<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/NCT04462458</url>
  </required_header>
  <id_info>
    <org_study_id>P07.001.01</org_study_id>
    <nct_id>NCT04462458</nct_id>
  </id_info>
  <brief_title>M-ARS ACL Post-marketing Surveillance Study</brief_title>
  <official_title>Clinical and Radiological Outcomes of M-ARS ACL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medacta International SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medacta International SA</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery&#xD;
      (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.&#xD;
&#xD;
      The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The&#xD;
      secondary goals are to assess the survival rate, clinical and functional outcomes, the&#xD;
      quality of life, and the rate of complications at 1 month, 1 year and 2 years&#xD;
      post-operatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This s a prospective, multicenter, non-controlled, observational study to evaluate the&#xD;
      outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior&#xD;
      cruciate ligament (ACL).&#xD;
&#xD;
      Participants will be informed about the study, both orally and in writing, during a&#xD;
      preoperative visit. The investigator will answer any questions that may arise and will&#xD;
      collect the informed consent. During the study, enrolled participants will be able to&#xD;
      withdraw at any time and for any reason.&#xD;
&#xD;
      The study is conducted according to the following schedule:&#xD;
&#xD;
        -  V1 : Inclusion during a preoperative visit&#xD;
&#xD;
        -  V2: Surgery&#xD;
&#xD;
        -  V3: Follow-up visit at 1 month ± 15 days post-surgery&#xD;
&#xD;
        -  V4: Follow-up visit at 6 months ± 30 days post-surgery&#xD;
&#xD;
        -  V5: Follow-up visit at 12 months ± 60 days post-surgery&#xD;
&#xD;
        -  V6: Follow-up visit at 24 months ± 90 days post-surgery&#xD;
&#xD;
      The following data will be collected:&#xD;
&#xD;
        -  Survival rate of implants evaluating the incidence of implants failure, where implant&#xD;
           failure is defined as revision, loosening, or any definite change in the position of&#xD;
           components (V3-V6).&#xD;
&#xD;
        -  Clinical and functional outcomes, measured with the International Knee Documentation&#xD;
           Committee (IKDC) score (V1, V3-V6)&#xD;
&#xD;
        -  Quality of Life, measured with the EQ-5D score (V1, V3-V6)&#xD;
&#xD;
        -  Occurrence of intraoperative and postoperative complications (V2-V6)&#xD;
&#xD;
      Depending on standard practice, imaging assessment of implants and bone tunnels may be&#xD;
      performed.&#xD;
&#xD;
      A web-based data collection tool will be used as Electronic Data Capture (EDC). All the&#xD;
      information required by the protocol will be collected in electronic case report forms&#xD;
      (eCRF).&#xD;
&#xD;
      The statistical analysis will be performed according to a pre-established statistical&#xD;
      analysis plan. Missing values will not be replaced by estimated values but will be considered&#xD;
      as missing in the statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2022</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">July 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>Survival rate</measure>
    <time_frame>6 months</time_frame>
    <description>Kaplan Meier method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival rate</measure>
    <time_frame>1, 12, 24 months</time_frame>
    <description>Kaplan Meier method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>1, 6, 12, 24 months</time_frame>
    <description>International Knee Documentation Committee (IKDC) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life outcome</measure>
    <time_frame>1, 6, 12, 24 months</time_frame>
    <description>EQ-5D score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcome (optional)</measure>
    <time_frame>1, 6, 12, 24 months</time_frame>
    <description>Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>intraoperative, 1, 6, 12, 24 months</time_frame>
    <description>Occurrence of intraoperative and postoperative complications</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Anterior Cruciate Ligament (ACL) Reconstruction</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medacta Anatomic Ribbon Surgery (M-ARS ACL)</intervention_name>
    <description>M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients requiring ACL reconstruction and who are suitable to receive M-ARS ACL will be&#xD;
        proposed to take part to the current post-marketing surveillance study during their&#xD;
        pre-operative visit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years&#xD;
&#xD;
          -  Patients with ACL rupture requiring ACL reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with malignant diseases (at the time of surgery)&#xD;
&#xD;
          -  Patients with proven or suspected infections (at the time of surgery)&#xD;
&#xD;
          -  Patients with functional deficits of the affected extremity (at the time of surgery)&#xD;
&#xD;
          -  Patients with known incompatibility or allergy to products materials (at the time of&#xD;
             surgery)&#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>Mirco Herbort, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>OCM Klinik GmbH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denise Falcone</last_name>
    <phone>+41916966060</phone>
    <email>falcone@medacta.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Praxis Gelenkpunkt - Sport- und Gelenkchirurgie</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Fink, Prof. Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pyhrn-Eisenwurzen Klinikum Kirchdorf</name>
      <address>
        <city>Kirchdorf An Der Krems</city>
        <zip>4560</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simone Danese, OA Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>OCM Klinik GmbH</name>
      <address>
        <city>München</city>
        <zip>81369</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04462458
org study id: P07.001.01
nct id: NCT04462458
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery
      (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.

