<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/NCT03807349</url>
  </required_header>
  <id_info>
    <org_study_id>CMU2017-60T</org_study_id>
    <nct_id>NCT03807349</nct_id>
  </id_info>
  <brief_title>N-Force Screws Augmented With N-Force Blue in Hip Fractures</brief_title>
  <acronym>N-Force</acronym>
  <official_title>N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zimmer Biomet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this prospective study is to confirm safety and performance of N-Force&#xD;
      Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Endpoint:&#xD;
&#xD;
      • Re-operation within 12 months after initial surgery to promote fracture healing, relieve&#xD;
      pain, treat infection, or improve function.&#xD;
&#xD;
      Secondary Endpoints:&#xD;
&#xD;
        -  Radiographic and clinical fracture healing of the proximal femur using standard scoring&#xD;
           methods and patient satisfaction.&#xD;
&#xD;
        -  Cost effectiveness&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor will not pursue CE mark for this product, which precludes need for large PMCF study.&#xD;
  </why_stopped>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">March 11, 2021</completion_date>
  <primary_completion_date type="Actual">March 11, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With a Reoperation</measure>
    <time_frame>12 months</time_frame>
    <description>Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)</measure>
    <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
    <description>Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Steinberg Classification at 12 Months</measure>
    <time_frame>12 months</time_frame>
    <description>Steinberg Classification is based on the radiographic appearance and location of lesion. It is concise and delineates the progression and extent of Avascular Necrosis (AVN) involvement more accurately.&#xD;
[stage 0:] normal or non-diagnostic radiographs, MRI and bone scan of at risk hip (often contralateral hip involved, or patient has risk factors and hip pain) [stage I:] normal radiograph, abnormal bone scan and/or MRI [stage II:] cystic and sclerotic radiographic changes [stage III:] subchondral lucency or crescent sign [stage IV:] flattening of femoral head, with depression graded into mild: &lt;2 mm moderate: 2-4 mm severe: &gt;4 mm [stage V:] joint space narrowing with or without acetabular involvement [stage VI]: advanced degenerative changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)</measure>
    <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
    <description>The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)</measure>
    <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
    <description>The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.&#xD;
The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)</measure>
    <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
    <description>This will be measured using Harris Hip Score. This is quantified on a scale of 0-100 and the domains covered are pain, function, absence of deformity, and range of motion. The score is quantified on a scale of 0-100, with 100 points being the best possible outcome. The domains cover pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)</measure>
    <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
    <description>This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)</measure>
    <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
    <description>This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-Effective Analysis</measure>
    <time_frame>12 months</time_frame>
    <description>Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Intracapsular Proximal Femur Fracture</condition>
  <condition>Garden Grade I Subcapital Fracture of Femoral Neck</condition>
  <condition>Garden Grade II Subcapital Fracture of Femoral Neck</condition>
  <arm_group>
    <arm_group_label>N-Force Screws</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>N-Force Screws Augmented with N-Force Blue</intervention_name>
    <description>N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
    <arm_group_label>N-Force Screws</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has primary Garden I or II intracapsular proximal femur fracture requiring&#xD;
             surgical intervention and is eligible for fixation by three cannulated screws&#xD;
             augmented with N-Force Blue.&#xD;
&#xD;
          -  Patient receives operative treatment within 7 days of injury.&#xD;
&#xD;
          -  Patient was ambulatory before injury.&#xD;
&#xD;
          -  Patient is 50 years of age or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has Garden III or IV intracapsular proximal femur fracture.&#xD;
&#xD;
          -  Patient has major cognitive impairment (including dementia).&#xD;
&#xD;
          -  Patient is on dialysis.&#xD;
&#xD;
          -  Patient is not expected to survive follow-up schedule.&#xD;
&#xD;
          -  Patient is expected to have problems maintaining follow-up compliance, i.e. patients&#xD;
             with no fixed address, patients not mentally competent to give informed consent, etc.&#xD;
             (Investigator's discretion).&#xD;
&#xD;
          -  Patient is a prisoner.&#xD;
&#xD;
          -  Patient is known to be pregnant and/or breastfeeding.&#xD;
&#xD;
          -  Patient is a known alcohol or drug abuser.&#xD;
&#xD;
          -  Patient had previous/has active acute or chronic infections, especially at the site of&#xD;
             operation.&#xD;
&#xD;
          -  Patient has non-viable bone, or has areas where surrounding bone is not viable or&#xD;
             capable of supporting and anchoring the implant.&#xD;
&#xD;
          -  Patient has traumatic injuries with open wounds or close to the proximal femur&#xD;
             fracture, which are likely to become infected.&#xD;
&#xD;
          -  Patient is expected to be non-compliant with recommended post-operative weight-bearing&#xD;
             instructions.&#xD;
&#xD;
          -  Physical conditions, in the opinion of the investigator, that would prohibit adequate&#xD;
             implant support or impede healing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Boylan, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Zimmer Biomet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Donald B Slocum Research and Education Foundation</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>March 7, 2022</results_first_submitted>
  <results_first_submitted_qc>May 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 8, 2022</results_first_posted>
  <last_update_submitted>May 14, 2022</last_update_submitted>
  <last_update_submitted_qc>May 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cannulated Screws</keyword>
  <keyword>Augmentation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
  </condition_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>January 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03807349/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>N-Force Screws</title>
          <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Early Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>N-Force Screws</title>
          <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77" lower_limit="54" upper_limit="89"/>
                  </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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Reoperation</title>
        <description>Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Reoperation</title>
          <description>Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)</title>
