<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/NCT03236155</url>
  </required_header>
  <id_info>
    <org_study_id>17030306</org_study_id>
    <nct_id>NCT03236155</nct_id>
  </id_info>
  <brief_title>Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients</brief_title>
  <official_title>Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The United States constitutes &lt;5% of the world's population but over 80% of the opioid supply&#xD;
      and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug&#xD;
      overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids.&#xD;
      Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood&#xD;
      of readmission for pain. Available data suggests that orthopaedic surgeons are the most&#xD;
      likely physicians to prescribe opioids to Medicare patients, whose opioid prescriptions are&#xD;
      over 7 times more likely to come from an orthopaedic surgeon than another type of physician,&#xD;
      but orthopaedic surgeons also had the highest readmission rate for post-operative pain. Many&#xD;
      studies have investigated the utilization of opioids after surgery to assess surgeon's&#xD;
      tendencies to overprescribe, demographics of those likely to overuse, and adverse events of&#xD;
      opioid abusers.&#xD;
&#xD;
      The primary purpose of this randomized controlled trial is to determine whether prescribing&#xD;
      fewer opioid pills per prescription reduces the total amount of opioids taken, even while&#xD;
      allowing equal total opioid availability via increased frequency of prescription&#xD;
      availability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A recent paper by Kim et al prospectively investigated opioid utilization after upper&#xD;
      extremity surgery. This study (n=1,416) showed an opioid utilization rate of just 34%, taking&#xD;
      an average 8.1 pills out of 24 prescribed. Patients age 30-39, those having joint procedures,&#xD;
      upper extremity/shoulder surgery, or self-pay/Medicaid insurance were all far more likely to&#xD;
      overuse opioids. The study concluded that their surgeons prescribed 3 times the required&#xD;
      opioid following surgery and gave recommendations for opioid distribution based on location,&#xD;
      procedure type, and patient risk factors. This study's identification of over prescription is&#xD;
      congruent with a study completed by Bates et al that showed 67% of patients had a surplus of&#xD;
      medications, with 92% not receiving proper medication disposal instructions.&#xD;
&#xD;
      Other recent literature has attempted to risk stratify patients who are more likely to abuse&#xD;
      prescription opioids. Morris et al identified various risk factors including: family history&#xD;
      of substance abuse, nicotine dependency, age &lt;45, psychiatric disorders, and lower level of&#xD;
      education. These risk factors are associated with aberrant behaviors (non-compliance, early&#xD;
      refill request, &quot;lost or stolen&quot; medication), which should raise concerns for any provider&#xD;
      prescribing opioids.&#xD;
&#xD;
      Studies have shown that patients who are on chronic opioid therapy before surgery have worse&#xD;
      outcomes. Nicholas Bedard et al compared chronic opioids users (n= 35,068) versus those who&#xD;
      were opioid-naïve at the time of total knee arthroplasty (TKA) and found the opioid group&#xD;
      had more opioid scripts filled per patient at discharge as well as at 3, 6, and 9 months&#xD;
      (0.63 scripts/patient vs. 1.2 scripts/patient, p&lt;0.05). These patients also had a higher&#xD;
      Charlson Comorbidity Index (p&lt;0.05) and higher rates of respiratory failure, acute kidney&#xD;
      failure, pneumonia, all post-operative infections, and infections requiring return to the OR.&#xD;
      The study concluded patients should have their opioid consumption controlled during the&#xD;
      pre-operative and peri-operative period.&#xD;
&#xD;
      In addition to the complications of opioid medications experienced by orthopaedic patients, a&#xD;
      recent nationwide retrospective analysis presents an unintended yet severe problem associated&#xD;
      with opioid prescriptions. The incidence of pediatric hospitalizations for opioid toxicity&#xD;
      nearly tripled from 1997 to 2012. The over-prescription of opioids creates a readily&#xD;
      available source for accidental ingestion by younger children and for intentional opioid&#xD;
      overdose by older pediatric/adolescent patients. In fact, a family member's leftover pills&#xD;
      have been described as the number one source for pediatric opioid overdose. Moreover, the&#xD;
      Center for Disease Control reported that in 2015 the U.S. saw its highest incidence of&#xD;
      opioid-related death.9 Given the frequency and severity of opioid diversion and misuse,&#xD;
      orthopaedic surgeons should consider the best methods for controlling patients postoperative&#xD;
      pain and also avoid facilitating opiate misuse, whether by orthopaedic patients or other&#xD;
      community members. With this goal in mind, our study will investigate regimens for effective&#xD;
      postoperative pain control that also minimize the total amount of opioids prescribed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">August 26, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient</measure>
    <time_frame>30 days</time_frame>
