<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/NCT03836755</url>
  </required_header>
  <id_info>
    <org_study_id>33/18</org_study_id>
    <nct_id>NCT03836755</nct_id>
  </id_info>
  <brief_title>Evaluation of the Stability of Osseointegrated Implant in Amputees</brief_title>
  <acronym>METACOS</acronym>
  <official_title>Evaluation of the Stability of Osseointegrated Implant in Upper Limb or Lower Limb Amputees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Rizzoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Scuola Universitaria Superiore Sant'Anna Pisa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Ortopedico Rizzoli</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study concerns the technique of osseointegration that consists of inserting a titanium&#xD;
      pin into the bone of the amputated limb. A removable external prosthesis will then be&#xD;
      connected to the implant section that protrudes from the soft parts.&#xD;
&#xD;
      The benefits of using an osseointegrated prosthesis are the improved sensory feedback&#xD;
      (osseoperception) and absence of the socket. This leads to better anchoring of the prosthesis&#xD;
      to the abutment, greater control of the prosthesis and the absence of heat, pain, and&#xD;
      pressure sores.&#xD;
&#xD;
      The osseointegrated prosthesis does not reduce the mobility of the limb and promotes good&#xD;
      growth of bone and muscle mass. The aim of this study is to evaluate the stability of the&#xD;
      osseointegrated implant in trans-femoral and trans-humeral amputees.&#xD;
&#xD;
      The main outcome: quantitative evaluation (rotations, translation and MTPM) of the stability&#xD;
      of the implant bone interface by Roentgen Stereo-photogrammetric Analysis (RSA) and&#xD;
      follow-up.&#xD;
&#xD;
      The secondary outcome: evaluation of the quality of life improvement in patients through&#xD;
      clinical score and satisfaction survey.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rotation</measure>
    <time_frame>24 months</time_frame>
    <description>Rotations X, Y, Z (in degrees) of the implant with respect to the bone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Translation</measure>
    <time_frame>24 months</time_frame>
    <description>Translations X, Y, Z (in mm) of the implant with respect to the bone</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>24 months</time_frame>
    <description>36-Item Short Form Survey (SF36 )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain evaluation</measure>
    <time_frame>24 months</time_frame>
    <description>Visual Analog Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower limb: Autonomy</measure>
    <time_frame>24 months</time_frame>
    <description>Barthel Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lower limb: Mobility</measure>
    <time_frame>4 months</time_frame>
    <description>Rivermead Mobility Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper limb: functionality</measure>
    <time_frame>24 months</time_frame>
    <description>The Disabilities of the Arm, Shoulder and Hand (DASH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper Limb: Development and evaluation of the activities measure for upper limb amputees</measure>
    <time_frame>24 months</time_frame>
    <description>Activities Measure for Upper Limb Amputees (AM-ULA)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Prosthesis Migration</condition>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>METACOS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Required to do some motor tasks during static and dynamic RSA</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Metacos</intervention_name>
    <description>Evaluation of stability of implant by RSA technique</description>
    <arm_group_label>METACOS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI&lt;35 kg/m2&#xD;
&#xD;
          -  Problem in using socket&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes;&#xD;
&#xD;
          -  Peripheral vascular diseases;&#xD;
&#xD;
          -  Psychiatric problems;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Rheumatoid arthritis;&#xD;
&#xD;
          -  Neurovascular diseases;&#xD;
&#xD;
          -  Neurological deficits;&#xD;
&#xD;
          -  Amputation of the contralateral limb;&#xD;
&#xD;
          -  Infections in progress;&#xD;
&#xD;
          -  Immunosuppression;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Ortopedico Rizzoli</investigator_affiliation>
    <investigator_full_name>Stefano Zaffagnini</investigator_full_name>
    <investigator_title>Full Professor and Head of department</investigator_title>
  </responsible_party>
  <keyword>osseointegration</keyword>
  <keyword>implant migration</keyword>
  <keyword>amputee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prosthesis Failure</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/NCT03836755
org study id: 33/18
nct id: NCT03836755
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study concerns the technique of osseointegration that consists of inserting a titanium
      pin into the bone of the amputated limb. A removable external prosthesis will then be
      connected to the implant section that protrudes from the soft parts.

      The benefits of using an osseointegrated prosthesis are the improved sensory feedback
      (osseoperception) and absence of the socket. This leads to better anchoring of the prosthesis
      to the abutment, greater control of the prosthesis and the absence of heat, pain, and
      pressure sores.

      The osseointegrated prosthesis does not reduce the mobility of the limb and promotes good
      growth of bone and muscle mass. The aim of this study is to evaluate the stability of the
      osseointegrated implant in trans-femoral and trans-humeral amputees.

      The main outcome: quantitative evaluation (rotations, translation and MTPM) of the stability
      of the implant bone interface by Roentgen Stereo-photogrammetric Analysis (RSA) and
      follow-up.

      The secondary outcome: evaluation of the quality of life improvement in patients through
      clinical score and satisfaction survey.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Rotation
time frame: 24 months
description: Rotations X, Y, Z (in degrees) of the implant with respect to the bone
measure: Translation
time frame: 24 months
description: Translations X, Y, Z (in mm) of the implant with respect to the bone
measure: Health-related quality of life
time frame: 24 months
description: 36-Item Short Form Survey (SF36 )
measure: Pain evaluation
time frame: 24 months
description: Visual Analog Scale (VAS)
measure: Lower limb: Autonomy
time frame: 24 months
description: Barthel Index
measure: lower limb: Mobility
time frame: 4 months
description: Rivermead Mobility Index
measure: Upper limb: functionality
time frame: 24 months
description: The Disabilities of the Arm, Shoulder and Hand (DASH)
measure: Upper Limb: Development and evaluation of the activities measure for upper limb amputees
time frame: 24 months
description: Activities Measure for Upper Limb Amputees (AM-ULA)
arm group label: METACOS
arm group type: Other
description: Required to do some motor tasks during static and dynamic RSA
intervention type: Diagnostic Test
intervention name: Metacos
description: Evaluation of stability of implant by RSA technique
arm group label: METACOS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto Ortopedico Rizzoli
investigator full name: Stefano Zaffagnini
investigator title: Full Professor and Head of department
mesh term: Prosthesis Failure
sharing ipd: Undecided