<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/NCT01687530</url>
  </required_header>
  <id_info>
    <org_study_id>REGO01/12</org_study_id>
    <nct_id>NCT01687530</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral Fractures</brief_title>
  <official_title>Randomised Controlled Trial to Evaluate the Safety Performance and Initial Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Proximal (Subtrochanteric) Femoral Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RegeneCure, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RegeneCure, Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Certain types of fractures require surgical intervention that may involve the use of bone&#xD;
      grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer&#xD;
      from disadvantages such as soft tissue invasion of the fracture area, inadequate blood&#xD;
      supply, failure to encourage the production of bone and ectopic bone formation.&#xD;
&#xD;
      A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR&#xD;
      has been widely used in the field of dentistry since the 1980s to provide stable placement&#xD;
      for dental implants&#xD;
&#xD;
      The purpose of this study is to evaluate the safety, performance and initial efficacy of&#xD;
      Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma&#xD;
      applications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <phase>Phase 1/Phase 2</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>To demonstrate the safety of the AMCA Bone membrane when used in the treatment of subtrochanteric femoral fractures.</measure>
    <time_frame>12 months</time_frame>
    <description>Safety element will be measured by evaluation of swelling, clinical signs of superficial or deep infection, pain in the operated area.&#xD;
Radiographic healing assessment score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union.</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy will be assessed by radiographic evaluation and functional assessment at different time points.&#xD;
To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union, assessed by a difference of ten points in reduction of the completed Harris hip score at 16 weeks from baseline.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union, assessed by a User Satisfaction</measure>
    <time_frame>12 months</time_frame>
    <description>User Satisfaction, Usability Lack of side effects Reduction of the incidences rate of secondary intervention</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Proximal (Subtrochanteric)Femoral Fractures</condition>
  <condition>Distal Femoral Fractures</condition>
  <arm_group>
    <arm_group_label>AMCA bone membrane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AMCA Bone is manufactured from Polyethylene Glycol 400 and Ammonio Methacrylate copolymer type A (Eudragit RL 100) materials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>AMCA Bone Membrane.</intervention_name>
    <description>AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.</description>
    <arm_group_label>AMCA bone membrane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 18 to 65 years&#xD;
&#xD;
          2. Both males and females&#xD;
&#xD;
          3. Females of child-bearing potential who have a negative urine hCG pregnancy test&#xD;
             following informed consent and prior to surgical procedure and who are not planning to&#xD;
             become pregnant for the duration of their part in the study&#xD;
&#xD;
          4. Femoral subtrochanteric fracture. The fracture is classified as one of the following:&#xD;
&#xD;
             A. Closed fracture B. AO 31 A3, 33b + C1 + C2, and extending to the distal third&#xD;
&#xD;
          5. Proximal subtrochanteric femoral fracture will be treated with a cephalomedullary&#xD;
             nail.&#xD;
&#xD;
          6. Patients must be available for follow-up for a minimum of 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Trauma presentation&#xD;
&#xD;
               -  Open fractures&#xD;
&#xD;
               -  Bilateral fractures&#xD;
&#xD;
               -  Polytrauma with head injury&#xD;
&#xD;
               -  Presence of periprosthetic fractures&#xD;
&#xD;
          2. Patient Medical History&#xD;
&#xD;
               -  Previous malignancy (except basal cell carcinoma of the skin)&#xD;
&#xD;
               -  Active autoimmune disease&#xD;
&#xD;
               -  Metabolic bone disease (primary or secondary)&#xD;
&#xD;
               -  Chronic renal insufficiency (defined by a Glomerular Filtration Rate of &lt;30&#xD;
                  ml/min)&#xD;
&#xD;
               -  Liver function abnormality (defined by presence of ALT or AST levels more than&#xD;
                  double the upper limit)&#xD;
&#xD;
               -  Current smoker&#xD;
&#xD;
          3. Concurrent medication&#xD;
&#xD;
             o Medications that may interfere with bone metabolism including:&#xD;
&#xD;
          4. Calcitonin for 7 days or more within the last 6 months prior to study&#xD;
&#xD;
          5. Bisphosphonates for 30 days or more within the last 12 months prior to study&#xD;
&#xD;
          6. Bone therapeutic doses of vitamin D or vitamin D metabolites for 30 days or more&#xD;
             within the last 6 months&#xD;
&#xD;
               -  Previous or present immunosuppressive treatment&#xD;
&#xD;
               -  Previous radiotherapy or chemotherapy&#xD;
&#xD;
               -  Cumulative dose of 150mg total prednisolone or any other gluco-corticosteroid for&#xD;
                  7 days or more within the last 6 months prior to study&#xD;
&#xD;
               -  Previous history of or current alcohol abuse&#xD;
&#xD;
               -  Previous history of or current drug addiction/abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amal Khoury, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah Medical Organization, Orthopedic Surgery Department</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Amal Khoury, M.D</last_name>
      <phone>972-2-6779549</phone>
      <email>akhoury@hadassah.org.il</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orthopedic Department, Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Amal Khoury</last_name>
      <phone>+97226779549</phone>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>August 26, 2013</last_update_submitted>
  <last_update_submitted_qc>August 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2013</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>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</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/NCT01687530
org study id: REGO01/12
nct id: NCT01687530
lead sponsor: 
has dmc: Yes
Certain types of fractures require surgical intervention that may involve the use of bone
      grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer
      from disadvantages such as soft tissue invasion of the fracture area, inadequate blood
      supply, failure to encourage the production of bone and ectopic bone formation.

      A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR
      has been widely used in the field of dentistry since the 1980s to provide stable placement
      for dental implants

      The purpose of this study is to evaluate the safety, performance and initial efficacy of
      Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma
      applications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To demonstrate the safety of the AMCA Bone membrane when used in the treatment of subtrochanteric femoral fractures.
time frame: 12 months
description: Safety element will be measured by evaluation of swelling, clinical signs of superficial or deep infection, pain in the operated area.
Radiographic healing assessment score.
measure: To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union.
time frame: 12 months
description: efficacy will be assessed by radiographic evaluation and functional assessment at different time points.
To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union, assessed by a difference of ten points in reduction of the completed Harris hip score at 16 weeks from baseline.
measure: To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union, assessed by a User Satisfaction
time frame: 12 months
description: User Satisfaction, Usability Lack of side effects Reduction of the incidences rate of secondary intervention
arm group label: AMCA bone membrane
arm group type: Experimental
description: AMCA Bone is manufactured from Polyethylene Glycol 400 and Ammonio Methacrylate copolymer type A (Eudragit RL 100) materials.
intervention type: Procedure
intervention name: AMCA Bone Membrane.
description: AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
arm group label: AMCA bone membrane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Amal Khoury, M.D
role: Study Director
affiliation: Hadassah Medical Organization
facility: 
contact: 
facility: 
contact: 
country: Israel
country: United Kingdom
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures