<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/NCT03302533</url>
  </required_header>
  <id_info>
    <org_study_id>001-2017</org_study_id>
    <nct_id>NCT03302533</nct_id>
  </id_info>
  <brief_title>Can Secondary Total Elbow Arthroplasty After Failed Internal Fixation or Non-operative Treatment of Distal Humeral Fractures Achieve Equal Results as Primary Arthroplasty?</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diakoniekrankenhaus Friederikenstift</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diakoniekrankenhaus Friederikenstift</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Total elbow arthroplasty (TEA) results in immediate pain release with good functional results&#xD;
      after distal humerus fractures. But still open reduction and internal fixation is recommended&#xD;
      as treatment of choise due to a lifelong loading limitiation, unknown implant survival and&#xD;
      problematic revision surgery after TEA. The purpose of this study was to compare functional&#xD;
      results and complication rates after primary total elbow arthroplasty (TEA) and TEA after&#xD;
      failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal&#xD;
      humerus fractures. We hypothesised that clinical and functional results are better for&#xD;
      primary TEA with less complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total elbow arthroplasty (TEA) results in immediate pain release with good functional results&#xD;
      after distal humerus fractures. But still open reduction and internal fixation is recommended&#xD;
      as treatment of choise due to a lifelong loading limitiation, unknown implant survival and&#xD;
      problematic revision surgery after TEA. The purpose of this study was to compare functional&#xD;
      results and complication rates after primary total elbow arthroplasty (TEA) and TEA after&#xD;
      failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal&#xD;
      humerus fractures.&#xD;
&#xD;
      This retrospective study was performed at a level I trauma centre. All patients were informed&#xD;
      about the study and provided written informed consent.&#xD;
&#xD;
      All patients undergoing total elbow arthroplasty (TEA) were identified by electronically&#xD;
      screening our database by the OPS codes 5-824.4 (implantation of a linked TEA) and 5-824.5&#xD;
      (implantation of an unlinked TEA) between August 2008 and May 2014. Based on patient records&#xD;
      and x-rays the indication for implantation of the TEA was retrospectively reviewed. All&#xD;
      patients, who received a TEA for an acute trauma with fracture of the distal humerus (primary&#xD;
      TEA) or due to a failed reconstruction or non-operative treatment after a distal humerus&#xD;
      fracture (secondary TEA), were included in this study. A minimum follow-up of 6 months was&#xD;
      set as inclusion criterion. Exclusion criteria were previous injury at the fractured elbow,&#xD;
      neuro-muscular disease, cortisone or other immune suppressive therapy and open fracture grade&#xD;
      II or higher according to Tscherne and Ostern.The patient records were reviewed for&#xD;
      demographic and perioperative data. If the initial treatment was not conducted in our&#xD;
      department, radiographs and patient records were requested. The follow-up examination&#xD;
      included the evaluation of the range of motion and stability of the elbow, actual pain and&#xD;
      satisfaction of the patient. To objectify the functional result the Mayo Elbow Performance&#xD;
      Score (MEPS) and Disabilities of the Arm, Shoulder and Hand Score (DASH) were determined.&#xD;
      Additionally, complications and revision surgeries were recorded. Complications were split up&#xD;
      into minor (nerve irritation or postoperative haematoma) and major complications, which&#xD;
      required a revision of the prosthesis. Periprosthetic fractures due to renewed fall with an&#xD;
      adequate trauma were not counted as complication.&#xD;
&#xD;
      Perioperative data, the functional result (range of motion, MEPS, DASH) and postoperative&#xD;
      complications were described for each group. Subsequently, these results were statistically&#xD;
      compared using the Mann-Whitney U test as a two-way analysis of variance for independent&#xD;
      factors. A p-value ≤ 0.05 was considered statistically significant. The statistical analysis&#xD;
      was performed using SPSS for MAC (IBM SPSS Statistics 22, Chicago, Illinois).&#xD;
&#xD;
      We hypothesised that clinical and functional results are better for primary TEA with less&#xD;
      complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2013</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>minimum follow-up: 6 months</time_frame>
    <description>Measurement of the range of motion for extension/flexion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mayo Elbow Performance Score</measure>
    <time_frame>minimum follow-up: 6 months</time_frame>
    <description>Objective score evaluation the function of the elbow</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication</measure>
    <time_frame>minimum follow-up: 6 months</time_frame>
    <description>appearance of a complication</description>
  </secondary_outcome>
  <other_outcome>
    <measure>DASH score</measure>
    <time_frame>minimum follow-up: 6 months</time_frame>
    <description>Disabilities of the Arm, Shoulder and Hand: subjective score evaluation the function</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Elbow Fracture</condition>
  <condition>Elbow Arthropathy</condition>
  <arm_group>
    <arm_group_label>Primary arthroplasty</arm_group_label>
    <description>All patients who received TEA for an acute trauma with fracture of the distal humerus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary arthroplasty</arm_group_label>
    <description>All patients who received TEA due to a failed reconstruction or non-operative treatment after a distal humerus fracture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total elbow arthroplasty</intervention_name>
    <description>Implantation of a total elbow arthroplasty after distal humerus fracture</description>
    <arm_group_label>Primary arthroplasty</arm_group_label>
    <arm_group_label>Secondary arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Out of 35 patients, who fit the inclusion criteria, six had died from unrelated causes. 23&#xD;
        patients participated in the study, since six patients were lost to follow-up. Nine of the&#xD;
        23 patients (mean age: 70 years; 8 women) had implantation of a primary TEA. The remaining&#xD;
        14 patients (mean age: 63 years; 11 women) received secondary implantation of a TEA. The&#xD;
        secondary TEA was implanted after an implant failure in four patients, twice because of a&#xD;
        non-union (one after reconstruction and one after non-operative therapy), and in three&#xD;
        patients because of a non-union with an additional partial necrosis of the distal humerus.&#xD;
        Two patients received secondary TEA because of a posttraumatic arthritis after internal&#xD;
        fixation and three times because of a posttraumatic arthritis after non-operative&#xD;
        treatment. The mean follow-up was 28 months (range: 6 - 73) with a mean age of 66 years&#xD;
        (range: 41 - 85).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Minimum age: 18 years Sex: All&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Total elbow arthroplasty for an acute trauma with fracture due to an acute trauma&#xD;
&#xD;
          -  Total elbow arthroplasty due to failed reconstruction after distal humerus fracture&#xD;
&#xD;
          -  Total elbow arthroplasty after non-operatic treatment after distal humerus fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous injury at the fractured elbow&#xD;
&#xD;
          -  neuro-muscular disease&#xD;
&#xD;
          -  cortisone or other immune suppressive therapy&#xD;
&#xD;
          -  open fracture grade II or higher according to Tscherne and Ostern&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</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>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diakoniekrankenhaus Friederikenstift</investigator_affiliation>
    <investigator_full_name>Dr. Alexander Ellwein</investigator_full_name>
    <investigator_title>Assistant Physician</investigator_title>
  </responsible_party>
  <keyword>distal humerus fracture</keyword>
  <keyword>total elbow arthroplasty</keyword>
  <keyword>elbow prosthesis</keyword>
  <keyword>delayed arthroplasty</keyword>
  <keyword>revision surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Elbow Fractures</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/NCT03302533
org study id: 001-2017
nct id: NCT03302533
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Total elbow arthroplasty (TEA) results in immediate pain release with good functional results
      after distal humerus fractures. But still open reduction and internal fixation is recommended
      as treatment of choise due to a lifelong loading limitiation, unknown implant survival and
      problematic revision surgery after TEA. The purpose of this study was to compare functional
      results and complication rates after primary total elbow arthroplasty (TEA) and TEA after
      failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal
      humerus fractures. We hypothesised that clinical and functional results are better for
      primary TEA with less complications.
Total elbow arthroplasty (TEA) results in immediate pain release with good functional results
      after distal humerus fractures. But still open reduction and internal fixation is recommended
      as treatment of choise due to a lifelong loading limitiation, unknown implant survival and
      problematic revision surgery after TEA. The purpose of this study was to compare functional
      results and complication rates after primary total elbow arthroplasty (TEA) and TEA after
      failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal
      humerus fractures.

