xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032039</url>
    </required_header>
    <id_info>
      <org_study_id>CREC-MN.023, 2022/2023</org_study_id>
      <nct_id>NCT06032039</nct_id>
    </id_info>
    <brief_title>Corticosteroid vs Platelet-Rich Plasma Intra-articular Injections in the Treatment of Knee Osteoarthritis.</brief_title>
    <official_title>Corticosteroid vs Platelet-Rich Plasma Intra-articular Injections in the Treatment of Knee Osteoarthritis in Patients Fifty Years and Older: a Look at Pain and Functional Outcomes at a Single Institution.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of The West Indies</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of The West Indies</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will explore the effectiveness of intra-articular knee injections in patients with&#xD;
        osteoarthritis by comparing Corticosteroid (triamcinolone) vs Platelet Rich Plasma (PRP).&#xD;
  &#xD;
        This study is a randomized controlled trial with a sample size of one hundred and sixty&#xD;
        patients (160). Patients would be recruited via new referrals and follow-up appointments in&#xD;
        the Orthopaedic clinic at the UHWI (University Hospital of the West Indies) with knee&#xD;
        osteoarthritis.&#xD;
  &#xD;
        The aim of the study is to:&#xD;
  &#xD;
          1. To determine if platelet-rich plasma injections are better at improving functional&#xD;
             outcomes in the knee using Western Ontario and McMaster Universities Arthritis Index&#xD;
             (WOMAC) when compared to intraarticular steroids.&#xD;
  &#xD;
          2. To identify adverse reactions related to these injections&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will explore the effectiveness of intra-articular knee injections in patients with&#xD;
        osteoarthritis by comparing Corticosteroid (triamcinolone) vs Platelet Rich Plasma (PRP).&#xD;
  &#xD;
        This study is a randomized controlled trial with a sample size of one hundred and sixty&#xD;
        patients (160). Patients would be recruited via new referrals and follow-up appointments in&#xD;
        the Orthopaedic clinic at the UHWI (University Hospital of the West Indies) with knee&#xD;
        osteoarthritis.&#xD;
  &#xD;
        The recruitment period will run from July 31, 2023 to January 31, 2024 and a subsequent year&#xD;
        of follow-up for each patient.&#xD;
  &#xD;
        Selected patients will be informed of the study and given informed consent to fill out once&#xD;
        they meet the inclusion criteria. Information will be stored on a password-encrypted external&#xD;
        storage device that can only be accessed by the investigator or supervisor. Data will be&#xD;
        analyzed using Statistical Package for the Social Sciences (SPSS).&#xD;
  &#xD;
        The study will be conducted according to the good clinical practice guidelines of the World&#xD;
        Medical Association (WMA) declaration of Helsinki which addresses research on human subjects&#xD;
        and will conform to local laws and ethical requirements of the Ministry of Health.&#xD;
  &#xD;
        The study will provide information on the effectiveness of two non-operative management of&#xD;
        osteoarthritis of the knee; in the form of Platelet-rich plasma and corticosteroid injection.&#xD;
        Results from the study can be used as a reference point for future treatment in patients with&#xD;
        knee osteoarthritis.&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
        PRP is superior to corticosteroid intra-articular injection over one year for knee pain and&#xD;
        functional outcome in patients with osteoarthritis of the knee&#xD;
  &#xD;
        Design This study is a randomized controlled double-blinded trial. Patients with knee&#xD;
        osteoarthritis would be recruited via new referrals and follow-up appointments in the&#xD;
        Orthopaedic clinic at the UHWI (University Hospital of the West Indies).&#xD;
  &#xD;
        The intervention will be done in the minor operating room at no additional cost to the&#xD;
        patient. All the equipment needed will be provided via funding.&#xD;
  &#xD;
          -  Using the WOMAC scores and visual analogue scale, pain and functional outcomes before&#xD;
             and after the procedures will be studied to assess if PRP injection is superior to&#xD;
             steroid injection.&#xD;
  &#xD;
          -  Selected patients will be informed of the study and given an informed consent to fill&#xD;
             out once they meet inclusion criteria. Persons consenting will be Orthopaedic residents&#xD;