    <description>Self-reported by patient, we are asking for the number of Oxycodone taken by patients (5mg doses). This will be verified with patient bringing their pill bottle in and counted by a study investigator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018</measure>
    <time_frame>90 days post operative (higher values represent better functioning total hip or total knee replacements).</time_frame>
    <description>Postoperative total hip and total knee arthroplasty patient reported outcomes at 90 days (All reported as scores on a scale, ranges below.). For hips: Hip Disability and Osteoarthritis Outcome Score Joint Replacement (Hoos Jr), for knees: Knee Injury and Osteoarthritis Outcome Score, Joint Replacement, (Koos Jr), additionally, all will complete the Veterans Rand-12 outcome (VR-12). All outcomes, closer to 100 are better outcomes.&#xD;
HOOS, JR: Questions coded 0 - 4 points, none - extreme pain, scored by summing responses (range 0-24), convert to t-score. Answer ranges 0 - 100 (0 - total hip disability, 100 -perfect hip health).&#xD;
KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental/physical, measure in standard deviations out of 100 points, where a score of 100 shows a patient's health functioning physically and mentally at their their best, zero represents a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>90 days from time of surgery</time_frame>
    <description>Complications will be recorded as follows post-operatively for 90 days following surgery; any patient that has a DVT/Pulmonary embolism, any return to the operating room within 90-days, any re-admission to the hospital within 90-days, Any report of superficial infection, any report of deep infection, a periprosthetic fracture of the joint replaced, cerebrovascular accident or transient ischemic attack, report of dislocation, or patients who report opioid withdrawal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>90 days</time_frame>
    <description>This will be done as monitored through the Illinois prescription monitoring program, collecting data on each patient enrolled to be sure that patients do not receive additional narcotic prescriptions beyond what is provided to them as part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative Patient Reported Outcomes</measure>
    <time_frame>10 days prior to surgery (higher values represent better functioning total hip or total knee replacements).</time_frame>
    <description>Utilizing Preop Koos Jr, Preop Hoos Jr, and Pre operative VR-12, all subjects will be asked to provide a pre-operative patient reported outcome to compare to post-operative patient reported outcomes. All reported as scores on a scale, ranges below.&#xD;
HOOS, JR: Questions coded 0 to 4 points, none to extreme pain, scored by summing responses (range of 0-24), convert to interval score ranges 0 to 100 (0 - total hip disability, 100 -perfect hip health).&#xD;
KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Outpatient Pain Scores</measure>
    <time_frame>Days 1-3, 1 week, 2 weeks, and 3-4 weeks post discharge from surgery</time_frame>
    <description>Utilizing the defense &amp; veterans pain rating scale, patients enrolled will be asked at multiple time points after surgery regarding their pain. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Inpatient Opioid Utilization</measure>
    <time_frame>from time of surgery to discharge from hospital (1 day - 2 weeks)</time_frame>
    <description>Using the primary outcome of number of opioids taken by the patients while inpatient, those will be converted into morphine equivalents. This was obtained from the hospital chart during the patient's inpatient stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Inpatient Pain Scores</measure>
    <time_frame>assessed daily from time of surgery to discharge from hospital (1 days - 2 weeks), Day 14 scores reported</time_frame>
    <description>Using a Defense and Veterans Pain Rating scale, patients were asked from date of surgery to the date of discharge for daily inpatient pain scores. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Tablets Received From Pharmacy That Went Unused</measure>
    <time_frame>90 days</time_frame>
    <description>304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018, reporting number of pills not used&#xD;
Illinois prescription monitoring program- utilized to confirm no other physician prescribed opiates to the participating patients. They were asked at each visit regarding unused medications and brought to the office to properly dispose.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">304</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>1 prescription</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receives 90 pills in single prescription at discharge from hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 prescriptions</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>opioid pain pills</intervention_name>
    <description>patient will receive their pain pill prescription</description>
    <arm_group_label>1 prescription</arm_group_label>
    <arm_group_label>3 prescriptions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient &gt; 18 years of age scheduled for primary total hip or knee arthroplasty who&#xD;
             is not consuming opioids during the 4 weeks prior to surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients consuming opioids during the 4 weeks prior to surgery&#xD;
&#xD;
          -  patients who are allergic to oxycodone or refuse to take oxycodone&#xD;
&#xD;
          -  patients with a history of opioid dependence or illegal or &quot;off-label&quot; opioid use&#xD;
