<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/NCT02203214</url>
  </required_header>
  <id_info>
    <org_study_id>V03_29082013</org_study_id>
    <nct_id>NCT02203214</nct_id>
  </id_info>
  <brief_title>Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series</brief_title>
  <acronym>Ligamys</acronym>
  <official_title>Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mathys Ltd Bettlach</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mathys Ltd Bettlach</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and effectiveness of the Ligamys&#xD;
      technique for the treatment of acute ruptures of the anterior cruciate ligament in a&#xD;
      multicenter routine clinical setting. To conduct a long-term follow-up of the case series as&#xD;
      a post-market product surveillance endeavor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Ligamys method was successfully applied in an animal study including eleven white alpine&#xD;
      sheep. Healing of the torn ACL and a stable joint without signs of intra-articular damages or&#xD;
      osteoarthritis three months postoperative were observed (Kohl KSSTA 2013). In a first&#xD;
      clinical study with ten patients, the Ligamys surgical technique resulted in stable clinical&#xD;
      and radiological healing of the torn ACL in nine patients with one re-rupture after four&#xD;
      months. Nine patients obtained normal knee scores, reported excellent patient satisfaction,&#xD;
      and could return to their previous levels of sporting activity (Kohl Swiss Med Wkly 2011).&#xD;
&#xD;
      The purpose of this study is to evaluate the safety and effectiveness of the Ligamys&#xD;
      technique for the treatment of acute ruptures of the anterior cruciate ligament in a&#xD;
      multicenter routine clinical setting. To conduct a long-term follow-up of the case series as&#xD;
      a post-market product surveillance endeavor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Knee stability and function plus safety aspects</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Knee stability: Lachman test Knee function: Lysholm score, IKDC score Safety: ACL re-ruptures or instabilities leading to an implant removal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint</measure>
    <time_frame>10 years follow-up</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Anterior Cruciate Ligament Rupture</condition>
  <arm_group>
    <arm_group_label>Ligamys</arm_group_label>
    <description>All patients treated with Ligamys can be included in the study. Patients must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ligamys</intervention_name>
    <description>All patients are treated with Ligamys within 21 days after injury. The Ligamys implant has to be used in accordance with the instructions for use.</description>
    <arm_group_label>Ligamys</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an acute rupture of the anterior cruciate ligament&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary rupture of the anterior cruciate ligament&#xD;
&#xD;
          -  Signed patient informed consent&#xD;
&#xD;
          -  Willingness to present for follow-up&#xD;
&#xD;
          -  Age between 18 and 50 years at the time of inclusion in the study&#xD;
&#xD;
          -  Injury - surgery time interval of 21 days or less&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical non-compliance&#xD;
&#xD;
          -  Unwillingness to follow the rehabilitation programme&#xD;
&#xD;
          -  Traumatic cartilage lesion requiring cartilage repair procedure (Microfracturing,&#xD;
             MACI, ACT) or degenerative cartilage lesions (Outerbridge &gt;ll and defect &gt;1cm2)&#xD;
&#xD;
          -  Non-repairable meniscus lesions requiring a resection of &gt;20%&#xD;
&#xD;
          -  Previous tendon removal on injured leg&#xD;
&#xD;
          -  Relevant permanent medication (Steroids, cytostatic drugs, ...)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Eggli, Prof Dr med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik Sonnenhof, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sonnenhof</name>
      <address>
        <city>Bern</city>
        <zip>3008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.ligamys.com</url>
    <description>Click here for more information about this treatment option</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>August 16, 2018</last_update_submitted>
  <last_update_submitted_qc>August 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ligamys</keyword>
  <keyword>ACL</keyword>
  <keyword>healing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02203214
org study id: V03_29082013
nct id: NCT02203214
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and effectiveness of the Ligamys
      technique for the treatment of acute ruptures of the anterior cruciate ligament in a
      multicenter routine clinical setting. To conduct a long-term follow-up of the case series as
      a post-market product surveillance endeavor.
The Ligamys method was successfully applied in an animal study including eleven white alpine
      sheep. Healing of the torn ACL and a stable joint without signs of intra-articular damages or
      osteoarthritis three months postoperative were observed (Kohl KSSTA 2013). In a first
      clinical study with ten patients, the Ligamys surgical technique resulted in stable clinical
      and radiological healing of the torn ACL in nine patients with one re-rupture after four
      months. Nine patients obtained normal knee scores, reported excellent patient satisfaction,
      and could return to their previous levels of sporting activity (Kohl Swiss Med Wkly 2011).

      The purpose of this study is to evaluate the safety and effectiveness of the Ligamys
      technique for the treatment of acute ruptures of the anterior cruciate ligament in a
      multicenter routine clinical setting. To conduct a long-term follow-up of the case series as
      a post-market product surveillance endeavor.
observational model: Case-Only
time perspective: Prospective
measure: Knee stability and function plus safety aspects
time frame: 12 months follow-up
description: Knee stability: Lachman test Knee function: Lysholm score, IKDC score Safety: ACL re-ruptures or instabilities leading to an implant removal
measure: Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint
time frame: 10 years follow-up
arm group label: Ligamys
description: All patients treated with Ligamys can be included in the study. Patients must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled.
intervention type: Device
intervention name: Ligamys
description: All patients are treated with Ligamys within 21 days after injury. The Ligamys implant has to be used in accordance with the instructions for use.
arm group label: Ligamys
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Stefan Eggli, Prof Dr med
role: Principal Investigator
affiliation: Klinik Sonnenhof, Switzerland
facility: 
facility: 
facility: 
country: Belgium
country: Germany
country: Switzerland
url: http://www.ligamys.com
description: Click here for more information about this treatment option
responsible party type: Sponsor
mesh term: Rupture
sharing ipd: Undecided