<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/NCT01692756</url>
  </required_header>
  <id_info>
    <org_study_id>12-0706</org_study_id>
    <nct_id>NCT01692756</nct_id>
  </id_info>
  <brief_title>Early Treatment for Acute ACL Tear</brief_title>
  <acronym>AAA</acronym>
  <official_title>Early Anti-inflammatory Treatment in Patients With Acute ACL Tear</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cale Jacobs</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is the first of its kind and will allow health care professionals and&#xD;
      researchers to answer many questions about the reasons why anterior cruciate ligament (ACL)&#xD;
      injury leads to knee pain and disability and osteoarthritis. We also hope that this study&#xD;
      will be the beginning of new, more powerful and safer drugs to help patients with ACL&#xD;
      injuries heal sooner and return to sports or daily activities pain free. Study participants&#xD;
      will be recruited from the University of Kentucky and Vanderbilt University.&#xD;
&#xD;
      The purpose of this research is to gather information on how safe and effective Kenalog® is&#xD;
      in alleviating knee pain following ACL rupture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Injury to the knee during sports participation often involves partial of full detachment of&#xD;
      the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation&#xD;
      usually goes away in time, individuals with ACL injuries may experience pain and notice knee&#xD;
      instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the&#xD;
      joint, allowing individuals the ability to walk or run again pain free or participate in&#xD;
      sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can&#xD;
      occur in that same knee 10-20 years later for reasons which are not well understood.&#xD;
&#xD;
      In this research study, we hope to prevent and reduce the initial post-operative pain. The&#xD;
      reduction of pain will allow for earlier movement of the knee joint and preparation for&#xD;
      surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL&#xD;
      injuries by treating them within 1-2 days after their injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">February 5, 2017</completion_date>
  <primary_completion_date type="Actual">February 5, 2017</primary_completion_date>
  <phase>Phase 2</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant Pain Assessment</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of Kenalog to Alleviate Knee Pain</measure>
    <time_frame>Up to seven days</time_frame>
    <description>The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Interleukin-1α (IL-1α) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Interleukin-1β (IL-1β) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial C-terminal Peptide II (CTXII) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Glycosaminoglycans (GAG) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration</measure>
    <time_frame>Up to seven days</time_frame>
    <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Anterior Cruciate Ligament (ACL) Tears</condition>
  <arm_group>
    <arm_group_label>Kenalog or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kenalog then placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kenalog only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kenalog or placebo</intervention_name>
    <arm_group_label>Kenalog or Placebo</arm_group_label>
    <other_name>Drug: Kenalog</other_name>
    <other_name>Other Names:</other_name>
    <other_name>triamcinolone acetonide injectable suspension</other_name>
    <other_name>Drug Placebo (for Kenalog)</other_name>
    <other_name>physiologic Saline solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kenalog then Placebo</intervention_name>
    <arm_group_label>Kenalog then placebo</arm_group_label>
    <other_name>Drug: Kenalog</other_name>
    <other_name>Other Names:</other_name>
    <other_name>triamcinolone acetonide injectable suspension</other_name>
    <other_name>Drug Placebo (for Kenalog)</other_name>
    <other_name>physiologic saline solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kenalog</intervention_name>
    <arm_group_label>Kenalog only</arm_group_label>
    <other_name>Drug: Kenalog</other_name>
    <other_name>Other Names:</other_name>
    <other_name>triamcinolone acetonide injectable suspension</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Drug Placebo (for Kenalog)</other_name>
    <other_name>physiologic saline solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  currently participating in sporting activities&#xD;
&#xD;
          -  Normal contralateral knee status&#xD;
&#xD;
          -  Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.)&#xD;
&#xD;
          -  have been diagnosed with hepatitis B or tuberculosis&#xD;
&#xD;
          -  currently have an infection, including infection of the skin&#xD;
&#xD;
          -  have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs&#xD;
&#xD;
          -  other major medical condition requiring treatment with immunosuppressant or modulating&#xD;
             drugs.&#xD;
&#xD;
          -  A history of chronic use of non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  previous exposure or allergic reaction to Kenalog&#xD;
&#xD;
          -  prior knee surgery (Ipsilateral or contralateral)&#xD;
&#xD;
          -  have received any investigational drug with 4 weeks of study Visit 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>33 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Lattermann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky, Department of Orthopaedic Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UK HeathCare Sports Medicine</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Lattermann C, Jacobs CA, Proffitt Bunnell M, Huston LJ, Gammon LG, Johnson DL, Reinke EK, Huebner JL, Kraus VB, Spindler KP. A Multicenter Study of Early Anti-inflammatory Treatment in Patients With Acute Anterior Cruciate Ligament Tear. Am J Sports Med. 2017 Feb;45(2):325-333. doi: 10.1177/0363546516666818. Epub 2016 Oct 7.</citation>
    <PMID>28146402</PMID>
  </results_reference>
  <results_reference>
    <citation>Lattermann C, Jacobs CA, Bunnell MP, Jochimsen KN, Abt JP, Reinke EK, Gammon LG, Huebner JL, Kraus VB, Spindler KP. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res. 2017 Mar;35(3):641-650. doi: 10.1002/jor.23329. Epub 2016 Jun 30.</citation>
    <PMID>27279368</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>April 2, 2018</results_first_submitted>
  <results_first_submitted_qc>October 13, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 13, 2018</results_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Cale Jacobs</investigator_full_name>