             knowledgeable of the study but will not be a part of the care.&#xD;
  &#xD;
          -  One person who is not a part of analyzing the data will be in charge of assigning the&#xD;
             unique identifying number to each tested knee prior to the start of the study.&#xD;
  &#xD;
          -  WOMAC questionnaire will be administered at the outpatient clinic visits prior to&#xD;
             injection, at two weeks, three months, six months, and a year post-injection.&#xD;
  &#xD;
          -  Information will be stored on a password-encrypted external storage device that can only&#xD;
             be accessed by the investigator or supervisor. Data will be analyzed using Statistical&#xD;
             Package for the Social Sciences (SPSS)&#xD;
  &#xD;
        Research-related justification for sample size:&#xD;
  &#xD;
        The sample size was calculated to be one hundred and sixty patients (160). Calculations for&#xD;
        the sample size were done using the formula to calculate the sample size for a two-sample&#xD;
        test of means; independent samples T-test. Where:&#xD;
  &#xD;
        The type I error rate (5%) The type II error rate (20%)&#xD;
  &#xD;
        = The effect size (set at 0.5 for a medium effect size).&#xD;
  &#xD;
        Yields a sample size of 64 participants for each group. It is recommended to account for a&#xD;
        loss to follow-up of at least 20%, bringing the sample size required for each group to 80,&#xD;
        for a total sample size of 160.&#xD;
  &#xD;
        Additionally, when considering sample size estimates a larger sample size is always&#xD;
        considered better. To estimate a linear regression model to control for other factors such as&#xD;
        age and sex, Green (1991) recommends that the sample size should be at least 50 +8*(number of&#xD;
        predictors). When seeking to test individual predictors, Green's rule of thumb for a medium&#xD;
        effect size is that the sample size be at least 104 + predictors.&#xD;
  &#xD;
        Using the estimate of 160, the study should be adequately powered for analysis testing the&#xD;
        hypothesis of WOMAC pain scores being different in the group receiving PRP injections&#xD;
        compared to the group receiving corticosteroid injection, while controlling for 2 - 3 other&#xD;
        characteristics.&#xD;
  &#xD;
        Patients will be randomized with the help of an online randomization tool (National Cancer&#xD;
        Institute Clinical Trial randomization tool) being placed in one of two arms, corticosteroid&#xD;
        vs PRP injection.&#xD;
  &#xD;
        Patients will be recruited by the investigator and recruited for the study over 6 months with&#xD;
        a further follow-up of up to one year post-injection. The persons assessing the patients at&#xD;
        each visit plus the physiotherapist will not be aware of the intervention given.&#xD;
  &#xD;
        Patients will be given a single injection of either PRP or corticosteroids (triamcinolone).&#xD;
  &#xD;
        All injections will be given by persons post part 1 in the Doctorate of Medicine Orthopaedic&#xD;
        program or higher except for the investigators. All patients will have 30 ml of blood taken&#xD;
        in an area separate from the location of the centrifuge machine to prepare the PRP.&#xD;
  &#xD;
        Patients and administrators will be blinded to the injection by wrapping each syringe before&#xD;
        injection. All patients will be injected 20 minutes after the blood has been drawn. The tubes&#xD;
        will be sorted by an individual who will know about the desired randomization. Patients will&#xD;
        be blinded to the injection as the syringe will be wrapped to hide its content, this will&#xD;
        also blind the person administering the injection; who is separate from the person preparing.&#xD;
  &#xD;
        The steroid injections are commercially packaged as 40mg/ml. 80 mg of triamcinolone will be&#xD;
        used for patients receiving steroids. Preparation of the PRP will be done by the PRP method.&#xD;
  &#xD;
        PRP method:&#xD;
  &#xD;
          1. Obtain 30mls Whole Blood by venepuncture in acid citrate dextrose (ACD) tubes&#xD;
  &#xD;
          2. Do not chill the blood at any time before or during platelet separation.&#xD;
  &#xD;
          3. Centrifuge the blood using a 'soft' spin.&#xD;
  &#xD;
          4. Transfer the supernatant plasma containing platelets into another sterile tube (without&#xD;
             anticoagulant).&#xD;
  &#xD;
          5. Centrifuge tube at a higher speed (a hard spin ) to obtain a platelet concentrate.&#xD;
  &#xD;
