<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/NCT02183727</url>
  </required_header>
  <id_info>
    <org_study_id>LC1060</org_study_id>
    <nct_id>NCT02183727</nct_id>
  </id_info>
  <brief_title>L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction</brief_title>
  <official_title>L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soft Tissue Regeneration, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soft Tissue Regeneration, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament&#xD;
      versus Hamstring Autograft for treatment of acute rupture of the ACL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Data from LC1033 study of same product indicated lower than expected clinical outcomes;&#xD;
    company, STR did not have funds to continue study.&#xD;
  </why_stopped>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">July 2020</completion_date>
  <primary_completion_date type="Actual">June 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Graft Failure</measure>
    <time_frame>12 Months</time_frame>
    <description>Revision surgery rate at one year</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Knee Function measured by the IKDC</measure>
    <time_frame>12 Months</time_frame>
    <description>Physical Knee Function at 12 Months post procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>Day 1</time_frame>
    <description>Pain levels day 1 post-procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event rates</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of AEs throughout the first year of follow-up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical Knee Function as measured by the Lysholm scale</measure>
    <time_frame>over 24 months</time_frame>
    <description>Physical Knee Function scores at all follow-up timepoints through Month 24</description>
  </other_outcome>
  <other_outcome>
    <measure>Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale</measure>
    <time_frame>over 24 months</time_frame>
    <description>Physical activity level scores at all follow-up timepoints through Month 24</description>
  </other_outcome>
  <other_outcome>
    <measure>Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS</measure>
    <time_frame>over 24 months</time_frame>
    <description>KOOS scores at all follow-up timepoints through Month 24</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acute Ruptures of the Anterior Cruciate Ligament</condition>
  <arm_group>
    <arm_group_label>L-C Ligament</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft Tissue Regeneration's L-C Ligament is an investigation, interventional device intended for ACL reconstruction surgery within 18 weeks of acute rupture of the ACL and no previous surgical treatment. The L-C Ligament temporarily replaces the human anterior cruciate ligament (ACL) and provides a bioresorbable scaffold within and around which the native ACL will regenerate over time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hamstring Autograft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>L-C Ligament</intervention_name>
    <description>The L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL.</description>
    <arm_group_label>L-C Ligament</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hamstring Autograft</intervention_name>
    <description>The gold-standard treatment for ACL reconstruction is autograft tissue. Autograft is a piece of tendon harvested from another part of the patient's body, such as the hamstring or kneecap. In this study, the hamstring tendon from the back of the thigh of the injured (target) leg will be harvested and surgically transferred to replace the torn ACL. The attachment of the autologous tendon in the femoral and tibial bone tunnels will utilize techniques that are similar to those for the L-C Ligament. Over time the replacement tendon resorbs and a new ACL is regenerated.</description>
    <arm_group_label>Hamstring Autograft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute ruptures of the ACL who are willing to undergo treatment within 18&#xD;
             weeks of injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior ACL reconstruction or other surgical procedure on the affected (target) knee&#xD;
&#xD;
          -  Chronic ACL injury; interventional surgery scheduled 127 days or more after ACL injury&#xD;
&#xD;
          -  Professional athletes currently engaged in active sport&#xD;
&#xD;
          -  Prior distal femoral and/or proximal tibial fracture(s) of the target leg&#xD;
&#xD;
          -  Previous or current ACL injury on contra-lateral leg&#xD;
&#xD;
          -  Multi-ligament reconstruction&#xD;
&#xD;
          -  Malalignment or varus thrust&#xD;
&#xD;
          -  Patient &gt; 193 cm tall (6' 4&quot;)&#xD;
&#xD;
          -  The patient does not follow pre-operative rehabilitation that may have been prescribed&#xD;
             post-injury (prior to Index Procedure)&#xD;
&#xD;
          -  Confirmed connective tissue disorder&#xD;
&#xD;
          -  Signs of moderate to severe degenerative joint disease&#xD;
&#xD;
          -  Severe pain, swelling, or redness within 24 hours prior to surgery&#xD;