&#xD;
          -  patients undergoing a revision total knee or total hip arthroplasty&#xD;
&#xD;
          -  any patient less than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.</citation>
    <PMID>27869630</PMID>
  </reference>
  <reference>
    <citation>Opioid Addiction 2016 Facts &amp; Figures. American Society of Addiction Medicine. Retrieved from: http://www.asam.org/docs/default-source/advocacy/opioidaddiction-disease-facts-figures.pdf</citation>
  </reference>
  <reference>
    <citation>Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.</citation>
    <PMID>25911660</PMID>
  </reference>
  <reference>
    <citation>Bedard Nicholas, Callaghan John, Pugely Andrew, Martin Christopher, Duchman Kyle, Westermann Robert, Gao Yubo. Pre-Opioid Use: Is There an Association with Outcomes Following Total Knee Arthroplasty? In: American Academy of Orthopaedic Surgeons 2016 Annual Meeting; 2016 Mar 1-5; Orlando, FL. Presentation nr P161</citation>
  </reference>
  <reference>
    <citation>Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.</citation>
    <PMID>21168869</PMID>
  </reference>
  <reference>
    <citation>Opioid Use, Misuse, and Abuse in Orthopaedic Practice. American Academy of Orthopaedic Surgeons. October 2015. Retrieved from: http://www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/adv istmt/1045%20Opioid%20Use,%20Misuse,%20and%20Abuse%20in%20Practice .pdf</citation>
  </reference>
  <reference>
    <citation>Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.</citation>
    <PMID>27802492</PMID>
  </reference>
  <reference>
    <citation>Moreno MA. Page for patients. The misuse of prescription pain medicine among children and teens. JAMA Pediatr. 2015 May;169(5):512. doi: 10.1001/jamapediatrics.2014.2128. No abstract available. Erratum In: JAMA Pediatr. 2015 Jul;169(7):699.</citation>
    <PMID>25938654</PMID>
  </reference>
  <reference>
    <citation>Retrieved on 12/9/16 from: https://www.whitehouse.gov/the-pressoffice/2016/12/08/continued-rise-opioid-overdose-deaths-2015-shows-urgentneed-treatment</citation>
  </reference>
  <reference>
    <citation>Della Valle CJ, Dittle E, Moric M, Sporer SM, Buvanendran A. A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty. Clin Orthop Relat Res. 2010 Dec;468(12):3348-54. doi: 10.1007/s11999-010-1491-5. Epub 2010 Jul 29.</citation>
    <PMID>20668969</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>October 14, 2021</results_first_submitted>
  <results_first_submitted_qc>June 28, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 20, 2023</results_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Craig J Della Valle, MD</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Opioids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03236155/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>1 Prescription</title>
          <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
        </group>
        <group group_id="P2">
          <title>3 Prescriptions</title>
          <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Minimum Age: 18 Years Maximum Age: none Sex: All Gender Based: No Ethnicity Based: no</population>
      <group_list>
        <group group_id="B1">
          <title>1 Prescription</title>
          <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
        </group>
        <group group_id="B2">
          <title>3 Prescriptions</title>
          <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
        </group>
        <group group_id="B3">
          <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="143"/>
            <count group_id="B2" value="161"/>
            <count group_id="B3" value="304"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="143"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="304"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="151"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="143"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="304"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="143"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="304"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="161"/>
                    <measurement group_id="B3" value="304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient</title>
        <description>Self-reported by patient, we are asking for the number of Oxycodone taken by patients (5mg doses). This will be verified with patient bringing their pill bottle in and counted by a study investigator.</description>
        <time_frame>30 days</time_frame>
        <population>Opioid naive patients undergoing THA or TKA between August 2017 and April 2018 and Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient</population>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital. Two refills available</description>
          </group>
        </group_list>
        <measure>
          <title>Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient</title>
          <description>Self-reported by patient, we are asking for the number of Oxycodone taken by patients (5mg doses). This will be verified with patient bringing their pill bottle in and counted by a study investigator.</description>
          <population>Opioid naive patients undergoing THA or TKA between August 2017 and April 2018 and Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient</population>
          <units>Morphine Milligram Equivalents (MME)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1089.7" spread="536.4"/>
