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/NCT06041763</url>
    </required_header>
    <id_info>
      <org_study_id>23-00813</org_study_id>
      <nct_id>NCT06041763</nct_id>
    </id_info>
    <brief_title>Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair</brief_title>
    <official_title>Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NYU Langone Health</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 bridge-enhanced ACL repair (BEAR) implant is a collagen-based scaffold loaded with whole&#xD;
        blood. It is designed to promote healing in the setting of intraarticular knee pathology.&#xD;
        This study would compare clinical outcomes and synovial fluid cytokine profiles in patients&#xD;
        who undergo isolated meniscal repair with or without the BEAR implant.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score</measure>
      <time_frame>Baseline, 1 Year Post-Procedure</time_frame>
      <description>10-item assessment of knee-related symptoms at the present moment and over the previous 4 weeks. Each item is rated according to presence of symptoms. The raw score is the sum of responses and is rescaled to a total score ranging from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Lysholm Scale Score</measure>
      <time_frame>Baseline, 1 Year Post-Procedure</time_frame>
      <description>8-item assessment of knee-related activity and problems at the present moment. Each item is rated on a Likert-type scale. The total score is the sum of responses and ranges from 0 to 100, with higher scores indicating greater level of function/lower level of symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Visual Analogue Scale (VAS) Score</measure>
      <time_frame>Baseline, 1 Year Post-Procedure</time_frame>
      <description>One-item assessment of pain on the current day. Pain is rated on a scale from 0 (no pain) to 10 (worst possible, unbearable, excruciating pain); the total score is the numerical rating.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Repair Failure</measure>
      <time_frame>Up to 1 Year Post-Procedure</time_frame>
      <description>Instances of failure of the meniscal repair.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Meniscus Tear</condition>
    <arm_group>
      <arm_group_label>BEAR Implant</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Repair</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>adult patients with meniscus injury indicated for isolated meniscus repair. In the standard repair group, participants will undergo an isolated meniscus repair without the implant.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Meniscal Repair Procedure</intervention_name>
      <description>All meniscal repairs will be performed by the surgeons who are listed as investigators for the study. Meniscal repair consists of arthroscopic suturing of torn fragments. This takes approximately 20 minutes. In the interventional group, the BEAR implant will be inserted through preexistent arthroscopic portals after repair is complete. This will take an additional 2 minutes.</description>
      <arm_group_label>BEAR Implant</arm_group_label>
      <arm_group_label>Standard Repair</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>BEAR Implant</intervention_name>
      <description>The BEAR Implant (22 mm in diameter and 45mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam inadiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.</description>
      <arm_group_label>BEAR Implant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • History of meniscus injury indicated for isolated repair, without concomitant ligament&#xD;
          reconstruction or repair, cartilage repair procedure, or osteotomy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are undergoing meniscal repair for displaced bucket-handle meniscal tears&#xD;
  &#xD;
            -  Patients with a history of blood-borne diseases including HIV, hepatitis B virus,&#xD;
               hepatitis C virus, human T-lymphotropic virus, and syphilis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guillem Gonzalez-Lomas, MD Gonzalez-Lomas, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Isabel Wolfe</last_name>
      <phone>(207)-749-6369</phone>
      <email>isabel.wolfe@nyulangone.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Michael Moore</last_name>
      <phone>(347)-554-0183</phone>
      <email>Michael.moore@nyulangone.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NYU Langone Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: isabel.wolfe@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
      <ipd_access_criteria>The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to isabel.wolfe@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </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/NCT06041763
  org study id: 23-00813
  nct id: NCT06041763
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The bridge-enhanced ACL repair (BEAR) implant is a collagen-based scaffold loaded with whole
        blood. It is designed to promote healing in the setting of intraarticular knee pathology.
        This study would compare clinical outcomes and synovial fluid cytokine profiles in patients
        who undergo isolated meniscal repair with or without the BEAR implant.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
  time frame: Baseline, 1 Year Post-Procedure
  description: 10-item assessment of knee-related symptoms at the present moment and over the previous 4 weeks. Each item is rated according to presence of symptoms. The raw score is the sum of responses and is rescaled to a total score ranging from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
  measure: Change in Lysholm Scale Score
  time frame: Baseline, 1 Year Post-Procedure
  description: 8-item assessment of knee-related activity and problems at the present moment. Each item is rated on a Likert-type scale. The total score is the sum of responses and ranges from 0 to 100, with higher scores indicating greater level of function/lower level of symptoms.
  measure: Change in Visual Analogue Scale (VAS) Score
  time frame: Baseline, 1 Year Post-Procedure
  description: One-item assessment of pain on the current day. Pain is rated on a scale from 0 (no pain) to 10 (worst possible, unbearable, excruciating pain); the total score is the numerical rating.
  measure: Incidence of Repair Failure
  time frame: Up to 1 Year Post-Procedure
  description: Instances of failure of the meniscal repair.
  arm group label: BEAR Implant
  arm group type: Experimental
  description: Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure.
  arm group label: Standard Repair
  arm group type: Active Comparator
  description: adult patients with meniscus injury indicated for isolated meniscus repair. In the standard repair group, participants will undergo an isolated meniscus repair without the implant.
  intervention type: Procedure
  intervention name: Meniscal Repair Procedure
  description: All meniscal repairs will be performed by the surgeons who are listed as investigators for the study. Meniscal repair consists of arthroscopic suturing of torn fragments. This takes approximately 20 minutes. In the interventional group, the BEAR implant will be inserted through preexistent arthroscopic portals after repair is complete. This will take an additional 2 minutes.
  arm group label: BEAR Implant
  arm group label: Standard Repair
  intervention type: Device
  intervention name: BEAR Implant
  description: The BEAR Implant (22 mm in diameter and 45mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam inadiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.
  arm group label: BEAR Implant
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Guillem Gonzalez-Lomas, MD Gonzalez-Lomas, MD
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Isabel Wolfe
  phone: (207)-749-6369
  email: isabel.wolfe@nyulangone.org
  last name: Michael Moore
  phone: (347)-554-0183
  email: Michael.moore@nyulangone.org
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: isabel.wolfe@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
  ipd access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to isabel.wolfe@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.