xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05972616</url>
    </required_header>
    <id_info>
      <org_study_id>SIL-2023-NMP</org_study_id>
      <nct_id>NCT05972616</nct_id>
    </id_info>
    <brief_title>Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion</brief_title>
    <official_title>A Single-center Review of the Performance of Induce Biologics NMP™ in Patients Who Have Undergone Interbody Fusion for Degenerative Disease of the Lumbar Spine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Induce Biologics USA Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Induce Biologics USA Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used&#xD;
        to promote interbody fusion for degenerative disease of the lumbar spine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study involves a retrospective review of patients' medical records and prospective&#xD;
        collection of CT scans, X-rays, and patient centered outcome questionnaires.&#xD;
  &#xD;
        The study population will include up to 135 patients of the Spine Institute of Louisiana&#xD;
        (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All&#xD;
        subjects who meet all inclusion criteria and do not meet any exclusion criteria will be&#xD;
        included in the study.&#xD;
  &#xD;
        There will be a single Prospective Visit in this study. This visit will be scheduled at the&#xD;
        12-month (± 2 mo) post-surgery time point.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Radiographic fusion rate</measure>
      <time_frame>12-months post-surgery</time_frame>
      <description>CT scans will be graded from 0 (no boney ingrowth) to 3 (complete bridging) and A (no evidence of supplemental fixation failure) or B (evidence of supplemental fixation failure).&#xD;
  Fusion will be defined as a CT grade of 3A with less than 3 degrees of motion at the index level on flexion and extension x-rays.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in disability score assessed by Oswestry Disability Index</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Disability will be assessed using the Oswestry Disability Index (ODI). ODI is a questionnaire to collect a patient's responses to questions about perceived function (disability) in 10 everyday activities in patients with acute or chronic low back pain. Each question consists of 6 statements about 1 activity which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest. The scores are combined to a single score from 0 (no disability) to 50 (completely disabled)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in disability score assessed by the 12-Item Short Form Survey version 2</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Disability will be assessed by the 12-Item Short Form Survey version 2 (SF-12v2).&#xD;
  The SF-12 is is a questionnaire to collect a patient's responses to 12 questions about their physical and mental health. It is often used as a quality of life measure. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The minimum score for MCS-12 is 3.2 and the maximum score is 77.9. The minimum score for PCS-12 is 9.9 and the maximum score 76.0. The lower the score the worse the health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pain score - for the Back</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Pain will be assessed by Visual Analogue Scale (VAS) for back pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pain score - for the Left Leg</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Pain will be assessed by Visual Analogue Scale (VAS) for left leg pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pain score - for the Right Leg</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Pain will be assessed by Visual Analogue Scale (VAS) for right leg pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events (AE) related to NMP</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>All Adverse Events (AE) will be documented in detail and followed to a satisfactory resolution regardless of the cause. The intensity of the adverse event is determined by the investigator using the following definitions:&#xD;
  Mild: The AE is commonly asymptomatic or causes minimal symptoms and does not require any active intervention.&#xD;
  Moderate: The AE causes discomfort and requires treatment but does not pose any significant or permanent risk to harm the subject. It may or may not require any intervention.&#xD;
  Severe: Incapacitating with inability to perform usual activities. It is a definite hazard to health, reduced life expectancy, death, or life threatening, necessitates medical or surgical intervention to preclude permanent disability.&#xD;
  The number of mild, moderate and severe AE determined to be related to NMP™ will be collected and reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in neurologic status</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Neurologic status will be assessed using a grading scale during a physical exam. The patient will be scored by a clinician as to motor strength (0 to 5 paralysis to normal), sensory function based on response to touch and pin prick (0 absent, 1 numbness, 2 normal, 3 hypersensitive) and reflexes (0 absent, 1 diminished, 2 normal, 3 hyperactive, 4 hyperactive with clonus).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Revisions/reoperations</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>number of revisions or reoperations performed will be collected and reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of hospitalization</measure>
      <time_frame>time of surgery to time of discharge, assessed up to 12 months</time_frame>
      <description>number of days in hospital post-operation will be collected and reported.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">135</enrollment>
    <condition>Degenerative Disc Disease</condition>
    <arm_group>
      <arm_group_label>NMP</arm_group_label>
      <description>Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.&#xD;
  Have been treated with NMP™ during a lumbar spinal fusion procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Natural Matrix Protein (NMP)</intervention_name>
      <description>human bone allograft</description>
      <arm_group_label>NMP</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include up to 135 patients of the Spine Institute of Louisiana&#xD;
          (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion.&#xD;
          All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be&#xD;
          included in the study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Have clinical or radiological evidence of degenerative disc disease of the lumbar&#xD;
               spine.&#xD;
  &#xD;
            2. Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure.&#xD;
  &#xD;
            3. Be at least 18 years of age.&#xD;
  &#xD;
            4. Have current contact information.&#xD;
  &#xD;
            5. Be willing and able to provide written Informed Consent for the prospective part of&#xD;
               study participation.&#xD;
  &#xD;
            6. Be willing and able to undergo a CT-scan and X-rays.&#xD;
  &#xD;
            7. Be willing and able to complete patient centered outcome questionnaires.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Currently imprisoned.&#xD;
  &#xD;
            2. Currently experiencing major mental illness (psychosis, schizophrenia, major affective&#xD;
               disorder) which in the opinion of the investigator may indicate that the symptoms are&#xD;
               psychological rather than of physical origin.&#xD;
  &#xD;
            3. X-rays or CT-scan are contraindicated.&#xD;
  &#xD;
            4. Any previous lumbar fusion or arthroplasty surgery at the index level(s)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pierce Nunley, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Spine Institute of Louisiana</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Spine Institute of Louisiana</name>
        <address>
          <city>Shreveport</city>
          <state>Louisiana</state>
          <zip>71101</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>lumbar spine fusion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05972616
  org study id: SIL-2023-NMP
  nct id: NCT05972616
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used
        to promote interbody fusion for degenerative disease of the lumbar spine.