          6. The lower 1/3rd is PRP and upper 2/3rd is platelet- poor plasma (PPP). At the bottom of&#xD;
             the tube, platelet pellets are formed.&#xD;
  &#xD;
          7. Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by&#xD;
             gently shaking the tube.&#xD;
  &#xD;
        The procedure will be done in the minor operating theatre. Patients will be adequately&#xD;
        cleaned with betadine or hibitane in alcohol before venepuncture. Blood will then be brought&#xD;
        to a separate sterile room for preparation. Injections will be given under aseptic&#xD;
        conditions. The area will be cleaned thoroughly with Povidone-Iodine or Hibitane in 70%&#xD;
        Alcohol, depending on the allergy profiles of the patients. With the knee flexed to ninety&#xD;
        degrees injection will be given with a 22 gauge needle through the lateral parapatellar&#xD;
        space. Dressings will then be applied and patients will be observed for five minutes after&#xD;
        the injections, post-procedural analgesics will be given for two days.&#xD;
  &#xD;
        Patients will be assessed before injection, at 2 weeks, 3 months, 6 months, and a year&#xD;
        post-injection using the WOMAC (Western Ontario and McMaster Osteoarthritis index) and Visual&#xD;
        Analogue Score (VAS), by a trained physician who will be blinded to the interventions. There&#xD;
        will also be a standardized rehab program for osteoarthritis of the knee developed by the&#xD;
        physiotherapy department. This program will be administered for a duration of 6 months to all&#xD;
        patients by volunteer registered Physiotherapists in the department.&#xD;
  &#xD;
        The proposed start time of the study is July 2023 with the recruitment of patients over 6&#xD;
        months, followed by a one-year follow-up for each patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain of the Knee</measure>
      <time_frame>1 year of follow up visits, post injection. Follow up will be done at 2 weeks, 3 months, 6 months, and 1 year.</time_frame>
      <description>For pain we are primarily using the visual Analogue scale, which is a subjective pain rating numerical scale where the patients rate their pain on a scale of 0-10.&#xD;
  The Visual Analogue Scale is a scale from 0-10, where 0 = No Pain and 10 = Worst Pain Possible. The scale also uses faces to indicate the level of pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Function of the knee</measure>
      <time_frame>1 year of follow up visits, post injection. Follow up will be done at 2 weeks, 3 months, 6 months, and 1 year.</time_frame>
      <description>For Function we are primarily using the Western Ontario and McMaster Universities Arthritis index (WOMAC), which is a commonly used tool to assess pain and function in patients with arthritis. This is a self administered questionnaire with 24 items in 3 subscales (1) 5 points evaluate pain (2) 2 points stiffness (3) 17 points function a numerical score is calculated and used for comparison.&#xD;
  The WOMAC index uses a scale of 0-4 to rate pain, stiffness and difficulty when doing certain activities, where 0 = None and 4 = Extreme.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Corticosteroid Injection</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm will receive a corticosteroid (Triamcinalone) injection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Platelet Rich Plasma Injection (PRP)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm will receive a PRP injection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Triamcinolone</intervention_name>
      <description>Standard treatment for osteoarthritis knee pain</description>
      <arm_group_label>Corticosteroid Injection</arm_group_label>
      <other_name>Corticosteroid</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Platelet Rich Plasma</intervention_name>
      <description>Alternative treatment for osteoarthritis knee pain</description>
      <arm_group_label>Platelet Rich Plasma Injection (PRP)</arm_group_label>
      <other_name>PRP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Kellgren and Lawrence grades 2-3 Age 50 years and older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with secondary OA:&#xD;
  &#xD;
            2. History of Fractures around the knee joint i. patella ii. tibia plateau iii. intra&#xD;
               articular distal femur&#xD;
  &#xD;
            3. Bleeding diathesis&#xD;
  &#xD;
            4. History of septic arthritis&#xD;
  &#xD;
            5. Patients on oral steroid medications&#xD;
  &#xD;
            6. Patients who received intraarticular steroid injection &lt; 6 months before enrollment&#xD;