&#xD;
          -  Complete or partial Posterior Cruciate Ligament (PCL) tear&#xD;
&#xD;
          -  If concomitant meniscal injury is present, any of the following: 1/3rd meniscal&#xD;
             resection; complex double-bucket tear; partially repaired meniscal tears&#xD;
&#xD;
          -  Any type of lateral and/or medial meniscal tear which is not repairable (&lt;2mm from&#xD;
             rim)&#xD;
&#xD;
          -  Additional concomitant injuries to the knee or lower extremities requiring treatment,&#xD;
             per surgeon's discretion, that are not allowable under the Inclusion criteria&#xD;
&#xD;
          -  The patient is unwilling to not participate in sporting activities for at least 9&#xD;
             months post-procedure&#xD;
&#xD;
          -  The patient is mentally compromised&#xD;
&#xD;
          -  The patient has a neuromuscular disorder that would engender unacceptable risk of knee&#xD;
             instability, prosthesis fixation failure, or complications in postoperative care&#xD;
&#xD;
          -  The patient has an active or latent infection in or about the affected knee joint or&#xD;
             an infection site distant from the knee that may spread to the knee hematogenously&#xD;
&#xD;
          -  Pregnant based on a positive beta hCG serum or an in vitro diagnostic test result or&#xD;
             breast-feeding&#xD;
&#xD;
          -  The patient is obese with a BMI &gt; 35&#xD;
&#xD;
          -  The patient has a known allergy to PLLA&#xD;
&#xD;
          -  The patient has a medical condition or comorbidity that would interfere with study&#xD;
             participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kees van Egmond, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isala Klinieken, Zwolle, The Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Isala Klinieken</name>
      <address>
        <city>Zwolle</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>November 12, 2021</last_update_submitted>
  <last_update_submitted_qc>November 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ACL</keyword>
  <keyword>knee injury</keyword>
  <keyword>anterior cruciate ligament</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <!-- 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/NCT02183727
org study id: LC1060
nct id: NCT02183727
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament
      versus Hamstring Autograft for treatment of acute rupture of the ACL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Graft Failure
time frame: 12 Months
description: Revision surgery rate at one year
measure: Physical Knee Function measured by the IKDC
time frame: 12 Months
description: Physical Knee Function at 12 Months post procedure
measure: Pain Score
time frame: Day 1
description: Pain levels day 1 post-procedure
measure: Adverse event rates
time frame: 12 months
description: Rate of AEs throughout the first year of follow-up
measure: Physical Knee Function as measured by the Lysholm scale
time frame: over 24 months
description: Physical Knee Function scores at all follow-up timepoints through Month 24
measure: Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale
time frame: over 24 months
description: Physical activity level scores at all follow-up timepoints through Month 24
measure: Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS
time frame: over 24 months
description: KOOS scores at all follow-up timepoints through Month 24
arm group label: L-C Ligament
arm group type: Experimental
description: Soft Tissue Regeneration's L-C Ligament is an investigation, interventional device intended for ACL reconstruction surgery within 18 weeks of acute rupture of the ACL and no previous surgical treatment. The L-C Ligament temporarily replaces the human anterior cruciate ligament (ACL) and provides a bioresorbable scaffold within and around which the native ACL will regenerate over time.
arm group label: Hamstring Autograft
arm group type: Active Comparator
description: Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction.
intervention type: Device
intervention name: L-C Ligament
description: The L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL.
arm group label: L-C Ligament
intervention type: Procedure
intervention name: Hamstring Autograft
description: The gold-standard treatment for ACL reconstruction is autograft tissue. Autograft is a piece of tendon harvested from another part of the patient's body, such as the hamstring or kneecap. In this study, the hamstring tendon from the back of the thigh of the injured (target) leg will be harvested and surgically transferred to replace the torn ACL. The attachment of the autologous tendon in the femoral and tibial bone tunnels will utilize techniques that are similar to those for the L-C Ligament. Over time the replacement tendon resorbs and a new ACL is regenerated.
arm group label: Hamstring Autograft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Kees van Egmond, MD
role: Principal Investigator
affiliation: Isala Klinieken, Zwolle, The Netherlands
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Rupture