<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/NCT03777735</url>
  </required_header>
  <id_info>
    <org_study_id>OD1</org_study_id>
    <nct_id>NCT03777735</nct_id>
  </id_info>
  <brief_title>Human Bone Graft for Fixation of Osteochondral Defects in the Knee Joint</brief_title>
  <official_title>Multicentric Observational Study on the Use of a Human Bone Graft in Osteochondral Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Surgebright Gmbh</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</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>
      This observational study is to document the application of a human bone graft in the surgical&#xD;
      repair of bone fragment detachment in the knee joint (osteochondral defect) and its&#xD;
      subsequent healing process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the treatment of bone fractures metal screws have been used for decades. Removal of&#xD;
      material is the major disadvantage of conventional osteosynthesis and requires a second&#xD;
      intervention, with all the complications and risks for each patient. In order to avoid this&#xD;
      second surgery, it is possible to use human bone screw grafts instead of metal screws.&#xD;
&#xD;
      The bone graft helps to create a solid, bony connection. This connection leads to an&#xD;
      extension, a bone remodeling, bone installation and optimal reparation process in the&#xD;
      affected area.&#xD;
&#xD;
      The comparatively rare occurrence of suitable patients contributes to the fact that there has&#xD;
      not been enough systematic research to objectively confirm the benefits of the product, which&#xD;
      is why this observational study is being conducted.&#xD;
&#xD;
      In total, 20 patients will be enrolled in several centers in Austria. The low number of cases&#xD;
      and the multicenter design is due to the rarity of suitable patients.&#xD;
&#xD;
      This observational study will use Shark Screw® grafts without exception at all participating&#xD;
      centers. These grafts are manufactured by two tissue banks, the Austrian Tissue Bank&#xD;
      surgebright and the German Institute for Cell and Tissue Replacement (DZIG) and were approved&#xD;
      by the competent Austrian authority (AGES) in 2016.&#xD;
&#xD;
      All patients participating in this observational study, due to a medical indication, undergo&#xD;
      surgical treatment of osteochondral defects using the bone screws mentioned above.&#xD;
&#xD;
      Postoperatively, the patients are observed over a period of 24 months. In total, there are&#xD;
      five follow-up examinations during which clinical examinations, x-rays and a magnetic&#xD;
      resonance tomography (MRI) is performed. In addition the KOS-ADL and IKDC Score are&#xD;
      collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 24, 2018</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2023</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>incidence of surgical revisions</measure>
    <time_frame>1 year</time_frame>
    <description>Was a surgical revision done postoperatively? YES/NO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of loosening of the screw</measure>
    <time_frame>1 year</time_frame>
    <description>based on x-rays or MRI: Is a loosening of the screw visible? YES/NO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of cracking of the screw</measure>
    <time_frame>1 year</time_frame>
    <description>based on x-rays or MRI: Is a cracking of the screw visible? YES/NO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of loosening of the osteochondral fragment</measure>
    <time_frame>1 year</time_frame>
    <description>based on x-rays or MRI: Is a loosening of the osteochondral fragment visible? YES/NO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of cracking of the osteochondral fragment</measure>
    <time_frame>1 year</time_frame>
    <description>based on x-rays or MRI: Is a cracking of the osteochondral fragment visible? YES/NO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time to healing of the osteochondral fragment</measure>
    <time_frame>1 year</time_frame>
    <description>based on x-rays or MRI: Has the osteochondral fragment healed into the surrounding area? YES/NO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of postoperative pseudoarthrosis</measure>
    <time_frame>1 year</time_frame>
    <description>based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>evaluation postoperative pain (VAS)</measure>
    <time_frame>1 year</time_frame>
    <description>The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>duration of postoperative job-related incapacity</measure>
    <time_frame>1 year</time_frame>
    <description>evaluation of duration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction (VAS)</measure>
    <time_frame>1 year</time_frame>
    <description>The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = very satisfied - 100mm = not satisfied at all). A higher score indicates less satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)</measure>
    <time_frame>1 year</time_frame>
    <description>The KOS ADL score includes 14 questions and is divided in 2 subscales, symptoms (6 items, max. score 30) and functional restrictions (8 items, max. score 40). The scores of the answers range from 0 to 5 points. 0 points mean no impairment of everyday activities, while 5 points represent the greatest possible impairment. All points are summed up. From this, the KOS-ADL score is calculated as the proportion of the total response points from the possible maximum score (70) in percent. KOS ADL Score [%] = ( symptoms pts. + functional restrictions pts.)*100/70. The percentage ranges from 0-100%. 0% means no impairment, while 100% represents the greatest possible impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Knee Documentation Committee Subjective Knee Form (IKDC Score)</measure>
    <time_frame>1 year</time_frame>
    <description>The IKDC Score contains 19 questions (7 questions for symptomatology, 10 concerning function, 2 about sport activity). The lowest function level or the highest symptom level receives the score value 1. The highest function level or the lowest symptom level is given the number n according to the number n of possible answers. With the exception of question 10 &quot;Functioning before knee injury&quot;, the remaining 18 response points are summed up. This gives the &quot;raw sum&quot;. The lowest possible score is 18 and the maximum possible score is 87. The raw sum is converted into a scale of 0 to 100 using the following formula: ((raw score - lowest possible score)/score range)*100. 0 points mean the greatest possible impairment, while 100 points mean complete freedom from symptoms and functioning. The IKDC score can only be calculated if at least 16 of the 18 questions have been answered.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Osteochondral Defect</condition>
  <arm_group>
    <arm_group_label>human bone graft screw</arm_group_label>
    <description>The patients will receive human bone graft screws surgically.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>human bone graft screw</intervention_name>
    <description>All patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws.</description>
    <arm_group_label>human bone graft screw</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from all participating sites scheduled for an OD treatment with human bone graft&#xD;
        screws get information about this observational study and have the possibility to&#xD;
        participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for the use of a human bone graft in the surgical treatment of&#xD;
             osteochondral defects&#xD;
&#xD;
          -  legal capability of adults, guardians and adolescents aged 14 to 17 years,&#xD;
             age-appropriate perceptivity for children 8 to 13 years old&#xD;
&#xD;
          -  Written consent to participation in the study after previous written and oral&#xD;
             education (additional consent for participation of minors in the study after prior&#xD;
             written and oral education by at least one parent)&#xD;
&#xD;
          -  Age ≥ 8 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient knowledge of the German language&#xD;
&#xD;
          -  Alcohol and drug abuse&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Foreseeable compliance issues&#xD;
&#xD;
          -  Neoplastic diseases, malignant bone tumors, rheumatoid arthritis&#xD;
&#xD;
          -  Active osteomyelitis&#xD;
&#xD;
          -  Ulcerations in the area of the skin of the surgical area&#xD;
&#xD;
          -  Immunosuppressive drugs that can not be discontinued&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catharina Chiari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catharina Chiari, MD</last_name>
    <phone>+43140400</phone>
    <phone_ext>40900</phone_ext>
    <email>catharina.chiari@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sandra Hacker, MSc</last_name>
    <phone>+43140400</phone>
    <phone_ext>40900</phone_ext>
    <email>sandra.hacker@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>LKH-Univ.Klinikum Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Sperl, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barmherzige Schwestern Hospital Ried</name>
      <address>
        <city>Ried Im Innkreis</city>
        <zip>4910</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Norbert Freund, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>General Hospital Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Hacker, MSc</last_name>
      <phone>+43 1 40400</phone>
      <phone_ext>40900</phone_ext>
    </contact>
    <investigator>
      <last_name>Catharina Chiari, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Orthopedic Center Otto-Wagner-Spital</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Zenz, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Wels- Grieskirchen</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Klemens Trieb, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Catharina Chiari</investigator_full_name>
    <investigator_title>Univ. Prof. Dr. Catharina Chiari, MSc</investigator_title>
  </responsible_party>
  <keyword>human bone graft screw</keyword>
  <keyword>osteochondral defect</keyword>
  <keyword>knee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteochondrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03777735
org study id: OD1
nct id: NCT03777735
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study is to document the application of a human bone graft in the surgical
      repair of bone fragment detachment in the knee joint (osteochondral defect) and its
      subsequent healing process.
For the treatment of bone fractures metal screws have been used for decades. Removal of
      material is the major disadvantage of conventional osteosynthesis and requires a second
      intervention, with all the complications and risks for each patient. In order to avoid this
      second surgery, it is possible to use human bone screw grafts instead of metal screws.