    <investigator_title>Sponsor/Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 4, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT01692756/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Kenalog or Placebo</title>
          <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
        </group>
        <group group_id="P2">
          <title>Kenalog Then Placebo</title>
          <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
        </group>
        <group group_id="P3">
          <title>Kenalog Only</title>
          <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One patient was lost to follow-up (Group 1). Two patients withdrew prior to receiving treatment (Group 2, Group 3). One patient did not attend first study visit and did not receive allocated intervention (Group 3).</population>
      <group_list>
        <group group_id="B1">
          <title>Kenalog or Placebo</title>
          <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
        </group>
        <group group_id="B2">
          <title>Kenalog Then Placebo</title>
          <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
        </group>
        <group group_id="B3">
          <title>Kenalog Only</title>
          <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="12"/>
            <count group_id="B5" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.45" spread="2.99"/>
                    <measurement group_id="B2" value="19.60" spread="4.12"/>
                    <measurement group_id="B3" value="24.06" spread="6.57"/>
                    <measurement group_id="B4" value="17.80" spread="2.14"/>
                    <measurement group_id="B5" value="19.9" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Knee Injury and Osteoarthritis Scale (KOOS) Pain Subscale</title>
          <description>KOOS consists of 5 subscales with five questions per scale; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The baseline KOOS Pain scores are presented here.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.75" spread="19.10"/>
                    <measurement group_id="B2" value="58.33" spread="15.42"/>
                    <measurement group_id="B3" value="50.25" spread="24.61"/>
                    <measurement group_id="B4" value="46.30" spread="25.02"/>
                    <measurement group_id="B5" value="51.05" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participant Pain Assessment</title>
        <description>Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>A total of 4 patients (Group 1 n:1, Group 2 n:1, Group 4 n:2) overlooked completing the VAS. This was not realized until the patients had left the study visit preventing the investigator from collecting the information.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Pain Assessment</title>
          <description>Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>A total of 4 patients (Group 1 n:1, Group 2 n:1, Group 4 n:2) overlooked completing the VAS. This was not realized until the patients had left the study visit preventing the investigator from collecting the information.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" spread="2.8"/>
                    <measurement group_id="O2" value="-2.2" spread="2.2"/>
                    <measurement group_id="O3" value="-3.6" spread="3.0"/>
                    <measurement group_id="O4" value="-4.3" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.33</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy of Kenalog to Alleviate Knee Pain</title>
        <description>The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).</description>
        <time_frame>Up to seven days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of Kenalog to Alleviate Knee Pain</title>
          <description>The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.37" spread="17.50"/>
                    <measurement group_id="O2" value="18.94" spread="11.02"/>
                    <measurement group_id="O3" value="30.56" spread="23.17"/>
                    <measurement group_id="O4" value="28.93" spread="22.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Interleukin-1α (IL-1α) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>The values for 3 patients (Gp1 n:1, Gp 2 n:1, Gp 3 n:1) were below the limits of detection and were not included in the analysis.Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined 1 aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Interleukin-1α (IL-1α) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>The values for 3 patients (Gp1 n:1, Gp 2 n:1, Gp 3 n:1) were below the limits of detection and were not included in the analysis.Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined 1 aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.30" spread="6.59"/>
                    <measurement group_id="O2" value="7.68" spread="13.15"/>
                    <measurement group_id="O3" value="1.77" spread="4.43"/>
                    <measurement group_id="O4" value="3.11" spread="5.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.93</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Interleukin-1β (IL-1β) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>The values for two patients (Gp1 n:1, Gp 2 n:1) were below the limits of detection and were not included in the analysis. Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined 1 aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Interleukin-1β (IL-1β) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>The values for two patients (Gp1 n:1, Gp 2 n:1) were below the limits of detection and were not included in the analysis. Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined 1 aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.08" spread="2.87"/>
                    <measurement group_id="O2" value="0.75" spread="1.98"/>
                    <measurement group_id="O3" value="-0.28" spread="0.37"/>
                    <measurement group_id="O4" value="-0.19" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3352.5" spread="8285.5"/>
                    <measurement group_id="O2" value="-4955.6" spread="12,939.6"/>
                    <measurement group_id="O3" value="-7278.4" spread="12,581.9"/>
                    <measurement group_id="O4" value="-6888.5" spread="8364.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial C-terminal Peptide II (CTXII) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Group 1 n:1, Group 2 n:1) and 1 patient declined the pre-op assessment aspiration (Group 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial C-terminal Peptide II (CTXII) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Group 1 n:1, Group 2 n:1) and 1 patient declined the pre-op assessment aspiration (Group 3 n:1) preventing analysis on these patients.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" spread="0.21"/>