                    <measurement group_id="O2" value="777.1" spread="414.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018</title>
        <description>Postoperative total hip and total knee arthroplasty patient reported outcomes at 90 days (All reported as scores on a scale, ranges below.). For hips: Hip Disability and Osteoarthritis Outcome Score Joint Replacement (Hoos Jr), for knees: Knee Injury and Osteoarthritis Outcome Score, Joint Replacement, (Koos Jr), additionally, all will complete the Veterans Rand-12 outcome (VR-12). All outcomes, closer to 100 are better outcomes.&#xD;
HOOS, JR: Questions coded 0 - 4 points, none - extreme pain, scored by summing responses (range 0-24), convert to t-score. Answer ranges 0 - 100 (0 - total hip disability, 100 -perfect hip health).&#xD;
KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental/physical, measure in standard deviations out of 100 points, where a score of 100 shows a patient's health functioning physically and mentally at their their best, zero represents a worse outcome.</description>
        <time_frame>90 days post operative (higher values represent better functioning total hip or total knee replacements).</time_frame>
        <population>Scores closer to 100 are considered better outcomes</population>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018</title>
          <description>Postoperative total hip and total knee arthroplasty patient reported outcomes at 90 days (All reported as scores on a scale, ranges below.). For hips: Hip Disability and Osteoarthritis Outcome Score Joint Replacement (Hoos Jr), for knees: Knee Injury and Osteoarthritis Outcome Score, Joint Replacement, (Koos Jr), additionally, all will complete the Veterans Rand-12 outcome (VR-12). All outcomes, closer to 100 are better outcomes.&#xD;
HOOS, JR: Questions coded 0 - 4 points, none - extreme pain, scored by summing responses (range 0-24), convert to t-score. Answer ranges 0 - 100 (0 - total hip disability, 100 -perfect hip health).&#xD;
KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental/physical, measure in standard deviations out of 100 points, where a score of 100 shows a patient's health functioning physically and mentally at their their best, zero represents a worse outcome.</description>
          <population>Scores closer to 100 are considered better outcomes</population>
          <units>score 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="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Postop Koos Jr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.9" spread="9.9"/>
                    <measurement group_id="O2" value="65.0" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postop Hoos Jr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.5" spread="13.8"/>
                    <measurement group_id="O2" value="73.7" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postop VR-12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.2" spread="14.7"/>
                    <measurement group_id="O2" value="92.1" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complications</title>
        <description>Complications will be recorded as follows post-operatively for 90 days following surgery; any patient that has a DVT/Pulmonary embolism, any return to the operating room within 90-days, any re-admission to the hospital within 90-days, Any report of superficial infection, any report of deep infection, a periprosthetic fracture of the joint replaced, cerebrovascular accident or transient ischemic attack, report of dislocation, or patients who report opioid withdrawal.</description>
        <time_frame>90 days from time of surgery</time_frame>
        <population>304 opioid naive patients undergoing total hip or total knee arthroplasties</population>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
        </group_list>
        <measure>
          <title>Complications</title>
          <description>Complications will be recorded as follows post-operatively for 90 days following surgery; any patient that has a DVT/Pulmonary embolism, any return to the operating room within 90-days, any re-admission to the hospital within 90-days, Any report of superficial infection, any report of deep infection, a periprosthetic fracture of the joint replaced, cerebrovascular accident or transient ischemic attack, report of dislocation, or patients who report opioid withdrawal.</description>
          <population>304 opioid naive patients undergoing total hip or total knee arthroplasties</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Compliance</title>
        <description>This will be done as monitored through the Illinois prescription monitoring program, collecting data on each patient enrolled to be sure that patients do not receive additional narcotic prescriptions beyond what is provided to them as part of the study.</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
        </group_list>
        <measure>
          <title>Compliance</title>
          <description>This will be done as monitored through the Illinois prescription monitoring program, collecting data on each patient enrolled to be sure that patients do not receive additional narcotic prescriptions beyond what is provided to them as part of the study.</description>
          <units>Number of Compliant Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preoperative Patient Reported Outcomes</title>
        <description>Utilizing Preop Koos Jr, Preop Hoos Jr, and Pre operative VR-12, all subjects will be asked to provide a pre-operative patient reported outcome to compare to post-operative patient reported outcomes. All reported as scores on a scale, ranges below.&#xD;