      The bone graft helps to create a solid, bony connection. This connection leads to an
      extension, a bone remodeling, bone installation and optimal reparation process in the
      affected area.

      The comparatively rare occurrence of suitable patients contributes to the fact that there has
      not been enough systematic research to objectively confirm the benefits of the product, which
      is why this observational study is being conducted.

      In total, 20 patients will be enrolled in several centers in Austria. The low number of cases
      and the multicenter design is due to the rarity of suitable patients.

      This observational study will use Shark Screw® grafts without exception at all participating
      centers. These grafts are manufactured by two tissue banks, the Austrian Tissue Bank
      surgebright and the German Institute for Cell and Tissue Replacement (DZIG) and were approved
      by the competent Austrian authority (AGES) in 2016.

      All patients participating in this observational study, due to a medical indication, undergo
      surgical treatment of osteochondral defects using the bone screws mentioned above.

      Postoperatively, the patients are observed over a period of 24 months. In total, there are
      five follow-up examinations during which clinical examinations, x-rays and a magnetic
      resonance tomography (MRI) is performed. In addition the KOS-ADL and IKDC Score are
      collected.
observational model: Cohort
time perspective: Prospective
measure: incidence of surgical revisions
time frame: 1 year
description: Was a surgical revision done postoperatively? YES/NO
measure: incidence of loosening of the screw
time frame: 1 year
description: based on x-rays or MRI: Is a loosening of the screw visible? YES/NO
measure: incidence of cracking of the screw
time frame: 1 year
description: based on x-rays or MRI: Is a cracking of the screw visible? YES/NO
measure: incidence of loosening of the osteochondral fragment
time frame: 1 year
description: based on x-rays or MRI: Is a loosening of the osteochondral fragment visible? YES/NO
measure: incidence of cracking of the osteochondral fragment
time frame: 1 year
description: based on x-rays or MRI: Is a cracking of the osteochondral fragment visible? YES/NO
measure: time to healing of the osteochondral fragment
time frame: 1 year
description: based on x-rays or MRI: Has the osteochondral fragment healed into the surrounding area? YES/NO
measure: incidence of postoperative pseudoarthrosis
time frame: 1 year
description: based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO
measure: evaluation postoperative pain (VAS)
time frame: 1 year
description: The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.
measure: duration of postoperative job-related incapacity
time frame: 1 year
description: evaluation of duration
measure: patient satisfaction (VAS)
time frame: 1 year
description: The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = very satisfied - 100mm = not satisfied at all). A higher score indicates less satisfaction.
measure: Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)
time frame: 1 year
description: The KOS ADL score includes 14 questions and is divided in 2 subscales, symptoms (6 items, max. score 30) and functional restrictions (8 items, max. score 40). The scores of the answers range from 0 to 5 points. 0 points mean no impairment of everyday activities, while 5 points represent the greatest possible impairment. All points are summed up. From this, the KOS-ADL score is calculated as the proportion of the total response points from the possible maximum score (70) in percent. KOS ADL Score [%] = ( symptoms pts. + functional restrictions pts.)*100/70. The percentage ranges from 0-100%. 0% means no impairment, while 100% represents the greatest possible impairment.
measure: International Knee Documentation Committee Subjective Knee Form (IKDC Score)
time frame: 1 year
description: The IKDC Score contains 19 questions (7 questions for symptomatology, 10 concerning function, 2 about sport activity). The lowest function level or the highest symptom level receives the score value 1. The highest function level or the lowest symptom level is given the number n according to the number n of possible answers. With the exception of question 10 "Functioning before knee injury", the remaining 18 response points are summed up. This gives the "raw sum". The lowest possible score is 18 and the maximum possible score is 87. The raw sum is converted into a scale of 0 to 100 using the following formula: ((raw score - lowest possible score)/score range)*100. 0 points mean the greatest possible impairment, while 100 points mean complete freedom from symptoms and functioning. The IKDC score can only be calculated if at least 16 of the 18 questions have been answered.
arm group label: human bone graft screw
description: The patients will receive human bone graft screws surgically.
intervention type: Procedure
intervention name: human bone graft screw
description: All patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws.
arm group label: human bone graft screw
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 99 Years
healthy volunteers: No
last name: Catharina Chiari, MD
role: Principal Investigator
affiliation: Medical University Vienna
last name: Catharina Chiari, MD
phone: +43140400
phone ext: 40900
email: catharina.chiari@meduniwien.ac.at
last name: Sandra Hacker, MSc
phone: +43140400
phone ext: 40900
email: sandra.hacker@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Catharina Chiari
investigator title: Univ. Prof. Dr. Catharina Chiari, MSc
mesh term: Osteochondrosis
sharing ipd: No