        <description>Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).</description>
        <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
        <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)</title>
          <description>Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).</description>
          <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 weeks - RUSH Healing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months - RUSH Healing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months - RUSH Healing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months - RUSH Healing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Steinberg Classification at 12 Months</title>
        <description>Steinberg Classification is based on the radiographic appearance and location of lesion. It is concise and delineates the progression and extent of Avascular Necrosis (AVN) involvement more accurately.&#xD;
[stage 0:] normal or non-diagnostic radiographs, MRI and bone scan of at risk hip (often contralateral hip involved, or patient has risk factors and hip pain) [stage I:] normal radiograph, abnormal bone scan and/or MRI [stage II:] cystic and sclerotic radiographic changes [stage III:] subchondral lucency or crescent sign [stage IV:] flattening of femoral head, with depression graded into mild: &lt;2 mm moderate: 2-4 mm severe: &gt;4 mm [stage V:] joint space narrowing with or without acetabular involvement [stage VI]: advanced degenerative changes</description>
        <time_frame>12 months</time_frame>
        <population>At the time of early study termination, 12 subjects enrolled into the study. Steinberg classification is only measured for subjects that have completed their 12 month follow-up visit. Although 3 subjects completed the 12 month follow-up, Steinberg Classification is only available on 2 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Steinberg Classification at 12 Months</title>
          <description>Steinberg Classification is based on the radiographic appearance and location of lesion. It is concise and delineates the progression and extent of Avascular Necrosis (AVN) involvement more accurately.&#xD;
[stage 0:] normal or non-diagnostic radiographs, MRI and bone scan of at risk hip (often contralateral hip involved, or patient has risk factors and hip pain) [stage I:] normal radiograph, abnormal bone scan and/or MRI [stage II:] cystic and sclerotic radiographic changes [stage III:] subchondral lucency or crescent sign [stage IV:] flattening of femoral head, with depression graded into mild: &lt;2 mm moderate: 2-4 mm severe: &gt;4 mm [stage V:] joint space narrowing with or without acetabular involvement [stage VI]: advanced degenerative changes</description>
          <population>At the time of early study termination, 12 subjects enrolled into the study. Steinberg classification is only measured for subjects that have completed their 12 month follow-up visit. Although 3 subjects completed the 12 month follow-up, Steinberg Classification is only available on 2 subjects.</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stage 0: Normal radiographs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage VI: Advanced degenerative changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)</title>
        <description>The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.</description>
        <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
        <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)</title>
          <description>The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.</description>
          <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 week - Fix-IT Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month - Fix-IT Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month - Fix-IT Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month - Fix-IT Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)</title>
        <description>The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.&#xD;
The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').</description>
        <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
        <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)</title>
          <description>The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.&#xD;
The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').</description>
          <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 week - EQ-5D Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".605" spread=".257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month - EQ-5D Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".674" spread=".136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month - EQ-5D Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".719" spread=".131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month - EQ-5D Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".542" spread=".420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 week - Health Status</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.7" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month - Health Status</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.4" spread="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month - Health Status</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" spread="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month - Health Status</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)</title>
        <description>This will be measured using Harris Hip Score. This is quantified on a scale of 0-100 and the domains covered are pain, function, absence of deformity, and range of motion. The score is quantified on a scale of 0-100, with 100 points being the best possible outcome. The domains cover pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).</description>
        <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
        <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)</title>
          <description>This will be measured using Harris Hip Score. This is quantified on a scale of 0-100 and the domains covered are pain, function, absence of deformity, and range of motion. The score is quantified on a scale of 0-100, with 100 points being the best possible outcome. The domains cover pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).</description>
          <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 weeks - Harris Hip Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.7" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months - Harris Hip Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.3" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months - Harris Hip Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months - Harris Hip Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.7" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)</title>
        <description>This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.</description>
        <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
        <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)</title>
          <description>This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.</description>
          <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Week - Did Patient perform test?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month - Did Patient perform test?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month - Did Patient perform test?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year - Did Patient perform test?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)</title>