      The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The
      secondary goals are to assess the survival rate, clinical and functional outcomes, the
      quality of life, and the rate of complications at 1 month, 1 year and 2 years
      post-operatively.
This s a prospective, multicenter, non-controlled, observational study to evaluate the
      outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior
      cruciate ligament (ACL).

      Participants will be informed about the study, both orally and in writing, during a
      preoperative visit. The investigator will answer any questions that may arise and will
      collect the informed consent. During the study, enrolled participants will be able to
      withdraw at any time and for any reason.

      The study is conducted according to the following schedule:

        -  V1 : Inclusion during a preoperative visit

        -  V2: Surgery

        -  V3: Follow-up visit at 1 month ± 15 days post-surgery

        -  V4: Follow-up visit at 6 months ± 30 days post-surgery

        -  V5: Follow-up visit at 12 months ± 60 days post-surgery

        -  V6: Follow-up visit at 24 months ± 90 days post-surgery

      The following data will be collected:

        -  Survival rate of implants evaluating the incidence of implants failure, where implant
           failure is defined as revision, loosening, or any definite change in the position of
           components (V3-V6).

        -  Clinical and functional outcomes, measured with the International Knee Documentation
           Committee (IKDC) score (V1, V3-V6)

        -  Quality of Life, measured with the EQ-5D score (V1, V3-V6)

        -  Occurrence of intraoperative and postoperative complications (V2-V6)

      Depending on standard practice, imaging assessment of implants and bone tunnels may be
      performed.

      A web-based data collection tool will be used as Electronic Data Capture (EDC). All the
      information required by the protocol will be collected in electronic case report forms
      (eCRF).

      The statistical analysis will be performed according to a pre-established statistical
      analysis plan. Missing values will not be replaced by estimated values but will be considered
      as missing in the statistical analysis.
observational model: Cohort
time perspective: Prospective
measure: Survival rate
time frame: 6 months
description: Kaplan Meier method
measure: Survival rate
time frame: 1, 12, 24 months
description: Kaplan Meier method
measure: Functional outcome
time frame: 1, 6, 12, 24 months
description: International Knee Documentation Committee (IKDC) score
measure: Quality of Life outcome
time frame: 1, 6, 12, 24 months
description: EQ-5D score
measure: Radiological outcome (optional)
time frame: 1, 6, 12, 24 months
description: Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel
measure: Complication rate
time frame: intraoperative, 1, 6, 12, 24 months
description: Occurrence of intraoperative and postoperative complications
intervention type: Device
intervention name: Medacta Anatomic Ribbon Surgery (M-ARS ACL)
description: M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mirco Herbort, Prof. Dr. med.
role: Principal Investigator
affiliation: OCM Klinik GmbH
last name: Denise Falcone
phone: +41916966060
email: falcone@medacta.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
country: Austria
country: Germany
responsible party type: Sponsor