<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/NCT02200302</url>
  </required_header>
  <id_info>
    <org_study_id>AF - 02</org_study_id>
    <nct_id>NCT02200302</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Adolescent Idiopathic Scoliosis (AIS)</brief_title>
  <acronym>MID-C</acronym>
  <official_title>Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Adolescent Idiopathic Scoliosis (AIS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Apifix</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Apifix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the&#xD;
      vertebrae and discs gradually develop a curvature that is first detected in patients between&#xD;
      11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from&#xD;
      radiographs by the Cobb angle .&#xD;
&#xD;
      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each&#xD;
      vertebra and disc between the superior and inferior end vertebrae . Although a small curve is&#xD;
      well tolerated and does not require treatment, a large curve can progress to the point that&#xD;
      it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac&#xD;
      and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the&#xD;
      initiation of the curve and its subsequent progression. The factors responsible for the&#xD;
      initiation of the curve are unknown, but the subsequent progression of the curve is clearly&#xD;
      associated with the adolescent growth spurt . The primary risk factors for progression&#xD;
      include age at onset and the magnitude of the curve; young patients with large curves are at&#xD;
      the highest risk .&#xD;
&#xD;
      Although numerous treatment methods have been recommended for patients with AIS, the only&#xD;
      accepted treatment includes bracing for skeletally immature patients with curves between 25&#xD;
      and 40 degrees and operative correction with spinal fusion for patients with curves greater&#xD;
      than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing&#xD;
      has caused compliance problems with wearing the brace and many patients only wear the brace&#xD;
      at home . While operative intervention completely corrects the scoliosis or rib hump, it&#xD;
      eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion&#xD;
      potentially leading to disc degeneration and back pain.&#xD;
&#xD;
      Despite satisfactory short-term results of operative instrumentation and fusion, a less&#xD;
      invasive technique preserving more motion with a smaller scar represents a major improvement.&#xD;
      Realizing this goal is contingent on treating curves early, before they progress to an&#xD;
      irreversible deformity, and when there is still enough residual growth and remodeling&#xD;
      potential.&#xD;
&#xD;
      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system&#xD;
      is designed to correct the deformity step by step along a period of time, giving the skeletal&#xD;
      and soft tissues time to accommodate any incremental correction.&#xD;
&#xD;
      The MID-C System inherent benefits are:&#xD;
&#xD;
        -  Only two screws are used&#xD;
&#xD;
        -  Incision size is much smaller&#xD;
&#xD;
        -  Simpler operation with shorter operative time&#xD;
&#xD;
        -  Less complications (attributed to the three points above).&#xD;
&#xD;
        -  Minimal spinal mobility loss.&#xD;
&#xD;
      All the device components are made of materials well accepted in the orthopedic field and are&#xD;
      fully biocompatible (see Investigator Brochure).&#xD;
&#xD;
      The unique concept of the system and the materials used may provide favorable results as&#xD;
      follows: Smaller scare, quicker healing period and better spine mobility over the years.&#xD;
&#xD;
      This study is designed to demonstrate that the MID-C System is safe and effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed as a European, observational study with a 12-month follow-up period.&#xD;
      Consecutive patients undergoing treatment of AIS by the MID-C system in daily practice will&#xD;
      be included during a 6-month enrollment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of cooperation and compliance&#xD;
  </why_stopped>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>No Device related Serious Adverse Event</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>No curve progression ˃10° above or below the implant</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">2</enrollment>
  <condition>Adolescent Idiopathic Scoliosis (AIS)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study is designed as a European, observational study with a 12-month follow-up period.&#xD;
        Consecutive patients undergoing treatment of AIS by the MID-C system in daily practice will&#xD;
        be included during a 6-month enrollment period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  11≤ Adolescents &lt; 20 years old&#xD;
&#xD;
          -  Patient undergoing treatment of AIS by the MID-C system in daily practice&#xD;
&#xD;
          -  Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5&#xD;
&#xD;
          -  Flexible major curve, correction to below 30° at lateral bending.&#xD;
&#xD;
          -  Risser sign of 1 to 5&#xD;
&#xD;
          -  Appropriate candidate for posterior surgical approach as determined by surgeon&#xD;
&#xD;
          -  Subject has good general health as determined by physician.&#xD;
&#xD;
          -  Subject has no known hypersensitivity and allergies to Titanium&#xD;
&#xD;
          -  Subject's guardian willing to sign a written Informed Consent Form (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cobb angle over 60 degrees&#xD;
&#xD;
          -  Other non-idiopathic scoliosis.&#xD;
&#xD;
          -  AIS which is not defined as Lenke type 1 or 5&#xD;
&#xD;
          -  Previous spine surgery.&#xD;
&#xD;
          -  Known allergy to any component of the device.&#xD;
&#xD;
          -  Known active systemic disease, such as AIDS, HIV, or active infection&#xD;
&#xD;
          -  Systemic disease that would affect the subject's welfare or overall outcome of the&#xD;
             study as determined by the physician.&#xD;
&#xD;
          -  Mentally compromised as determined by the physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JEAN-CHARLES LE HUEC, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unité d'Orthopédie-traumatologie, Rachis II</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unité d'Orthopédie-traumatologie, Rachis II</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2017</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>Scoliosis</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/NCT02200302
org study id: AF - 02
nct id: NCT02200302
lead sponsor: 
has dmc: No
Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the
      vertebrae and discs gradually develop a curvature that is first detected in patients between
      11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from
      radiographs by the Cobb angle .