                    <measurement group_id="O2" value="0.23" spread="0.27"/>
                    <measurement group_id="O3" value="0.19" spread="0.34"/>
                    <measurement group_id="O4" value="1.32" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.003</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Group 1 n:1, Group 2 n:1) and 1 patient declined the pre-op assessment aspiration (Group 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Group 1 n:1, Group 2 n:1) and 1 patient declined the pre-op assessment aspiration (Group 3 n:1) preventing analysis on these patients.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" spread="17.5"/>
                    <measurement group_id="O2" value="-21.7" spread="24.1"/>
                    <measurement group_id="O3" value="-11.7" spread="7.1"/>
                    <measurement group_id="O4" value="-22.1" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.007</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Glycosaminoglycans (GAG) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Glycosaminoglycans (GAG) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-73.1" spread="176.7"/>
                    <measurement group_id="O2" value="155.8" spread="132.4"/>
                    <measurement group_id="O3" value="-49.0" spread="252.5"/>
                    <measurement group_id="O4" value="-167.4" spread="140.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.63</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="7.7"/>
                    <measurement group_id="O2" value="0.6" spread="4.0"/>
                    <measurement group_id="O3" value="2.6" spread="3.6"/>
                    <measurement group_id="O4" value="5.8" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.0" spread="266.0"/>
                    <measurement group_id="O2" value="57.6" spread="244.5"/>
                    <measurement group_id="O3" value="111.4" spread="180.5"/>
                    <measurement group_id="O4" value="-4.9" spread="224.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.62</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="249.0" spread="745.9"/>
                    <measurement group_id="O2" value="-183.0" spread="245.5"/>
                    <measurement group_id="O3" value="-395.5" spread="472.2"/>
                    <measurement group_id="O4" value="-100.4" spread="557.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.02</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2702.9" spread="3937.2"/>
                    <measurement group_id="O2" value="504.0" spread="1705.9"/>
                    <measurement group_id="O3" value="-512.4" spread="2175.0"/>
                    <measurement group_id="O4" value="1295.9" spread="2414.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.20</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration</title>
        <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
        <time_frame>Up to seven days</time_frame>
        <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Kenalog or Placebo</title>
            <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
          </group>
          <group group_id="O2">
            <title>Kenalog Then Placebo</title>
            <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
          </group>
          <group group_id="O3">
            <title>Kenalog Only</title>
            <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration</title>
          <description>Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.</description>
          <population>Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-71.1" spread="15.9"/>
                    <measurement group_id="O2" value="-28.9" spread="42.6"/>
                    <measurement group_id="O3" value="-17.7" spread="18.8"/>
                    <measurement group_id="O4" value="-14.0" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.87</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over the course of 12months.</time_frame>
      <desc>Patients were approached and asked about any adverse events at regular study and/or clinic visits.</desc>
      <group_list>
        <group group_id="E1">
          <title>Kenalog or Placebo</title>
          <description>Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.&#xD;
Kenalog or placebo</description>
        </group>
        <group group_id="E2">
          <title>Kenalog Then Placebo</title>
          <description>Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.&#xD;
Kenalog then Placebo</description>
        </group>
        <group group_id="E3">
          <title>Kenalog Only</title>
          <description>Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®&#xD;
Kenalog</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea or Hives/Rash from post op pain meds</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Knee Effusion Post-Op</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Knee Effusion from Unanticipated Accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Arthrofibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nosebleed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Strep Throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Persistent Low Leg Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Stitch Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ACL Re-Tear</sub_title>
                <description>Re-Tear of the anterior cruciate ligament</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cervical Strain after Motor Vehicle Accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Infrapatella scarring/pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Cale Jacobs, ATC, PhD</name_or_title>
      <organization>Univerisity of Kentucky</organization>
      <phone>8592183065</phone>
      <email>Kycartilagedoc@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT01692756
org study id: 12-0706
nct id: NCT01692756
lead sponsor: 
collaborator: 
has dmc: Yes
This research study is the first of its kind and will allow health care professionals and
      researchers to answer many questions about the reasons why anterior cruciate ligament (ACL)
      injury leads to knee pain and disability and osteoarthritis. We also hope that this study
      will be the beginning of new, more powerful and safer drugs to help patients with ACL
      injuries heal sooner and return to sports or daily activities pain free. Study participants
      will be recruited from the University of Kentucky and Vanderbilt University.