      This retrospective study was performed at a level I trauma centre. All patients were informed
      about the study and provided written informed consent.

      All patients undergoing total elbow arthroplasty (TEA) were identified by electronically
      screening our database by the OPS codes 5-824.4 (implantation of a linked TEA) and 5-824.5
      (implantation of an unlinked TEA) between August 2008 and May 2014. Based on patient records
      and x-rays the indication for implantation of the TEA was retrospectively reviewed. All
      patients, who received a TEA for an acute trauma with fracture of the distal humerus (primary
      TEA) or due to a failed reconstruction or non-operative treatment after a distal humerus
      fracture (secondary TEA), were included in this study. A minimum follow-up of 6 months was
      set as inclusion criterion. Exclusion criteria were previous injury at the fractured elbow,
      neuro-muscular disease, cortisone or other immune suppressive therapy and open fracture grade
      II or higher according to Tscherne and Ostern.The patient records were reviewed for
      demographic and perioperative data. If the initial treatment was not conducted in our
      department, radiographs and patient records were requested. The follow-up examination
      included the evaluation of the range of motion and stability of the elbow, actual pain and
      satisfaction of the patient. To objectify the functional result the Mayo Elbow Performance
      Score (MEPS) and Disabilities of the Arm, Shoulder and Hand Score (DASH) were determined.
      Additionally, complications and revision surgeries were recorded. Complications were split up
      into minor (nerve irritation or postoperative haematoma) and major complications, which
      required a revision of the prosthesis. Periprosthetic fractures due to renewed fall with an
      adequate trauma were not counted as complication.

      Perioperative data, the functional result (range of motion, MEPS, DASH) and postoperative
      complications were described for each group. Subsequently, these results were statistically
      compared using the Mann-Whitney U test as a two-way analysis of variance for independent
      factors. A p-value ≤ 0.05 was considered statistically significant. The statistical analysis
      was performed using SPSS for MAC (IBM SPSS Statistics 22, Chicago, Illinois).

      We hypothesised that clinical and functional results are better for primary TEA with less
      complications.
observational model: Case-Control
time perspective: Retrospective
measure: Range of motion
time frame: minimum follow-up: 6 months
description: Measurement of the range of motion for extension/flexion
measure: Mayo Elbow Performance Score
time frame: minimum follow-up: 6 months
description: Objective score evaluation the function of the elbow
measure: Complication
time frame: minimum follow-up: 6 months
description: appearance of a complication
measure: DASH score
time frame: minimum follow-up: 6 months
description: Disabilities of the Arm, Shoulder and Hand: subjective score evaluation the function
arm group label: Primary arthroplasty
description: All patients who received TEA for an acute trauma with fracture of the distal humerus.
arm group label: Secondary arthroplasty
description: All patients who received TEA due to a failed reconstruction or non-operative treatment after a distal humerus fracture.
intervention type: Procedure
intervention name: Total elbow arthroplasty
description: Implantation of a total elbow arthroplasty after distal humerus fracture
arm group label: Primary arthroplasty
arm group label: Secondary arthroplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Diakoniekrankenhaus Friederikenstift
investigator full name: Dr. Alexander Ellwein
investigator title: Assistant Physician
mesh term: Fractures, Bone
mesh term: Elbow Fractures
sharing ipd: No