  &#xD;
            7. Sickle Cell Disease&#xD;
  &#xD;
            8. Rheumatoid arthritis&#xD;
  &#xD;
            9. Patients with a diagnosis of knee OA with little or no pain&#xD;
  &#xD;
           10. Patient with a diagnosis of knee OA being successfully managed with oral medications&#xD;
               and physiotherapy&#xD;
  &#xD;
           11. Knee pain not attributed to a diagnosis of OA&#xD;
  &#xD;
           12. All patients who refuse to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wayne Palmer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Doctor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Principal Investigator</last_name>
      <phone>(876) 371-7045</phone>
      <email>wayne.palmer02@uwimona.edu.jm</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Researcher</last_name>
      <phone>(876) 774-4606</phone>
      <email>raheem.nelson02@mymonauwi.edu.jm</email>
    </overall_contact_backup>
    <reference>
      <citation>Forogh B, Mianehsaz E, Shoaee S, Ahadi T, Raissi GR, Sajadi S. Effect of single injection of platelet-rich plasma in comparison with corticosteroid on knee osteoarthritis: a double-blind randomized clinical trial. J Sports Med Phys Fitness. 2016 Jul-Aug;56(7-8):901-8. Epub 2015 Jul 14.</citation>
      <PMID>26173792</PMID>
    </reference>
    <reference>
      <citation>Hirsch G, Kitas G, Klocke R. Intra-articular corticosteroid injection in osteoarthritis of the knee and hip: factors predicting pain relief--a systematic review. Semin Arthritis Rheum. 2013 Apr;42(5):451-73. doi: 10.1016/j.semarthrit.2012.08.005. Epub 2013 Jan 29.</citation>
      <PMID>23374502</PMID>
    </reference>
    <reference>
      <citation>Migliorini F, Driessen A, Quack V, Sippel N, Cooper B, Mansy YE, Tingart M, Eschweiler J. Comparison between intra-articular infiltrations of placebo, steroids, hyaluronic and PRP for knee osteoarthritis: a Bayesian network meta-analysis. Arch Orthop Trauma Surg. 2021 Sep;141(9):1473-1490. doi: 10.1007/s00402-020-03551-y. Epub 2020 Jul 28.</citation>
      <PMID>32725315</PMID>
    </reference>
    <reference>
      <citation>Richards MM, Maxwell JS, Weng L, Angelos MG, Golzarian J. Intra-articular treatment of knee osteoarthritis: from anti-inflammatories to products of regenerative medicine. Phys Sportsmed. 2016;44(2):101-8. doi: 10.1080/00913847.2016.1168272. Epub 2016 Apr 4.</citation>
      <PMID>26985986</PMID>
    </reference>
    <reference>
      <citation>Rayegani SM, Raeissadat SA, Taheri MS, Babaee M, Bahrami MH, Eliaspour D, Ghorbani E. Does intra articular platelet rich plasma injection improve function, pain and quality of life in patients with osteoarthritis of the knee? A randomized clinical trial. Orthop Rev (Pavia). 2014 Sep 18;6(3):5405. doi: 10.4081/or.2014.5405. eCollection 2014 Aug 8.</citation>
      <PMID>25317308</PMID>
    </reference>
    <reference>
      <citation>Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.</citation>
      <PMID>26233594</PMID>
    </reference>
    <reference>
      <citation>Liow Y, Wang W, Loh VW. Outpatient management of knee osteoarthritis. Singapore Med J. 2017 Oct;58(10):580-584. doi: 10.11622/smedj.2017097.</citation>
      <PMID>29119193</PMID>
    </reference>
    <reference>
      <citation>Paik J, Duggan ST, Keam SJ. Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Drugs. 2019 Mar;79(4):455-462. doi: 10.1007/s40265-019-01083-3. Erratum In: Drugs. 2019 Apr;79(5):587. Drugs. 2019 Apr 3;: Drugs. 2019 Sep 6;:</citation>
      <PMID>30847805</PMID>
    </reference>
    <reference>
      <citation>Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.</citation>
      <PMID>32551947</PMID>
    </reference>
    <reference>
      <citation>Green SB. How Many Subjects Does It Take To Do A Regression Analysis. Multivariate Behav Res. 1991 Jul 1;26(3):499-510. doi: 10.1207/s15327906mbr2603_7.</citation>
      <PMID>26776715</PMID>
    </reference>
    <reference>
      <citation>Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.</citation>
      <PMID>25722595</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Osteoarthritis</keyword>
    <keyword>Knee</keyword>
    <keyword>Corticosteroid</keyword>
    <keyword>Platelet Rich Plasma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Triamcinolone</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032039
  org study id: CREC-MN.023, 2022/2023
  nct id: NCT06032039
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study will explore the effectiveness of intra-articular knee injections in patients with
        osteoarthritis by comparing Corticosteroid (triamcinolone) vs Platelet Rich Plasma (PRP).
  
