<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/NCT02193841</url>
  </required_header>
  <id_info>
    <org_study_id>1000042364</org_study_id>
    <nct_id>NCT02193841</nct_id>
  </id_info>
  <brief_title>Simple Bone Cysts in Kids</brief_title>
  <acronym>SBoCK</acronym>
  <official_title>Simple Bone Cysts in Kids (SBoCK)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long&#xD;
      bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one&#xD;
      is better than another. The purpose of this research trial is to compare the effectiveness of&#xD;
      two common treatments that are used by surgeons today.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In general, few randomized clinical trials have been undertaken in paediatric orthopaedics,&#xD;
      and only one to date has addressed the problem of simple bone cysts (SBCs). Also known as&#xD;
      unicameral bone cysts, they are the commonest bone lesion in children. Despite general&#xD;
      opinion, these cysts do not resolve at skeletal maturity.&#xD;
&#xD;
      Many forms of treatment have been recommended but none, including the popular methods of&#xD;
      corticosteroid or bone marrow injections, have reliably eradicated SBC. Although the lesions&#xD;
      are considered benign (non-cancerous), they cause pain, frequently interfere with function,&#xD;
      dramatically restrict play activity, may re-fracture leading to growth arrest and/or&#xD;
      deformity, and cause enormous anxiety for children and their families.&#xD;
&#xD;
      With a well-developed network of surgeons and researchers, we will provide evidence comparing&#xD;
      the effectiveness of two treatment interventions for SBC. More specifically, our goals for&#xD;
      this study are:&#xD;
&#xD;
        1. to compare the rate of radiographic healing between two standard treatments including&#xD;
           curettage with puncture alone, and curettage with puncture followed by injection with&#xD;
           Vitoss morsels;&#xD;
&#xD;
        2. to identify prognostic radiographic factors associated with simple bone cyst healing and&#xD;
           fracture;&#xD;
&#xD;
        3. to determine the impact of simple bone cyst on children/family functioning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">March 2027</completion_date>
  <primary_completion_date type="Anticipated">March 2027</primary_completion_date>
  <phase>Phase 3</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cyst healing</measure>
    <time_frame>2 years</time_frame>
    <description>Healing will be graded according to a 4-point modified Neer's classification by radiologists</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical measures (Cyst features)</measure>
    <time_frame>1 and 2 years</time_frame>
    <description>Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional measures (Questionnaire scores)</measure>
    <time_frame>1 and 2 years</time_frame>
    <description>Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Bone Cyst</condition>
  <arm_group>
    <arm_group_label>C &amp; P</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Curettage with puncture (C &amp; P) will be performed alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C &amp; P with Vitoss</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C &amp; P)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Curettage with puncture (C &amp; P)</intervention_name>
    <description>A curette will be inserted to scrape the contents of the cyst (curettage) and a hole in the cyst wall will be made (puncture) near the bone marrow cavity</description>
    <arm_group_label>C &amp; P</arm_group_label>
    <arm_group_label>C &amp; P with Vitoss</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Curette</intervention_name>
    <description>A small surgical instrument with a rounded edge designed for scraping</description>
    <arm_group_label>C &amp; P</arm_group_label>
    <arm_group_label>C &amp; P with Vitoss</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vitoss morsels</intervention_name>
    <description>A bone substitute intended for use as a filler for voids or gaps in bones</description>
    <arm_group_label>C &amp; P with Vitoss</arm_group_label>
    <other_name>Tri-calcium phosphate bone graft substitute</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a confirmed simple bone cyst in a long bone (ie. arm or leg) within last&#xD;
             3 months&#xD;
&#xD;
          -  At least 3 weeks must have elapsed since last fracture&#xD;
&#xD;
          -  At least 3 months must have elapsed since last cyst treatment&#xD;
&#xD;
          -  Patients and/or their legal representatives willing to provide written informed&#xD;
             consent (and assent, when appropriate)&#xD;
&#xD;
          -  Patients with stabilizing implants in the bone where the cyst is located&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with bone disease (ie. osteogenesis imperfecta, cancer, osteoporosis, Paget's&#xD;
             disease)&#xD;
&#xD;
          -  Pregnant or breastfeeding female&#xD;
&#xD;
          -  Patients with cysts crossing the growth plate (area where bone grows)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James G. Wright</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sevan Hopyan</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Project Manager</last_name>
    <email>sbock.study@sickkids.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children's Hospital of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Loma Linda University</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabeth Clarke</last_name>
      <email>EAClarke@llu.edu</email>
    </contact>
    <investigator>
      <last_name>Martin Morrison III</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nemours/Alfred I. duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carly Strohbach</last_name>
      <email>cstrohbach@luriechildrens.org</email>
    </contact>
    <contact_backup>
      <last_name>Jamie Burgess</last_name>
      <email>jburgess@luriechildrens.org</email>
    </contact_backup>
    <investigator>