        <description>This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.</description>
        <time_frame>6 weeks, 3 months, 6 months, and 12 months</time_frame>
        <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects (only 5 could complete the test); at 3 months, data was available for 9 subjects (only 6 could complete the test); at 6 months, data was available for 5 subjects (only 4 could complete the test); and, at 12 months, data was available for 3 (only 1 could complete the test) of the 12 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)</title>
          <description>This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.</description>
          <population>At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects (only 5 could complete the test); at 3 months, data was available for 9 subjects (only 6 could complete the test); at 6 months, data was available for 5 subjects (only 4 could complete the test); and, at 12 months, data was available for 3 (only 1 could complete the test) of the 12 subjects.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Week - Average Time to Complete Test (seconds)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month - Average Time to Complete Test (seconds)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3" spread="39.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month - Average Time to Complete Test (seconds)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year - Average Time to Complete Test (seconds)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost-Effective Analysis</title>
        <description>Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.</description>
        <time_frame>12 months</time_frame>
        <population>Cost effective analysis was not performed due to lack of overall study data.</population>
        <group_list>
          <group group_id="O1">
            <title>N-Force Screws</title>
            <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
          </group>
        </group_list>
        <measure>
          <title>Cost-Effective Analysis</title>
          <description>Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.</description>
          <population>Cost effective analysis was not performed due to lack of overall study data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first.</time_frame>
      <desc>ISO definition is not materially different from clinicaltrials.gov definitions.</desc>
      <group_list>
        <group group_id="E1">
          <title>N-Force Screws</title>
          <description>N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.&#xD;
N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>ISO 14155:2011</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Leg Pain and failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>ISO 14155:2011</default_vocab>
        <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="8" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bout of dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Scratched eye from contacts</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Right knee pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diagnosed with Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Swollen left knee</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Left groin pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Lower Extremity/Foot Swollen</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Left hip pain and weakness after multiple falls</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>AVN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Strike Alert</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Screw loosening</sub_title>
                <counts group_id="E1" subjects_affected="1" 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>Ryan Boylan, Clinical Affairs Manager</name_or_title>
      <organization>Zimmer Biomet</organization>
      <phone>574-371-9784</phone>
      <email>ryan.boylan@zimmerbiomet.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/NCT03807349
org study id: CMU2017-60T
nct id: NCT03807349
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this prospective study is to confirm safety and performance of N-Force
      Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture
      treatment.
Primary Endpoint:

      • Re-operation within 12 months after initial surgery to promote fracture healing, relieve
      pain, treat infection, or improve function.

      Secondary Endpoints:

        -  Radiographic and clinical fracture healing of the proximal femur using standard scoring
           methods and patient satisfaction.

        -  Cost effectiveness
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With a Reoperation
time frame: 12 months
description: Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
measure: Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)
time frame: 6 weeks, 3 months, 6 months, and 12 months
description: Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).
measure: Participant Steinberg Classification at 12 Months
time frame: 12 months
description: Steinberg Classification is based on the radiographic appearance and location of lesion. It is concise and delineates the progression and extent of Avascular Necrosis (AVN) involvement more accurately.
[stage 0:] normal or non-diagnostic radiographs, MRI and bone scan of at risk hip (often contralateral hip involved, or patient has risk factors and hip pain) [stage I:] normal radiograph, abnormal bone scan and/or MRI [stage II:] cystic and sclerotic radiographic changes [stage III:] subchondral lucency or crescent sign [stage IV:] flattening of femoral head, with depression graded into mild: <2 mm moderate: 2-4 mm severe: >4 mm [stage V:] joint space narrowing with or without acetabular involvement [stage VI]: advanced degenerative changes
measure: Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)
time frame: 6 weeks, 3 months, 6 months, and 12 months
description: The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.
measure: Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)
time frame: 6 weeks, 3 months, 6 months, and 12 months
description: The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.
The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').
measure: Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)
time frame: 6 weeks, 3 months, 6 months, and 12 months
description: This will be measured using Harris Hip Score. This is quantified on a scale of 0-100 and the domains covered are pain, function, absence of deformity, and range of motion. The score is quantified on a scale of 0-100, with 100 points being the best possible outcome. The domains cover pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
measure: Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
time frame: 6 weeks, 3 months, 6 months, and 12 months
description: This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
measure: Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
time frame: 6 weeks, 3 months, 6 months, and 12 months
description: This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
measure: Cost-Effective Analysis
time frame: 12 months
description: Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.
arm group label: N-Force Screws
arm group type: Other
description: N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.
intervention type: Device
intervention name: N-Force Screws Augmented with N-Force Blue
description: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)
arm group label: N-Force Screws
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ryan Boylan, MBA
role: Study Director
affiliation: Zimmer Biomet
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 