        This study is a randomized controlled trial with a sample size of one hundred and sixty
        patients (160). Patients would be recruited via new referrals and follow-up appointments in
        the Orthopaedic clinic at the UHWI (University Hospital of the West Indies) with knee
        osteoarthritis.
  
        The aim of the study is to:
  
          1. To determine if platelet-rich plasma injections are better at improving functional
             outcomes in the knee using Western Ontario and McMaster Universities Arthritis Index
             (WOMAC) when compared to intraarticular steroids.
  
          2. To identify adverse reactions related to these injections
  This study will explore the effectiveness of intra-articular knee injections in patients with
        osteoarthritis by comparing Corticosteroid (triamcinolone) vs Platelet Rich Plasma (PRP).
  
        This study is a randomized controlled trial with a sample size of one hundred and sixty
        patients (160). Patients would be recruited via new referrals and follow-up appointments in
        the Orthopaedic clinic at the UHWI (University Hospital of the West Indies) with knee
        osteoarthritis.
  
        The recruitment period will run from July 31, 2023 to January 31, 2024 and a subsequent year
        of follow-up for each patient.
  
        Selected patients will be informed of the study and given informed consent to fill out once
        they meet the inclusion criteria. Information will be stored on a password-encrypted external
        storage device that can only be accessed by the investigator or supervisor. Data will be
        analyzed using Statistical Package for the Social Sciences (SPSS).
  
        The study will be conducted according to the good clinical practice guidelines of the World
        Medical Association (WMA) declaration of Helsinki which addresses research on human subjects
        and will conform to local laws and ethical requirements of the Ministry of Health.
  
        The study will provide information on the effectiveness of two non-operative management of
        osteoarthritis of the knee; in the form of Platelet-rich plasma and corticosteroid injection.
        Results from the study can be used as a reference point for future treatment in patients with
        knee osteoarthritis.
  
        Hypothesis:
  
        PRP is superior to corticosteroid intra-articular injection over one year for knee pain and
        functional outcome in patients with osteoarthritis of the knee
  
        Design This study is a randomized controlled double-blinded trial. Patients with knee
        osteoarthritis would be recruited via new referrals and follow-up appointments in the
        Orthopaedic clinic at the UHWI (University Hospital of the West Indies).
  
        The intervention will be done in the minor operating room at no additional cost to the
        patient. All the equipment needed will be provided via funding.
  
          -  Using the WOMAC scores and visual analogue scale, pain and functional outcomes before
             and after the procedures will be studied to assess if PRP injection is superior to
             steroid injection.
  
          -  Selected patients will be informed of the study and given an informed consent to fill
             out once they meet inclusion criteria. Persons consenting will be Orthopaedic residents
             knowledgeable of the study but will not be a part of the care.
  
          -  One person who is not a part of analyzing the data will be in charge of assigning the
             unique identifying number to each tested knee prior to the start of the study.
  
          -  WOMAC questionnaire will be administered at the outpatient clinic visits prior to
             injection, at two weeks, three months, six months, and a year post-injection.
  
          -  Information will be stored on a password-encrypted external storage device that can only
             be accessed by the investigator or supervisor. Data will be analyzed using Statistical
             Package for the Social Sciences (SPSS)
  
        Research-related justification for sample size:
  
        The sample size was calculated to be one hundred and sixty patients (160). Calculations for
        the sample size were done using the formula to calculate the sample size for a two-sample
        test of means; independent samples T-test. Where:
  
        The type I error rate (5%) The type II error rate (20%)
  
        = The effect size (set at 0.5 for a medium effect size).
  
        Yields a sample size of 64 participants for each group. It is recommended to account for a
        loss to follow-up of at least 20%, bringing the sample size required for each group to 80,
        for a total sample size of 160.
  
        Additionally, when considering sample size estimates a larger sample size is always
        considered better. To estimate a linear regression model to control for other factors such as
        age and sex, Green (1991) recommends that the sample size should be at least 50 +8*(number of
        predictors). When seeking to test individual predictors, Green's rule of thumb for a medium
        effect size is that the sample size be at least 104 + predictors.
  