  The study involves a retrospective review of patients' medical records and prospective
        collection of CT scans, X-rays, and patient centered outcome questionnaires.
  
        The study population will include up to 135 patients of the Spine Institute of Louisiana
        (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All
        subjects who meet all inclusion criteria and do not meet any exclusion criteria will be
        included in the study.
  
        There will be a single Prospective Visit in this study. This visit will be scheduled at the
        12-month (± 2 mo) post-surgery time point.
  observational model: Cohort
  time perspective: Retrospective
  measure: Radiographic fusion rate
  time frame: 12-months post-surgery
  description: CT scans will be graded from 0 (no boney ingrowth) to 3 (complete bridging) and A (no evidence of supplemental fixation failure) or B (evidence of supplemental fixation failure).
  Fusion will be defined as a CT grade of 3A with less than 3 degrees of motion at the index level on flexion and extension x-rays.
  measure: Change in disability score assessed by Oswestry Disability Index
  time frame: Baseline to 12 months post-operative
  description: Disability will be assessed using the Oswestry Disability Index (ODI). ODI is a questionnaire to collect a patient's responses to questions about perceived function (disability) in 10 everyday activities in patients with acute or chronic low back pain. Each question consists of 6 statements about 1 activity which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest. The scores are combined to a single score from 0 (no disability) to 50 (completely disabled)
  measure: Change in disability score assessed by the 12-Item Short Form Survey version 2
  time frame: Baseline to 12 months post-operative
  description: Disability will be assessed by the 12-Item Short Form Survey version 2 (SF-12v2).
  The SF-12 is is a questionnaire to collect a patient's responses to 12 questions about their physical and mental health. It is often used as a quality of life measure. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The minimum score for MCS-12 is 3.2 and the maximum score is 77.9. The minimum score for PCS-12 is 9.9 and the maximum score 76.0. The lower the score the worse the health.
  measure: Change in pain score - for the Back
  time frame: Baseline to 12 months post-operative
  description: Pain will be assessed by Visual Analogue Scale (VAS) for back pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.
  measure: Change in pain score - for the Left Leg
  time frame: Baseline to 12 months post-operative
  description: Pain will be assessed by Visual Analogue Scale (VAS) for left leg pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.
  measure: Change in pain score - for the Right Leg
  time frame: Baseline to 12 months post-operative
  description: Pain will be assessed by Visual Analogue Scale (VAS) for right leg pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.
  measure: Adverse Events (AE) related to NMP
  time frame: Baseline to 12 months post-operative
  description: All Adverse Events (AE) will be documented in detail and followed to a satisfactory resolution regardless of the cause. The intensity of the adverse event is determined by the investigator using the following definitions:
  Mild: The AE is commonly asymptomatic or causes minimal symptoms and does not require any active intervention.
  Moderate: The AE causes discomfort and requires treatment but does not pose any significant or permanent risk to harm the subject. It may or may not require any intervention.
  Severe: Incapacitating with inability to perform usual activities. It is a definite hazard to health, reduced life expectancy, death, or life threatening, necessitates medical or surgical intervention to preclude permanent disability.
  The number of mild, moderate and severe AE determined to be related to NMP™ will be collected and reported.
  measure: Change in neurologic status
  time frame: Baseline to 12 months post-operative
  description: Neurologic status will be assessed using a grading scale during a physical exam. The patient will be scored by a clinician as to motor strength (0 to 5 paralysis to normal), sensory function based on response to touch and pin prick (0 absent, 1 numbness, 2 normal, 3 hypersensitive) and reflexes (0 absent, 1 diminished, 2 normal, 3 hyperactive, 4 hyperactive with clonus).
  measure: Revisions/reoperations
  time frame: Baseline to 12 months post-operative
  description: number of revisions or reoperations performed will be collected and reported.
  measure: Duration of hospitalization
  time frame: time of surgery to time of discharge, assessed up to 12 months
  description: number of days in hospital post-operation will be collected and reported.
  arm group label: NMP
  description: Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
  Have been treated with NMP™ during a lumbar spinal fusion procedure.
  intervention type: Biological
  intervention name: Natural Matrix Protein (NMP)
  description: human bone allograft
  arm group label: NMP
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Pierce Nunley, MD
  role: Principal Investigator
  affiliation: Spine Institute of Louisiana
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Intervertebral Disc Degeneration
  sharing ipd: No