HOOS, JR: Questions coded 0 to 4 points, none to extreme pain, scored by summing responses (range of 0-24), convert to interval score ranges 0 to 100 (0 - total hip disability, 100 -perfect hip health).&#xD;
KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome.</description>
        <time_frame>10 days prior to surgery (higher values represent better functioning total hip or total knee replacements).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
        </group_list>
        <measure>
          <title>Preoperative Patient Reported Outcomes</title>
          <description>Utilizing Preop Koos Jr, Preop Hoos Jr, and Pre operative VR-12, all subjects will be asked to provide a pre-operative patient reported outcome to compare to post-operative patient reported outcomes. All reported as scores on a scale, ranges below.&#xD;
HOOS, JR: Questions coded 0 to 4 points, none to extreme pain, scored by summing responses (range of 0-24), convert to interval score ranges 0 to 100 (0 - total hip disability, 100 -perfect hip health).&#xD;
KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome.</description>
          <units>score 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="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Preop Koos Jr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.3" spread="12.5"/>
                    <measurement group_id="O2" value="51.5" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preop Hoos Jr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.2" spread="16.3"/>
                    <measurement group_id="O2" value="50.7" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preop VR-12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.8" spread="14.6"/>
                    <measurement group_id="O2" value="89.1" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Outpatient Pain Scores</title>
        <description>Utilizing the defense &amp; veterans pain rating scale, patients enrolled will be asked at multiple time points after surgery regarding their pain. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.</description>
        <time_frame>Days 1-3, 1 week, 2 weeks, and 3-4 weeks post discharge from surgery</time_frame>
        <population>304 opioid naïve patients undergoing THA or TKA, assessed daily from time of surgery to discharge from hospital (1 days - 4 weeks), Reported at 1-3 days, 1 week after surgery, 2 weeks after surgery, and 3-4 weeks after surgery (dependent on follow up appointment).</population>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Outpatient Pain Scores</title>
          <description>Utilizing the defense &amp; veterans pain rating scale, patients enrolled will be asked at multiple time points after surgery regarding their pain. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.</description>
          <population>304 opioid naïve patients undergoing THA or TKA, assessed daily from time of surgery to discharge from hospital (1 days - 4 weeks), Reported at 1-3 days, 1 week after surgery, 2 weeks after surgery, and 3-4 weeks after surgery (dependent on follow up appointment).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Days 1-3 after discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.3" lower_limit="0" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 after discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="0.4" upper_limit="10"/>
                    <measurement group_id="O2" value="4.1" lower_limit="0.3" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 after discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="0" upper_limit="9.6"/>
                    <measurement group_id="O2" value="3.1" lower_limit="0" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weeks 3-4 after discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="0" upper_limit="8.4"/>
                    <measurement group_id="O2" value="2.2" lower_limit="0" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Inpatient Opioid Utilization</title>
        <description>Using the primary outcome of number of opioids taken by the patients while inpatient, those will be converted into morphine equivalents. This was obtained from the hospital chart during the patient's inpatient stay.</description>
        <time_frame>from time of surgery to discharge from hospital (1 day - 2 weeks)</time_frame>
        <population>304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018</population>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5 mg OxyIR) Pills Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Inpatient Opioid Utilization</title>
          <description>Using the primary outcome of number of opioids taken by the patients while inpatient, those will be converted into morphine equivalents. This was obtained from the hospital chart during the patient's inpatient stay.</description>
          <population>304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018</population>
          <units>Morphine Equivalent while inpatient</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.6" spread="38.9"/>
                    <measurement group_id="O2" value="72.2" spread="55.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Inpatient Pain Scores</title>
        <description>Using a Defense and Veterans Pain Rating scale, patients were asked from date of surgery to the date of discharge for daily inpatient pain scores. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.</description>
