<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/NCT01714999</url>
  </required_header>
  <id_info>
    <org_study_id>415-12</org_study_id>
    <secondary_id>1692/2012</secondary_id>
    <nct_id>NCT01714999</nct_id>
  </id_info>
  <brief_title>Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa</brief_title>
  <official_title>A Prospective Evaluation of the Current Treatment Regime for Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Following a recent publication by the authors [1], there is no standardized treatment regime&#xD;
      for the treatment of lacerations of the olecranon or prepatellar bursa, although primary&#xD;
      bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland.&#xD;
      The aim of this study is to prospectively follow patients who suffered from an acute&#xD;
      traumatic laceration of the OB or PB treated, according to the local standards, either by&#xD;
      bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).&#xD;
&#xD;
      [1] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and&#xD;
      Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A fall onto the elbow or knee often results in a laceration of the olecranon (OB) and&#xD;
      prepatellar bursa (PB), due to their exposed and superficial location. Although a common&#xD;
      injury, the authors are not aware of any study dealing with this entity. In order to get a&#xD;
      first idea on the treatment concepts currently used, the authors conducted a international&#xD;
      online survey among orthopaedic and trauma surgeons in Germany, Austria and Switzerland [1].&#xD;
      The primary treatment approach of more than 70% of Austrian and German surgeons was&#xD;
      bursectomy and immobilization, which was performed by less than 50% of Swiss physicians.&#xD;
&#xD;
      At the Departments of Trauma Surgery of the Medical University of Vienna and of the Medical&#xD;
      University of Munich, two opposing treatment concepts are being practised. Whereas in Vienna&#xD;
      a bursectomy is performed in case of traumatic laceration of the OB and PB, a primary bursal&#xD;
      reconstruction is performed at the Medical University of Munich.&#xD;
&#xD;
      The aim of this study is to prospectively follow patients who suffered from an acute&#xD;
      traumatic laceration of the OB or PB treated, according to the local standards, either by&#xD;
      bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).&#xD;
&#xD;
      The Hypothesis of this study is, that there is no difference with respect to complications&#xD;
      between bursectomy and bursal reconstruction in case of acute traumatic laceration of the OB&#xD;
      and PB.&#xD;
&#xD;
      1. Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and&#xD;
      Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound infection</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bursitis</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment costs of a standard patient</measure>
    <time_frame>6 weeks / 12 month</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Traumatic Laceration of the Olecranon or Prepatellar Bursa</condition>
  <arm_group>
    <arm_group_label>Bursectomy: Vienna</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the Department of Trauma Surgery, Medical University of Vienna, bursectomy is considered the gold standard in case of traumatic laceration of the OB or PB bursa.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bursal reconstruction: Munich</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the Department of Trauma Surgery, Medical University of Munich, the treatment regime is a primary bursa-preserving therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bursectomy</intervention_name>
    <description>Bursectomy of the OB and PB are performed in the operation theatre under sterile conditions. In case of a laceration of the OB a leash, in case of PB a redon drainage (Charr. 10) is inserted. After application of a sterile bandage a cast is applied in both cases. Patient will receive AB for 5 days, the affected limb will be immobilized until removal of the stiches after 12-14 days.</description>
    <arm_group_label>Bursectomy: Vienna</arm_group_label>
    <other_name>Removal of the Bursa, Excision of the Bursa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bursal reconstruction</intervention_name>
    <description>The bursal laceration is treated within in ER setting. The wound is cleaned and thoroughly washed, if needed the wound margins are excised. The wound is then closed using simple suture and a plaster applied and removed 5 days later. Antibiotics are be administered for 5 days</description>
    <arm_group_label>Bursal reconstruction: Munich</arm_group_label>
    <other_name>Reconstruction of the bursa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute lacerations of the OB or PB (&lt;12h)&#xD;
&#xD;
          -  Age 18 - 60 years&#xD;
&#xD;
          -  Patient can read and understand German&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunodeficient patients&#xD;
&#xD;
          -  Severe dementia&#xD;
&#xD;
          -  Chronic alcoholism&#xD;
&#xD;
          -  Conditions affecting the neuromuscular- or musculoskeletal system&#xD;
&#xD;
          -  Previous surgical interventions at the same joint&#xD;
&#xD;
          -  Conditions affecting wound healing (including chronic alcoholism, insulin dependent&#xD;
             diabetes&#xD;
&#xD;
          -  Neurological diseases&#xD;
&#xD;
          -  Patient is not available for follow-up visits&#xD;
&#xD;
          -  Patient suspected to be non-compliant&#xD;
&#xD;
          -  No major concomitant injuries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian F Baumbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians - University of Munich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vikoria Bogner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians - University of Munich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sebastian F Baumbach, M.D.</last_name>
    <email>sebastian.baumbach@med.uni-muenchen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Trauma Surgery, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Florian Domaszewski, M.D.</last_name>
      <email>florian.domaszewski@meduniwien.ac.at</email>
    </contact>
    <investigator>
      <last_name>Florian Domaszewski, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Trauma Surgery, Medical University of Munich</name>
      <address>
        <city>Munich</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sebastian F. Baumbach, M.D.</last_name>
      <email>sebastian.baumbach@med.uni-muenchen.de</email>
    </contact>
    <investigator>
      <last_name>Sebastian F. Baumbach, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Baumbach SF, Domaszewski F, Wyen H, Kalcher K, Mutschler W, Kanz KG. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury. 2013 Nov;44(11):1423-7. doi: 10.1016/j.injury.2012.08.008. Epub 2012 Sep 11.</citation>
    <PMID>22980398</PMID>
  </reference>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 14, 2014</last_update_submitted>
  <last_update_submitted_qc>April 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Sebastian. F. Baumbach</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>olecranon</keyword>
  <keyword>prepatellar</keyword>
  <keyword>bursa</keyword>
  <keyword>trauma</keyword>
  <keyword>laceration</keyword>
  <keyword>bursectomy</keyword>
  <keyword>bursa reconstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacerations</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/NCT01714999
org study id: 415-12
secondary id: 1692/2012
nct id: NCT01714999
lead sponsor: 
has dmc: No
Following a recent publication by the authors [1], there is no standardized treatment regime
      for the treatment of lacerations of the olecranon or prepatellar bursa, although primary
      bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland.
      The aim of this study is to prospectively follow patients who suffered from an acute
      traumatic laceration of the OB or PB treated, according to the local standards, either by
      bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).

