<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/NCT01725711</url>
  </required_header>
  <id_info>
    <org_study_id>R402-98</org_study_id>
    <nct_id>NCT01725711</nct_id>
  </id_info>
  <brief_title>Osseointegrated Prostheses for the Rehabilitation of Amputees</brief_title>
  <acronym>OPRA</acronym>
  <official_title>Osseointegrated Prostheses for the Rehabilitation of Amputees.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integrum</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Integrum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with transfemoral amputations (TFA) frequently experience problems related to the&#xD;
      use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps&#xD;
      4. The potential for improvement is substantial. Based on the very good long-term results&#xD;
      with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing&#xD;
      aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the&#xD;
      clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg,&#xD;
      Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical&#xD;
      trial began.&#xD;
&#xD;
      The hypothesis is that the treatment will improve quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>May 1999</start_date>
  <completion_date type="Anticipated">May 2027</completion_date>
  <primary_completion_date type="Anticipated">May 2027</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Q-TFA Prosthetic Use Score</measure>
    <time_frame>0,1,2,3,5,7,10,15,20 years</time_frame>
    <description>The primary efficacy variable is the change in Q-TFA Prosthetic Use Score as compared baseline.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Transfemoral Amputation</condition>
  <arm_group>
    <arm_group_label>Implant System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OPRA Implant System</intervention_name>
    <arm_group_label>Implant System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Transfemoral amputation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transfemoral amputation due to vascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <state>VG</state>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</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/NCT01725711
org study id: R402-98
nct id: NCT01725711
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Patients with transfemoral amputations (TFA) frequently experience problems related to the
      use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps
      4. The potential for improvement is substantial. Based on the very good long-term results
      with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing
      aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the
      clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg,
      Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical
      trial began.

      The hypothesis is that the treatment will improve quality of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Q-TFA Prosthetic Use Score
time frame: 0,1,2,3,5,7,10,15,20 years
description: The primary efficacy variable is the change in Q-TFA Prosthetic Use Score as compared baseline.
arm group label: Implant System
arm group type: Experimental
intervention type: Device
intervention name: OPRA Implant System
arm group label: Implant System
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Sponsor