        <time_frame>assessed daily from time of surgery to discharge from hospital (1 days - 2 weeks), Day 14 scores reported</time_frame>
        <population>304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018</population>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5mg OxyIR) Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Inpatient Pain Scores</title>
          <description>Using a Defense and Veterans Pain Rating scale, patients were asked from date of surgery to the date of discharge for daily inpatient pain scores. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.</description>
          <population>304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="0" upper_limit="8.7"/>
                    <measurement group_id="O2" value="4.5" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Tablets Received From Pharmacy That Went Unused</title>
        <description>304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018, reporting number of pills not used&#xD;
Illinois prescription monitoring program- utilized to confirm no other physician prescribed opiates to the participating patients. They were asked at each visit regarding unused medications and brought to the office to properly dispose.</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>90 (5mg OxyIR) Pills Prescribed</title>
            <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
          <group group_id="O2">
            <title>30 (5mg OxyIR) Prescribed</title>
            <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Tablets Received From Pharmacy That Went Unused</title>
          <description>304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018, reporting number of pills not used&#xD;
Illinois prescription monitoring program- utilized to confirm no other physician prescribed opiates to the participating patients. They were asked at each visit regarding unused medications and brought to the office to properly dispose.</description>
          <units>Unused pills</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" lower_limit="0" upper_limit="90"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>304 opioid naïve patients following their THA or TKA for 90 days, for surgeries between August 2017 and April 2018 agreed to participate and were randomized to two groups: 30 or 90 5-mg oxycodone immediate release (OxyIR) pills after discharge.</time_frame>
      <desc>no difference in definition.</desc>
      <group_list>
        <group group_id="E1">
          <title>90 (5mg OxyIR) Pills Prescribed</title>
          <description>Receives 90 pills in single prescription at discharge from hospital&#xD;
opioid pain pills: patient will receive their pain pill prescription</description>
        </group>
        <group group_id="E2">
          <title>30 (5mg OxyIR) Pills Prescribed</title>
          <description>Receives 30 pill prescription at discharge from hospital. Two refills available if requested.&#xD;
opioid pain pills: patient will receive their pain pill prescription</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="143"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Anne DeBenedetti, CRC</name_or_title>
      <organization>Rush University Medical Center</organization>
      <phone>3124322468</phone>
      <email>anne.debenedetti@rushortho.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/NCT03236155
org study id: 17030306
nct id: NCT03236155
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The United States constitutes <5% of the world's population but over 80% of the opioid supply
      and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug
      overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids.
      Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood
      of readmission for pain. Available data suggests that orthopaedic surgeons are the most
      likely physicians to prescribe opioids to Medicare patients, whose opioid prescriptions are
      over 7 times more likely to come from an orthopaedic surgeon than another type of physician,
      but orthopaedic surgeons also had the highest readmission rate for post-operative pain. Many
      studies have investigated the utilization of opioids after surgery to assess surgeon's
      tendencies to overprescribe, demographics of those likely to overuse, and adverse events of
      opioid abusers.

      The primary purpose of this randomized controlled trial is to determine whether prescribing
      fewer opioid pills per prescription reduces the total amount of opioids taken, even while
      allowing equal total opioid availability via increased frequency of prescription
      availability.
A recent paper by Kim et al prospectively investigated opioid utilization after upper
      extremity surgery. This study (n=1,416) showed an opioid utilization rate of just 34%, taking
      an average 8.1 pills out of 24 prescribed. Patients age 30-39, those having joint procedures,
      upper extremity/shoulder surgery, or self-pay/Medicaid insurance were all far more likely to
      overuse opioids. The study concluded that their surgeons prescribed 3 times the required
      opioid following surgery and gave recommendations for opioid distribution based on location,
      procedure type, and patient risk factors. This study's identification of over prescription is
      congruent with a study completed by Bates et al that showed 67% of patients had a surplus of
      medications, with 92% not receiving proper medication disposal instructions.

