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/NCT06000319</url>
    </required_header>
    <id_info>
      <org_study_id>CT-NMP-001</org_study_id>
      <nct_id>NCT06000319</nct_id>
    </id_info>
    <brief_title>Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion</brief_title>
    <official_title>Prospective Evaluation of Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion</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 aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™&#xD;
        (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative&#xD;
        disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar&#xD;
        interbody spine fusion at no more than 3 adjacent levels.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study involves a retrospective review of patients' medical records and prospective&#xD;
        collection of X-rays, and patient outcome questionnaires.&#xD;
  &#xD;
        The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive&#xD;
        cervical interbody fusion patients who meet the inclusion criteria and do not meet the&#xD;
        exclusion criteria.&#xD;
  &#xD;
        There will be 4 prospective study visits following consent. Follow-up will occur in&#xD;
        accordance with standard of care practice and will continue to 12 months post-surgery&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of interbody fusion</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of secondary surgical intervention</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Adverse Product Related Events</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of bridging bone</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Plane radiographs will be evaluated for the presence of bridging bone at each level to be fused.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in disability score for lumbar fusion patients 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 for cervical fusion patients assessed by Neck Disability Index</measure>
      <time_frame>Baseline to 12 months post-operative</time_frame>
      <description>Disability will be assessed using the Neck Disability Index (NDI). NDI 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 neck 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 back pain in lumbar fusion patients</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 millimeters from the 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 leg pain in lumbar fusion patients</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 millimeters from the 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 neck pain in cervical fusion patients</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 millimeters from the 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 arm pain in cervical fusion patients</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 millimeters from the 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>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Degenerative Disc Disease</condition>
    <condition>Degenerative Spondylolisthesis</condition>
    <condition>Spinal Stenosis</condition>
    <arm_group>
      <arm_group_label>Lumbar Interbody Fusion with NMP</arm_group_label>
      <description>Subject has undergone lumbar interbody spine fusion at no more than 3 adjacent levels between L1 and S1 where NMP fibers have been used as a bone void filler</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cervical Interbody Fusion with NMP</arm_group_label>
      <description>Subject has undergone cervical interbody spine fusion at no more than 3 adjacent levels between C2 and T1 where NMP fibers have been used as a bone void filler</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Natural Matrix Protein (NMP) Fibers</intervention_name>
      <description>human bone allograft</description>
      <arm_group_label>Cervical Interbody Fusion with NMP</arm_group_label>
      <arm_group_label>Lumbar Interbody Fusion with NMP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Lumbar interbody fusion</intervention_name>
      <description>Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.</description>
      <arm_group_label>Lumbar Interbody Fusion with NMP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Cervical interbody fusion</intervention_name>
      <description>Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.</description>
      <arm_group_label>Cervical Interbody Fusion with NMP</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include up to 200 patients who have been treated with Induce&#xD;
          Biologics NMP™ during cervical or lumbar interbody fusion. All subjects who meet all&#xD;
          inclusion criteria and do not meet any exclusion criteria will be included in the study. It&#xD;
          is expected that enrollment will take 12 months to complete.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;&#xD;
  &#xD;
            2. Subject has undergone cervical or lumbar interbody spine fusion at no more than 3&#xD;
               adjacent levels between C2 and T1 or between L1 and S1;&#xD;
  &#xD;
            3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;&#xD;
  &#xD;
            4. Subject must be 18 years of age or older at the time of consent;&#xD;
  &#xD;
            5. Subject must be willing and able to sign an informed consent document;&#xD;
  &#xD;
            6. Subject must be willing and able to return to the study clinic for all follow-up&#xD;
               visits, agree to participate in post-operative clinical and radiographic evaluations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject is under 18 years of age at the time of consent;&#xD;
  &#xD;
            2. Subject is currently experiencing major mental illness (psychosis, schizophrenia,&#xD;
               major affective disorder) which in the opinion of the investigator may indicate that&#xD;
               the symptoms are psychological rather than of physical origin;&#xD;
  &#xD;
            3. Subject is currently imprisoned.&#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>Mark A Prevost Sr, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Southern Orthopedic Sports Medicine Associates</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mark A Prevost II, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Southern Orthopedic Sports Medicine Associates</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sean A Peel, Ph.D.</last_name>
      <phone>416-898-9724</phone>
      <email>sean.peel@redrockregen.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Southern Orthopedic Sports Medicine Associates</name>
        <address>
          <city>Jasper</city>
          <state>Alabama</state>
          <zip>35501</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Stenosis</mesh_term>
      <mesh_term>Intervertebral Disc Degeneration</mesh_term>
      <mesh_term>Spondylolisthesis</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/NCT06000319
  org study id: CT-NMP-001
  nct id: NCT06000319
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™
        (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative
        disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar
        interbody spine fusion at no more than 3 adjacent levels.
  The study involves a retrospective review of patients' medical records and prospective
        collection of X-rays, and patient outcome questionnaires.
  
        The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive
        cervical interbody fusion patients who meet the inclusion criteria and do not meet the
        exclusion criteria.
  
        There will be 4 prospective study visits following consent. Follow-up will occur in
        accordance with standard of care practice and will continue to 12 months post-surgery
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of interbody fusion
  time frame: Baseline to 12 months post-operative
  description: Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level.
  measure: Incidence of secondary surgical intervention
  time frame: Baseline to 12 months post-operative
  description: Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels
  measure: Incidence of Adverse Product Related Events
  time frame: Baseline to 12 months post-operative
  description: the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis.
  measure: Incidence of bridging bone
  time frame: Baseline to 12 months post-operative
  description: Plane radiographs will be evaluated for the presence of bridging bone at each level to be fused.
  measure: Change in disability score for lumbar fusion patients 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 for cervical fusion patients assessed by Neck Disability Index
  time frame: Baseline to 12 months post-operative
  description: Disability will be assessed using the Neck Disability Index (NDI). NDI 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 neck 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 back pain in lumbar fusion patients
  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 millimeters from the 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 leg pain in lumbar fusion patients
  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 millimeters from the 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 neck pain in cervical fusion patients
  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 millimeters from the 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 arm pain in cervical fusion patients
  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 millimeters from the 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.
  arm group label: Lumbar Interbody Fusion with NMP
  description: Subject has undergone lumbar interbody spine fusion at no more than 3 adjacent levels between L1 and S1 where NMP fibers have been used as a bone void filler
  arm group label: Cervical Interbody Fusion with NMP
  description: Subject has undergone cervical interbody spine fusion at no more than 3 adjacent levels between C2 and T1 where NMP fibers have been used as a bone void filler
  intervention type: Biological
  intervention name: Natural Matrix Protein (NMP) Fibers
  description: human bone allograft
  arm group label: Cervical Interbody Fusion with NMP
  arm group label: Lumbar Interbody Fusion with NMP
  intervention type: Procedure
  intervention name: Lumbar interbody fusion
  description: Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
  arm group label: Lumbar Interbody Fusion with NMP
  intervention type: Procedure
  intervention name: Cervical interbody fusion
  description: Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
  arm group label: Cervical Interbody Fusion with NMP
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mark A Prevost Sr, MD
  role: Principal Investigator
  affiliation: Southern Orthopedic Sports Medicine Associates
  last name: Mark A Prevost II, MD
  role: Principal Investigator
  affiliation: Southern Orthopedic Sports Medicine Associates
  last name: Sean A Peel, Ph.D.
  phone: 416-898-9724
  email: sean.peel@redrockregen.com
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Spinal Stenosis
  mesh term: Intervertebral Disc Degeneration
  mesh term: Spondylolisthesis
  sharing ipd: No