      <last_name>Joseph A Janicki</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The John Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at Montefiore</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital for Joint Diseases</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of North Carolina - Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Titter</last_name>
      <email>julie_titter@med.unc.edu</email>
    </contact>
    <investigator>
      <last_name>Anna Vergun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grace Anand</last_name>
      <email>gxanand@texaschildrens.org</email>
    </contact>
    <investigator>
      <last_name>Vinitha R Shenava</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Royal Children's Hospital</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Formosa</last_name>
      <email>melissa.formosa@mcri.edu.au</email>
    </contact>
    <investigator>
      <last_name>Brian Loh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yoga Dhanapala</last_name>
      <email>yndhanap@ucalgary.ca</email>
    </contact>
    <investigator>
      <last_name>Elaine Joughin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BC Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harpreet Chhina</last_name>
      <email>HChhina@cw.bc.ca</email>
    </contact>
    <contact_backup>
      <email>HChhina@cw.bc.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Tony Cooper</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kishore Mulpuri</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Winnipeg Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Hurry</last_name>
      <email>Jennifer.Hurry@iwk.nshealth.ca</email>
    </contact>
    <investigator>
      <last_name>Karl Logan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital at London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacob Davidson</last_name>
      <email>Jacob.Davidson@lhsc.on.ca</email>
    </contact>
    <investigator>
      <last_name>Debra Bartley</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Holly Livock</last_name>
      <email>HLivock@cheo.on.ca</email>
    </contact>
    <investigator>
      <last_name>Sasha Carsen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Shiu</last_name>
      <email>julie.shiu@sickkids.ca</email>
    </contact>
    <investigator>
      <last_name>Sevan Hopyan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shriners Hospital for Children - Canadian Unit</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Alder Hey Children's Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L12 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emma Spink</last_name>
      <email>emma.spink@alderhey.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Dan Perry</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital for Children</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kim Gardiner</last_name>
      <email>kim.gardiner@gosh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Andreas Roposch</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Manchester Children's Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Imelda Mayor</last_name>
      <email>imelda.mayor@mft.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Mohamed Kenawey</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nuffield Orthopaedic Centre</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca Harmer</last_name>
      <email>rebecca.harmer@ouh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Tim Theologis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sheffield Children's Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aimee Corcoran</last_name>
      <email>aimee.corcoran@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Nicolas Nicolaou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Qatar</country>
  </removed_countries>
  <link>
    <url>http://www.sickkids.ca/research/sbock/</url>
    <description>SBoCK Trial Website</description>
  </link>
  <reference>
    <citation>Wright JG, Yandow S, Donaldson S, Marley L; Simple Bone Cyst Trial Group. A randomized clinical trial comparing intralesional bone marrow and steroid injections for simple bone cysts. J Bone Joint Surg Am. 2008 Apr;90(4):722-30. doi: 10.2106/JBJS.G.00620.</citation>
    <PMID>18381307</PMID>
  </reference>
  <reference>
    <citation>Donaldson S, Wright JG. Recent developments in treatment for simple bone cysts. Curr Opin Pediatr. 2011 Feb;23(1):73-7. doi: 10.1097/MOP.0b013e3283421111.</citation>
    <PMID>21191299</PMID>
  </reference>
  <reference>
    <citation>Canavese F, Wright JG, Cole WG, Hopyan S. Unicameral bone cysts: comparison of percutaneous curettage, steroid, and autologous bone marrow injections. J Pediatr Orthop. 2011 Jan-Feb;31(1):50-5. doi: 10.1097/BPO.0b013e3181ff7510.</citation>
    <PMID>21150732</PMID>
  </reference>
  <reference>
    <citation>Donaldson S, Chundamala J, Yandow S, Wright JG. Treatment for unicameral bone cysts in long bones: an evidence based review. Orthop Rev (Pavia). 2010 Mar 20;2(1):e13. doi: 10.4081/or.2010.e13.</citation>
    <PMID>21808696</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>James Wright</investigator_full_name>
    <investigator_title>Orthopaedic Surgeon</investigator_title>
  </responsible_party>
  <keyword>Simple bone cyst</keyword>
  <keyword>Unicameral bone cyst</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Bone Cysts</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_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/NCT02193841
org study id: 1000042364
nct id: NCT02193841
lead sponsor: 
collaborator: 
has dmc: Yes
Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long
      bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one
      is better than another. The purpose of this research trial is to compare the effectiveness of
      two common treatments that are used by surgeons today.
In general, few randomized clinical trials have been undertaken in paediatric orthopaedics,
      and only one to date has addressed the problem of simple bone cysts (SBCs). Also known as
      unicameral bone cysts, they are the commonest bone lesion in children. Despite general
      opinion, these cysts do not resolve at skeletal maturity.

