise and ice.</i_keyword>
      <i_keyword>Control group: The Patients just received an exercise program with ice as in all groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee Society Score. Timepoint: Preoperative and 3 months post operative. Method of measurement: Based on the Knee Society Score form (0-100).</prim_outcome>
      <prim_outcome>Functional Knee Society Score. Timepoint: Preoperative and 3 months post operative. Method of measurement: Based on the Knee Society Score form (0-100).</prim_outcome>
      <prim_outcome>Pain Visual Analog Scale (VAS). Timepoint: preoperative, first day, second day and third day postoperative, 3 months post operative. Method of measurement: Based on the pain in Visual Analog Scale (VAS) (0-10 scores).</prim_outcome>
      <prim_outcome>Knee Range of Motion. Timepoint: preoperative, first day, second day and third day postoperative, 3 months post operative. Method of measurement: Based on the measurement between full flexion and full extension by goniometer (0 to 140 degrees).</prim_outcome>
      <prim_outcome>Swelling. Timepoint: preoperative, first day, second day and third day postoperative, 3 months post operative. Method of measurement: the measure around of proximal of leg base on mm.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>None</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-01</approval_date>
        <contact_name>Tehran University of Medical Sciences Ethic Committee</contact_name>
        <contact_address>Imam Khomeini Hospital, End of Keshavarz blvd, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
