<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/NCT01690260</url>
  </required_header>
  <id_info>
    <org_study_id>N-20040019</org_study_id>
    <nct_id>NCT01690260</nct_id>
  </id_info>
  <brief_title>Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment</brief_title>
  <official_title>Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern Orthopaedic Division, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Clinical and Basic Research (CCBR A/S).</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northern Orthopaedic Division, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional&#xD;
      ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local&#xD;
      application of BMP results in an increase of osseous tissue regardless of the location of the&#xD;
      growth factor.&#xD;
&#xD;
      5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and&#xD;
      improve clinical results when autologous bone graft is reduced or removed.&#xD;
&#xD;
      The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace&#xD;
      autologous bone graft in order to stimulating ossification during transplantation of osseous&#xD;
      tissue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2004</start_date>
  <completion_date type="Actual">October 2, 2017</completion_date>
  <primary_completion_date type="Actual">October 2, 2017</primary_completion_date>
  <phase>Phase 1</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visible radiological signs of healing after 6 months.</measure>
    <time_frame>An expected average of 6 months</time_frame>
    <description>Radiological signs of healing is a criteria for a successful result.&#xD;
Failure of healing after 6 months and/or a need for stimulant bone healing intervention can result in:&#xD;
Dynamic measurement af immobilization&#xD;
Ultrasound stimulation&#xD;
Re-surgery with application of bone graft or bone replacement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serologic bone markers</measure>
    <time_frame>An expected average of 6 months</time_frame>
    <description>Blood tests will be analyzed 1,2,3,4,6,9 and 12 months after operation in order to registrating a change in serologic bone markers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Bone Degenerative Changes</condition>
  <condition>Osteoarthritis</condition>
  <condition>Degenerative Disorder of Bone</condition>
  <arm_group>
    <arm_group_label>Bone Morphogenetic Protein 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Autologous bone graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Condition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bone Morphogenetic Protein 2</intervention_name>
    <description>12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.</description>
    <arm_group_label>Autologous bone graft</arm_group_label>
    <arm_group_label>Bone Morphogenetic Protein 2</arm_group_label>
    <other_name>No other names.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autologous bone graft</intervention_name>
    <description>Autologous bone graft in connection with bone docking operation.</description>
    <arm_group_label>Autologous bone graft</arm_group_label>
    <arm_group_label>Bone Morphogenetic Protein 2</arm_group_label>
    <other_name>No other names.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalised for autologous bone graft based on Ilizarow treatment.&#xD;
&#xD;
          -  Age between 20 and 70 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid osteoarthritis&#xD;
&#xD;
          -  Malignant disease&#xD;
&#xD;
          -  Current hormone treatment (glucocorticoid, parathyreoidea, thyreoidea)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Abuse of drugs and alcohol&#xD;
&#xD;
          -  Need of long-term NSAID treatment&#xD;
&#xD;
          -  Breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Knud S. Christensen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Donnell, Advisor</last_name>
    <role>Study Chair</role>
    <affiliation>Medtronic Inc., Watford</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans H. Hoeck, MD, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopaedic Surgery Research Unit, Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bone</keyword>
  <keyword>Morphogenetic</keyword>
  <keyword>Protein</keyword>
  <keyword>Ilizarow</keyword>
  <keyword>Autologous</keyword>
  <keyword>Osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Bone Diseases</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/NCT01690260
org study id: N-20040019
nct id: NCT01690260
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional
      ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local
      application of BMP results in an increase of osseous tissue regardless of the location of the
      growth factor.

      5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and
      improve clinical results when autologous bone graft is reduced or removed.

      The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace
      autologous bone graft in order to stimulating ossification during transplantation of osseous
      tissue.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visible radiological signs of healing after 6 months.
time frame: An expected average of 6 months
description: Radiological signs of healing is a criteria for a successful result.
Failure of healing after 6 months and/or a need for stimulant bone healing intervention can result in:
Dynamic measurement af immobilization
Ultrasound stimulation
Re-surgery with application of bone graft or bone replacement
measure: Change in serologic bone markers
time frame: An expected average of 6 months
description: Blood tests will be analyzed 1,2,3,4,6,9 and 12 months after operation in order to registrating a change in serologic bone markers.
arm group label: Bone Morphogenetic Protein 2
arm group type: Experimental
description: Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.
arm group label: Autologous bone graft
arm group type: Experimental
description: Condition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process.
intervention type: Drug
intervention name: Bone Morphogenetic Protein 2
description: 12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
arm group label: Autologous bone graft
arm group label: Bone Morphogenetic Protein 2
other name: No other names.
intervention type: Procedure
intervention name: Autologous bone graft
description: Autologous bone graft in connection with bone docking operation.
arm group label: Autologous bone graft
arm group label: Bone Morphogenetic Protein 2
other name: No other names.
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Knud S. Christensen, MD
role: Principal Investigator
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
last name: David Donnell, Advisor
role: Study Chair
affiliation: Medtronic Inc., Watford
last name: Hans H. Hoeck, MD, Ph.D.
role: Study Chair
affiliation: Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Bone Diseases