      Many forms of treatment have been recommended but none, including the popular methods of
      corticosteroid or bone marrow injections, have reliably eradicated SBC. Although the lesions
      are considered benign (non-cancerous), they cause pain, frequently interfere with function,
      dramatically restrict play activity, may re-fracture leading to growth arrest and/or
      deformity, and cause enormous anxiety for children and their families.

      With a well-developed network of surgeons and researchers, we will provide evidence comparing
      the effectiveness of two treatment interventions for SBC. More specifically, our goals for
      this study are:

        1. to compare the rate of radiographic healing between two standard treatments including
           curettage with puncture alone, and curettage with puncture followed by injection with
           Vitoss morsels;

        2. to identify prognostic radiographic factors associated with simple bone cyst healing and
           fracture;

        3. to determine the impact of simple bone cyst on children/family functioning.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Cyst healing
time frame: 2 years
description: Healing will be graded according to a 4-point modified Neer's classification by radiologists
measure: Clinical measures (Cyst features)
time frame: 1 and 2 years
description: Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
measure: Functional measures (Questionnaire scores)
time frame: 1 and 2 years
description: Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
arm group label: C & P
arm group type: Active Comparator
description: Curettage with puncture (C & P) will be performed alone
arm group label: C & P with Vitoss
arm group type: Active Comparator
description: A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C & P)
intervention type: Procedure
intervention name: Curettage with puncture (C & P)
description: A curette will be inserted to scrape the contents of the cyst (curettage) and a hole in the cyst wall will be made (puncture) near the bone marrow cavity
arm group label: C & P
arm group label: C & P with Vitoss
intervention type: Device
intervention name: Curette
description: A small surgical instrument with a rounded edge designed for scraping
arm group label: C & P
arm group label: C & P with Vitoss
intervention type: Device
intervention name: Vitoss morsels
description: A bone substitute intended for use as a filler for voids or gaps in bones
arm group label: C & P with Vitoss
other name: Tri-calcium phosphate bone graft substitute
criteria: 
gender: All
minimum age: 2 Years
maximum age: 21 Years
healthy volunteers: No
last name: James G. Wright
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Sevan Hopyan
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Project Manager
email: sbock.study@sickkids.ca
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Australia
country: Canada
country: United Kingdom
country: United States
country: Qatar
url: http://www.sickkids.ca/research/sbock/
description: SBoCK Trial Website
citation: Wright JG, Yandow S, Donaldson S, Marley L; Simple Bone Cyst Trial Group. A randomized clinical trial comparing intralesional bone marrow and steroid injections for simple bone cysts. J Bone Joint Surg Am. 2008 Apr;90(4):722-30. doi: 10.2106/JBJS.G.00620.
PMID: 18381307
citation: Donaldson S, Wright JG. Recent developments in treatment for simple bone cysts. Curr Opin Pediatr. 2011 Feb;23(1):73-7. doi: 10.1097/MOP.0b013e3283421111.
PMID: 21191299
citation: Canavese F, Wright JG, Cole WG, Hopyan S. Unicameral bone cysts: comparison of percutaneous curettage, steroid, and autologous bone marrow injections. J Pediatr Orthop. 2011 Jan-Feb;31(1):50-5. doi: 10.1097/BPO.0b013e3181ff7510.
PMID: 21150732
citation: Donaldson S, Chundamala J, Yandow S, Wright JG. Treatment for unicameral bone cysts in long bones: an evidence based review. Orthop Rev (Pavia). 2010 Mar 20;2(1):e13. doi: 10.4081/or.2010.e13.
PMID: 21808696
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: James Wright
investigator title: Orthopaedic Surgeon
mesh term: Cysts
mesh term: Bone Cysts
mesh term: Calcium