      The purpose of this research is to gather information on how safe and effective Kenalog® is
      in alleviating knee pain following ACL rupture.
Injury to the knee during sports participation often involves partial of full detachment of
      the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation
      usually goes away in time, individuals with ACL injuries may experience pain and notice knee
      instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the
      joint, allowing individuals the ability to walk or run again pain free or participate in
      sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can
      occur in that same knee 10-20 years later for reasons which are not well understood.

      In this research study, we hope to prevent and reduce the initial post-operative pain. The
      reduction of pain will allow for earlier movement of the knee joint and preparation for
      surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL
      injuries by treating them within 1-2 days after their injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Participant Pain Assessment
time frame: Up to seven days
description: Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Efficacy of Kenalog to Alleviate Knee Pain
time frame: Up to seven days
description: The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).
measure: Synovial Interleukin-1α (IL-1α) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial Interleukin-1β (IL-1β) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial C-terminal Peptide II (CTXII) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial Glycosaminoglycans (GAG) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
measure: Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration
time frame: Up to seven days
description: Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
arm group label: Kenalog or Placebo
arm group type: Experimental
description: Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.
arm group label: Kenalog then placebo
arm group type: Experimental
description: Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.
arm group label: Kenalog only
arm group type: Experimental
description: Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®
arm group label: Placebo
arm group type: Placebo Comparator
description: subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.
intervention type: Drug
intervention name: Kenalog or placebo
arm group label: Kenalog or Placebo
other name: Drug: Kenalog
other name: Other Names:
other name: triamcinolone acetonide injectable suspension
other name: Drug Placebo (for Kenalog)
other name: physiologic Saline solution
intervention type: Drug
intervention name: Kenalog then Placebo
arm group label: Kenalog then placebo
other name: Drug: Kenalog
other name: Other Names:
other name: triamcinolone acetonide injectable suspension
other name: Drug Placebo (for Kenalog)
other name: physiologic saline solution
intervention type: Drug
intervention name: Kenalog
arm group label: Kenalog only
other name: Drug: Kenalog
other name: Other Names:
other name: triamcinolone acetonide injectable suspension
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
other name: Drug Placebo (for Kenalog)
other name: physiologic saline solution
criteria: 
gender: All
minimum age: 14 Years
maximum age: 33 Years
healthy volunteers: No
last name: Christian Lattermann, MD
role: Principal Investigator
affiliation: University of Kentucky, Department of Orthopaedic Surgery
facility: 
country: United States
citation: Lattermann C, Jacobs CA, Proffitt Bunnell M, Huston LJ, Gammon LG, Johnson DL, Reinke EK, Huebner JL, Kraus VB, Spindler KP. A Multicenter Study of Early Anti-inflammatory Treatment in Patients With Acute Anterior Cruciate Ligament Tear. Am J Sports Med. 2017 Feb;45(2):325-333. doi: 10.1177/0363546516666818. Epub 2016 Oct 7.
PMID: 28146402
citation: Lattermann C, Jacobs CA, Bunnell MP, Jochimsen KN, Abt JP, Reinke EK, Gammon LG, Huebner JL, Kraus VB, Spindler KP. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res. 2017 Mar;35(3):641-650. doi: 10.1002/jor.23329. Epub 2016 Jun 30.
PMID: 27279368
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Cale Jacobs
investigator title: Sponsor/Investigator
mesh term: Anterior Cruciate Ligament Injuries
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Pharmaceutical Solutions
mesh term: Triamcinolone diacetate
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 