      Other recent literature has attempted to risk stratify patients who are more likely to abuse
      prescription opioids. Morris et al identified various risk factors including: family history
      of substance abuse, nicotine dependency, age <45, psychiatric disorders, and lower level of
      education. These risk factors are associated with aberrant behaviors (non-compliance, early
      refill request, "lost or stolen" medication), which should raise concerns for any provider
      prescribing opioids.

      Studies have shown that patients who are on chronic opioid therapy before surgery have worse
      outcomes. Nicholas Bedard et al compared chronic opioids users (n= 35,068) versus those who
      were opioid-naïve at the time of total knee arthroplasty (TKA) and found the opioid group
      had more opioid scripts filled per patient at discharge as well as at 3, 6, and 9 months
      (0.63 scripts/patient vs. 1.2 scripts/patient, p<0.05). These patients also had a higher
      Charlson Comorbidity Index (p<0.05) and higher rates of respiratory failure, acute kidney
      failure, pneumonia, all post-operative infections, and infections requiring return to the OR.
      The study concluded patients should have their opioid consumption controlled during the
      pre-operative and peri-operative period.

      In addition to the complications of opioid medications experienced by orthopaedic patients, a
      recent nationwide retrospective analysis presents an unintended yet severe problem associated
      with opioid prescriptions. The incidence of pediatric hospitalizations for opioid toxicity
      nearly tripled from 1997 to 2012. The over-prescription of opioids creates a readily
      available source for accidental ingestion by younger children and for intentional opioid
      overdose by older pediatric/adolescent patients. In fact, a family member's leftover pills
      have been described as the number one source for pediatric opioid overdose. Moreover, the
      Center for Disease Control reported that in 2015 the U.S. saw its highest incidence of
      opioid-related death.9 Given the frequency and severity of opioid diversion and misuse,
      orthopaedic surgeons should consider the best methods for controlling patients postoperative
      pain and also avoid facilitating opiate misuse, whether by orthopaedic patients or other
      community members. With this goal in mind, our study will investigate regimens for effective
      postoperative pain control that also minimize the total amount of opioids prescribed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient
time frame: 30 days
description: Self-reported by patient, we are asking for the number of Oxycodone taken by patients (5mg doses). This will be verified with patient bringing their pill bottle in and counted by a study investigator.
measure: Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018
time frame: 90 days post operative (higher values represent better functioning total hip or total knee replacements).
description: Postoperative total hip and total knee arthroplasty patient reported outcomes at 90 days (All reported as scores on a scale, ranges below.). For hips: Hip Disability and Osteoarthritis Outcome Score Joint Replacement (Hoos Jr), for knees: Knee Injury and Osteoarthritis Outcome Score, Joint Replacement, (Koos Jr), additionally, all will complete the Veterans Rand-12 outcome (VR-12). All outcomes, closer to 100 are better outcomes.
HOOS, JR: Questions coded 0 - 4 points, none - extreme pain, scored by summing responses (range 0-24), convert to t-score. Answer ranges 0 - 100 (0 - total hip disability, 100 -perfect hip health).
KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental/physical, measure in standard deviations out of 100 points, where a score of 100 shows a patient's health functioning physically and mentally at their their best, zero represents a worse outcome.
measure: Complications
time frame: 90 days from time of surgery
description: Complications will be recorded as follows post-operatively for 90 days following surgery; any patient that has a DVT/Pulmonary embolism, any return to the operating room within 90-days, any re-admission to the hospital within 90-days, Any report of superficial infection, any report of deep infection, a periprosthetic fracture of the joint replaced, cerebrovascular accident or transient ischemic attack, report of dislocation, or patients who report opioid withdrawal.
measure: Compliance
time frame: 90 days
description: This will be done as monitored through the Illinois prescription monitoring program, collecting data on each patient enrolled to be sure that patients do not receive additional narcotic prescriptions beyond what is provided to them as part of the study.
measure: Preoperative Patient Reported Outcomes
time frame: 10 days prior to surgery (higher values represent better functioning total hip or total knee replacements).
description: Utilizing Preop Koos Jr, Preop Hoos Jr, and Pre operative VR-12, all subjects will be asked to provide a pre-operative patient reported outcome to compare to post-operative patient reported outcomes. All reported as scores on a scale, ranges below.