      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each
      vertebra and disc between the superior and inferior end vertebrae . Although a small curve is
      well tolerated and does not require treatment, a large curve can progress to the point that
      it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac
      and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the
      initiation of the curve and its subsequent progression. The factors responsible for the
      initiation of the curve are unknown, but the subsequent progression of the curve is clearly
      associated with the adolescent growth spurt . The primary risk factors for progression
      include age at onset and the magnitude of the curve; young patients with large curves are at
      the highest risk .

      Although numerous treatment methods have been recommended for patients with AIS, the only
      accepted treatment includes bracing for skeletally immature patients with curves between 25
      and 40 degrees and operative correction with spinal fusion for patients with curves greater
      than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing
      has caused compliance problems with wearing the brace and many patients only wear the brace
      at home . While operative intervention completely corrects the scoliosis or rib hump, it
      eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion
      potentially leading to disc degeneration and back pain.

      Despite satisfactory short-term results of operative instrumentation and fusion, a less
      invasive technique preserving more motion with a smaller scar represents a major improvement.
      Realizing this goal is contingent on treating curves early, before they progress to an
      irreversible deformity, and when there is still enough residual growth and remodeling
      potential.

      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system
      is designed to correct the deformity step by step along a period of time, giving the skeletal
      and soft tissues time to accommodate any incremental correction.

      The MID-C System inherent benefits are:

        -  Only two screws are used

        -  Incision size is much smaller

        -  Simpler operation with shorter operative time

        -  Less complications (attributed to the three points above).

        -  Minimal spinal mobility loss.

      All the device components are made of materials well accepted in the orthopedic field and are
      fully biocompatible (see Investigator Brochure).

      The unique concept of the system and the materials used may provide favorable results as
      follows: Smaller scare, quicker healing period and better spine mobility over the years.

      This study is designed to demonstrate that the MID-C System is safe and effective.
The study is designed as a European, observational study with a 12-month follow-up period.
      Consecutive patients undergoing treatment of AIS by the MID-C system in daily practice will
      be included during a 6-month enrollment period.
observational model: Cohort
time perspective: Prospective
measure: No Device related Serious Adverse Event
time frame: 1 year
measure: No curve progression ˃10° above or below the implant
time frame: 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Years
maximum age: 20 Years
healthy volunteers: No
last name: JEAN-CHARLES LE HUEC, PD Dr. med.
role: Principal Investigator
affiliation: Unité d'Orthopédie-traumatologie, Rachis II
facility: 
country: France
country: United Kingdom
responsible party type: Sponsor
mesh term: Scoliosis