        Using the estimate of 160, the study should be adequately powered for analysis testing the
        hypothesis of WOMAC pain scores being different in the group receiving PRP injections
        compared to the group receiving corticosteroid injection, while controlling for 2 - 3 other
        characteristics.
  
        Patients will be randomized with the help of an online randomization tool (National Cancer
        Institute Clinical Trial randomization tool) being placed in one of two arms, corticosteroid
        vs PRP injection.
  
        Patients will be recruited by the investigator and recruited for the study over 6 months with
        a further follow-up of up to one year post-injection. The persons assessing the patients at
        each visit plus the physiotherapist will not be aware of the intervention given.
  
        Patients will be given a single injection of either PRP or corticosteroids (triamcinolone).
  
        All injections will be given by persons post part 1 in the Doctorate of Medicine Orthopaedic
        program or higher except for the investigators. All patients will have 30 ml of blood taken
        in an area separate from the location of the centrifuge machine to prepare the PRP.
  
        Patients and administrators will be blinded to the injection by wrapping each syringe before
        injection. All patients will be injected 20 minutes after the blood has been drawn. The tubes
        will be sorted by an individual who will know about the desired randomization. Patients will
        be blinded to the injection as the syringe will be wrapped to hide its content, this will
        also blind the person administering the injection; who is separate from the person preparing.
  
        The steroid injections are commercially packaged as 40mg/ml. 80 mg of triamcinolone will be
        used for patients receiving steroids. Preparation of the PRP will be done by the PRP method.
  
        PRP method:
  
          1. Obtain 30mls Whole Blood by venepuncture in acid citrate dextrose (ACD) tubes
  
          2. Do not chill the blood at any time before or during platelet separation.
  
          3. Centrifuge the blood using a 'soft' spin.
  
          4. Transfer the supernatant plasma containing platelets into another sterile tube (without
             anticoagulant).
  
          5. Centrifuge tube at a higher speed (a hard spin ) to obtain a platelet concentrate.
  
          6. The lower 1/3rd is PRP and upper 2/3rd is platelet- poor plasma (PPP). At the bottom of
             the tube, platelet pellets are formed.
  
          7. Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by
             gently shaking the tube.
  
        The procedure will be done in the minor operating theatre. Patients will be adequately
        cleaned with betadine or hibitane in alcohol before venepuncture. Blood will then be brought
        to a separate sterile room for preparation. Injections will be given under aseptic
        conditions. The area will be cleaned thoroughly with Povidone-Iodine or Hibitane in 70%
        Alcohol, depending on the allergy profiles of the patients. With the knee flexed to ninety
        degrees injection will be given with a 22 gauge needle through the lateral parapatellar
        space. Dressings will then be applied and patients will be observed for five minutes after
        the injections, post-procedural analgesics will be given for two days.
  
        Patients will be assessed before injection, at 2 weeks, 3 months, 6 months, and a year
        post-injection using the WOMAC (Western Ontario and McMaster Osteoarthritis index) and Visual
        Analogue Score (VAS), by a trained physician who will be blinded to the interventions. There
        will also be a standardized rehab program for osteoarthritis of the knee developed by the
        physiotherapy department. This program will be administered for a duration of 6 months to all
        patients by volunteer registered Physiotherapists in the department.
  