      [1] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and
      Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)
A fall onto the elbow or knee often results in a laceration of the olecranon (OB) and
      prepatellar bursa (PB), due to their exposed and superficial location. Although a common
      injury, the authors are not aware of any study dealing with this entity. In order to get a
      first idea on the treatment concepts currently used, the authors conducted a international
      online survey among orthopaedic and trauma surgeons in Germany, Austria and Switzerland [1].
      The primary treatment approach of more than 70% of Austrian and German surgeons was
      bursectomy and immobilization, which was performed by less than 50% of Swiss physicians.

      At the Departments of Trauma Surgery of the Medical University of Vienna and of the Medical
      University of Munich, two opposing treatment concepts are being practised. Whereas in Vienna
      a bursectomy is performed in case of traumatic laceration of the OB and PB, a primary bursal
      reconstruction is performed at the Medical University of Munich.

      The aim of this study is to prospectively follow patients who suffered from an acute
      traumatic laceration of the OB or PB treated, according to the local standards, either by
      bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).

      The Hypothesis of this study is, that there is no difference with respect to complications
      between bursectomy and bursal reconstruction in case of acute traumatic laceration of the OB
      and PB.

      1. Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and
      Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Wound infection
time frame: 6 weeks
measure: Bursitis
time frame: 12 month
measure: Treatment costs of a standard patient
time frame: 6 weeks / 12 month
arm group label: Bursectomy: Vienna
arm group type: Experimental
description: At the Department of Trauma Surgery, Medical University of Vienna, bursectomy is considered the gold standard in case of traumatic laceration of the OB or PB bursa.
arm group label: Bursal reconstruction: Munich
arm group type: Experimental
description: At the Department of Trauma Surgery, Medical University of Munich, the treatment regime is a primary bursa-preserving therapy.
intervention type: Procedure
intervention name: Bursectomy
description: Bursectomy of the OB and PB are performed in the operation theatre under sterile conditions. In case of a laceration of the OB a leash, in case of PB a redon drainage (Charr. 10) is inserted. After application of a sterile bandage a cast is applied in both cases. Patient will receive AB for 5 days, the affected limb will be immobilized until removal of the stiches after 12-14 days.
arm group label: Bursectomy: Vienna
other name: Removal of the Bursa, Excision of the Bursa
intervention type: Procedure
intervention name: Bursal reconstruction
description: The bursal laceration is treated within in ER setting. The wound is cleaned and thoroughly washed, if needed the wound margins are excised. The wound is then closed using simple suture and a plaster applied and removed 5 days later. Antibiotics are be administered for 5 days
arm group label: Bursal reconstruction: Munich
other name: Reconstruction of the bursa
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sebastian F Baumbach, MD
role: Principal Investigator
affiliation: Ludwig-Maximilians - University of Munich
last name: Vikoria Bogner, MD
role: Principal Investigator
affiliation: Ludwig-Maximilians - University of Munich
last name: Sebastian F Baumbach, M.D.
email: sebastian.baumbach@med.uni-muenchen.de
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Austria
country: Germany
citation: Baumbach SF, Domaszewski F, Wyen H, Kalcher K, Mutschler W, Kanz KG. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury. 2013 Nov;44(11):1423-7. doi: 10.1016/j.injury.2012.08.008. Epub 2012 Sep 11.
PMID: 22980398
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Sebastian. F. Baumbach
investigator title: M.D.
mesh term: Lacerations