HOOS, JR: Questions coded 0 to 4 points, none to extreme pain, scored by summing responses (range of 0-24), convert to interval score ranges 0 to 100 (0 - total hip disability, 100 -perfect hip health).
KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome.
measure: Postoperative Outpatient Pain Scores
time frame: Days 1-3, 1 week, 2 weeks, and 3-4 weeks post discharge from surgery
description: Utilizing the defense & veterans pain rating scale, patients enrolled will be asked at multiple time points after surgery regarding their pain. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.
measure: Postoperative Inpatient Opioid Utilization
time frame: from time of surgery to discharge from hospital (1 day - 2 weeks)
description: Using the primary outcome of number of opioids taken by the patients while inpatient, those will be converted into morphine equivalents. This was obtained from the hospital chart during the patient's inpatient stay.
measure: Postoperative Inpatient Pain Scores
time frame: assessed daily from time of surgery to discharge from hospital (1 days - 2 weeks), Day 14 scores reported
description: Using a Defense and Veterans Pain Rating scale, patients were asked from date of surgery to the date of discharge for daily inpatient pain scores. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.
measure: Number of Tablets Received From Pharmacy That Went Unused
time frame: 90 days
description: 304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018, reporting number of pills not used
Illinois prescription monitoring program- utilized to confirm no other physician prescribed opiates to the participating patients. They were asked at each visit regarding unused medications and brought to the office to properly dispose.
arm group label: 1 prescription
arm group type: Active Comparator
description: Receives 90 pills in single prescription at discharge from hospital
arm group label: 3 prescriptions
arm group type: Active Comparator
description: Receives 30 pill prescription at discharge from hospital. Two refills available if requested.
intervention type: Drug
intervention name: opioid pain pills
description: patient will receive their pain pill prescription
arm group label: 1 prescription
arm group label: 3 prescriptions
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.
PMID: 27869630
citation: Opioid Addiction 2016 Facts & Figures. American Society of Addiction Medicine. Retrieved from: http://www.asam.org/docs/default-source/advocacy/opioidaddiction-disease-facts-figures.pdf
citation: Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
PMID: 25911660
citation: Bedard Nicholas, Callaghan John, Pugely Andrew, Martin Christopher, Duchman Kyle, Westermann Robert, Gao Yubo. Pre-Opioid Use: Is There an Association with Outcomes Following Total Knee Arthroplasty? In: American Academy of Orthopaedic Surgeons 2016 Annual Meeting; 2016 Mar 1-5; Orlando, FL. Presentation nr P161
citation: Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.
PMID: 21168869
citation: Opioid Use, Misuse, and Abuse in Orthopaedic Practice. American Academy of Orthopaedic Surgeons. October 2015. Retrieved from: http://www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/adv istmt/1045%20Opioid%20Use,%20Misuse,%20and%20Abuse%20in%20Practice .pdf
citation: Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.
PMID: 27802492
citation: Moreno MA. Page for patients. The misuse of prescription pain medicine among children and teens. JAMA Pediatr. 2015 May;169(5):512. doi: 10.1001/jamapediatrics.2014.2128. No abstract available. Erratum In: JAMA Pediatr. 2015 Jul;169(7):699.
PMID: 25938654
citation: Retrieved on 12/9/16 from: https://www.whitehouse.gov/the-pressoffice/2016/12/08/continued-rise-opioid-overdose-deaths-2015-shows-urgentneed-treatment
citation: Della Valle CJ, Dittle E, Moric M, Sporer SM, Buvanendran A. A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty. Clin Orthop Relat Res. 2010 Dec;468(12):3348-54. doi: 10.1007/s11999-010-1491-5. Epub 2010 Jul 29.
PMID: 20668969
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Craig J Della Valle, MD
investigator title: Attending Physician
mesh term: Pain, Postoperative
mesh term: Analgesics, Opioid
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 