        The proposed start time of the study is July 2023 with the recruitment of patients over 6
        months, followed by a one-year follow-up for each patient.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Pain of the Knee
  time frame: 1 year of follow up visits, post injection. Follow up will be done at 2 weeks, 3 months, 6 months, and 1 year.
  description: For pain we are primarily using the visual Analogue scale, which is a subjective pain rating numerical scale where the patients rate their pain on a scale of 0-10.
  The Visual Analogue Scale is a scale from 0-10, where 0 = No Pain and 10 = Worst Pain Possible. The scale also uses faces to indicate the level of pain.
  measure: Function of the knee
  time frame: 1 year of follow up visits, post injection. Follow up will be done at 2 weeks, 3 months, 6 months, and 1 year.
  description: For Function we are primarily using the Western Ontario and McMaster Universities Arthritis index (WOMAC), which is a commonly used tool to assess pain and function in patients with arthritis. This is a self administered questionnaire with 24 items in 3 subscales (1) 5 points evaluate pain (2) 2 points stiffness (3) 17 points function a numerical score is calculated and used for comparison.
  The WOMAC index uses a scale of 0-4 to rate pain, stiffness and difficulty when doing certain activities, where 0 = None and 4 = Extreme.
  arm group label: Corticosteroid Injection
  arm group type: Active Comparator
  description: This arm will receive a corticosteroid (Triamcinalone) injection.
  arm group label: Platelet Rich Plasma Injection (PRP)
  arm group type: Active Comparator
  description: This arm will receive a PRP injection.
  intervention type: Drug
  intervention name: Triamcinolone
  description: Standard treatment for osteoarthritis knee pain
  arm group label: Corticosteroid Injection
  other name: Corticosteroid
  intervention type: Other
  intervention name: Platelet Rich Plasma
  description: Alternative treatment for osteoarthritis knee pain
  arm group label: Platelet Rich Plasma Injection (PRP)
  other name: PRP
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wayne Palmer
  role: Principal Investigator
  affiliation: Doctor
  last name: Principal Investigator
  phone: (876) 371-7045
  email: wayne.palmer02@uwimona.edu.jm
  last name: Researcher
  phone: (876) 774-4606
  email: raheem.nelson02@mymonauwi.edu.jm
  citation: Forogh B, Mianehsaz E, Shoaee S, Ahadi T, Raissi GR, Sajadi S. Effect of single injection of platelet-rich plasma in comparison with corticosteroid on knee osteoarthritis: a double-blind randomized clinical trial. J Sports Med Phys Fitness. 2016 Jul-Aug;56(7-8):901-8. Epub 2015 Jul 14.
  PMID: 26173792
  citation: Hirsch G, Kitas G, Klocke R. Intra-articular corticosteroid injection in osteoarthritis of the knee and hip: factors predicting pain relief--a systematic review. Semin Arthritis Rheum. 2013 Apr;42(5):451-73. doi: 10.1016/j.semarthrit.2012.08.005. Epub 2013 Jan 29.
  PMID: 23374502
  citation: Migliorini F, Driessen A, Quack V, Sippel N, Cooper B, Mansy YE, Tingart M, Eschweiler J. Comparison between intra-articular infiltrations of placebo, steroids, hyaluronic and PRP for knee osteoarthritis: a Bayesian network meta-analysis. Arch Orthop Trauma Surg. 2021 Sep;141(9):1473-1490. doi: 10.1007/s00402-020-03551-y. Epub 2020 Jul 28.
  PMID: 32725315
  citation: Richards MM, Maxwell JS, Weng L, Angelos MG, Golzarian J. Intra-articular treatment of knee osteoarthritis: from anti-inflammatories to products of regenerative medicine. Phys Sportsmed. 2016;44(2):101-8. doi: 10.1080/00913847.2016.1168272. Epub 2016 Apr 4.
  PMID: 26985986
  citation: Rayegani SM, Raeissadat SA, Taheri MS, Babaee M, Bahrami MH, Eliaspour D, Ghorbani E. Does intra articular platelet rich plasma injection improve function, pain and quality of life in patients with osteoarthritis of the knee? A randomized clinical trial. Orthop Rev (Pavia). 2014 Sep 18;6(3):5405. doi: 10.4081/or.2014.5405. eCollection 2014 Aug 8.
  PMID: 25317308
  citation: Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.
  PMID: 26233594
  citation: Liow Y, Wang W, Loh VW. Outpatient management of knee osteoarthritis. Singapore Med J. 2017 Oct;58(10):580-584. doi: 10.11622/smedj.2017097.
  PMID: 29119193
  citation: Paik J, Duggan ST, Keam SJ. Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Drugs. 2019 Mar;79(4):455-462. doi: 10.1007/s40265-019-01083-3. Erratum In: Drugs. 2019 Apr;79(5):587. Drugs. 2019 Apr 3;: Drugs. 2019 Sep 6;:
  PMID: 30847805
  citation: Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.
  PMID: 32551947
  citation: Green SB. How Many Subjects Does It Take To Do A Regression Analysis. Multivariate Behav Res. 1991 Jul 1;26(3):499-510. doi: 10.1207/s15327906mbr2603_7.
  PMID: 26776715
  citation: Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
  PMID: 25722595
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Triamcinolone