<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/NCT03272490</url>
  </required_header>
  <id_info>
    <org_study_id>12345</org_study_id>
    <nct_id>NCT03272490</nct_id>
  </id_info>
  <brief_title>Polyaxial Locking Plates in Treating Distal Humeral Fractures</brief_title>
  <official_title>Polyaxial Locking Plates in Treating Distal Humeral Fractures: a Comparative Randomized Trial for Clinical Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</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>
      20 patients with distal humeral fractures (AO 13-A1 - AO 13-C3) were included in the current&#xD;
      study since 2014. After completing the randomization plan, patients were distributed into two&#xD;
      groups for different variable angle locking plates (DePuy Synthes VA-LCP vs. Medartis Aptus&#xD;
      Elbow). Clinical and radiological follow-ups were conducted 6 weeks, 12 weeks, 6 months and&#xD;
      12 months after the operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before study initiation the approval of the local ethics committee of (Trial Number 253/14)&#xD;
      was obtained. The clinical trial included 20 patients with fractures of the distal humerus&#xD;
      recruited from a level-one university trauma centre. Patient recruitment was conducted&#xD;
      between 03/2014 and 12/2015. Fractures of the distal humerus, as defined by the AO&#xD;
      classification system (AO 13-A1 - AO 13-C3), were included in this study as they were&#xD;
      identified by the treating surgeon being applicable for locking plate treatment and after&#xD;
      written informed consent of the patients was obtained. All patients were randomized following&#xD;
      a randomization plan (Randlist, DatInf GmbH, Tübingen, Germany) for either being treated with&#xD;
      the DePuy Synthes VA-LCP 2.7/3.5 mm (DePuy Synthes, Umkirch, Germany) or with the Medartis&#xD;
      Aptus Elbow system 2.0/3.8 mm (Medartis, Basel, Switzerland). Both systems include&#xD;
      anatomically preshaped, polyaxial angular stable locking plates in various sizes. Angle&#xD;
      stable screw positioning with the freedom of +/- 15° off-axis screw placement gives the&#xD;
      surgeon a large variety in both systems.&#xD;
&#xD;
      The inclusion criteria involve all patients from the age of 18 to 95 years who suffered from&#xD;
      a distal humeral fracture (AO 13-A1 - AO 13-C3) that had to undergo operative treatment. The&#xD;
      exclusion criteria involve all under-aged patients (&lt; 18 years), pregnant patients and&#xD;
      patients with a mental disorder as well as patients under comprehensive legal support. In&#xD;
      addition, pathological fractures had been excluded from the study.&#xD;
&#xD;
      Surgical technique&#xD;
&#xD;
      All patients were operated by experienced upper extremity surgeons. The mean interval between&#xD;
      injury and operation was 2.4 days (range 0-12 days). General anaesthesia was used in all&#xD;
      cases and a single dose of 1.5 mg cephalosporin was given preoperatively for prophylaxis.&#xD;
      Patients were positioned in prone position with the injured arm on a radiolucent, small&#xD;
      padded arm holder. Under tourniquet control, the posterior approach (Bryan-Morrey) to the&#xD;
      distal humerus was performed in all cases. Additional olecranon osteotomy was performed in 7&#xD;
      cases (3x DePuy Synthes vs. 4x Medartis Aptus Elbow) presenting with AO type 13 C2 and AO&#xD;
      type 13 C3 fractures. Postoperatively, physiotherapy was initiated using the same&#xD;
      rehabilitation protocol for both groups. Passive and active assisted ROM was permitted&#xD;
      immediately without limitations, while weight bearing was restricted for 6 weeks.&#xD;
&#xD;
      Follow-up evaluation&#xD;
&#xD;
      All patients were initially followed-up 6 weeks after operation. Additional follow-ups were&#xD;
      performed 3, 6 and 12 months postoperatively. The follow-up examinations were carried out by&#xD;
      an independent investigator not involved in patient´s initial surgical treatment (MC). After&#xD;
      the assessment of pain using the visual analogue scale (VAS) was documented, ROM and&#xD;
      collateral ligament stability were documented on standardized scoring sheets. For subjective&#xD;
      evaluation, patients rated their satisfaction for elbow use on a scale of 1 to 6 (1-highly&#xD;
      satisfied; 2-satisfied; 3-moderate; 4-sufficient; 5-unsatisfied; 6-very unsatisfied).&#xD;
      Moreover, sensomotoric disturbances and postoperative complications were recorded. For&#xD;
      functional upper extremity and elbow scoring the shortened Disabilities of the Arm, Shoulder&#xD;
      and Hand Score (QuickDASH) and the Mayo Elbow Performance Score (MEPS) were comprised.&#xD;
      Postoperative x-rays were evaluated with special respect to bony healing, secondary loss of&#xD;
      reduction and heterotopic ossifications.&#xD;
&#xD;
      Statistics&#xD;
&#xD;
      Statistical analyses were performed using the statistical software SigmaStat (version 3.5;&#xD;
      Systat Software, San Jose, CA, USA). The scores at certain time points were compared with an&#xD;
      independent t test after a normality check had been passed and equal variances had been&#xD;
      detected. Normal distributed data with unequal variances would have been compared with&#xD;
      Welch's t test. Arbitrarily data was tested with Mann-Whitney U test. The significance level&#xD;
      was set at p= 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2014</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 6, 2017</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mayo Elbow Performance Score (MEPS)</measure>
    <time_frame>12 months</time_frame>
    <description>clinical and functional outcome</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Distal Humerus Fracture</condition>
  <arm_group>
    <arm_group_label>Medartis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgery using the Medartis Implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Synthes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgery using the Synthes implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Medartis</intervention_name>
    <description>Surgery using the medartis implant</description>
    <arm_group_label>Medartis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Synthes</intervention_name>
    <description>Surgery using the Synthes implant</description>
    <arm_group_label>Synthes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion criteria involve all patients from the age of 18 to 95 years who&#xD;
             suffered from a distal humeral fracture (AO 13-A1 - AO 13-C3) that had to undergo&#xD;
             operative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria involve all under-aged patients (&lt; 18 years), pregnant patients&#xD;
             and patients with a mental disorder as well as patients under comprehensive legal&#xD;
             support. In addition, pathological fractures had been excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Bibethaler, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Trauma Surgery Klinikum rechts der Isar Technical University of Munich, Germany Ismaninger Strasse 22 81675 Munich, Germany</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Dr. Chlodwig Kirchhoff</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>locking plate</keyword>
  <keyword>anatomical preshaped</keyword>
  <keyword>polyaxial</keyword>
  <keyword>outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Humeral Fractures</mesh_term>
    <mesh_term>Humeral Fractures, Distal</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/NCT03272490
org study id: 12345
nct id: NCT03272490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
20 patients with distal humeral fractures (AO 13-A1 - AO 13-C3) were included in the current
      study since 2014. After completing the randomization plan, patients were distributed into two
      groups for different variable angle locking plates (DePuy Synthes VA-LCP vs. Medartis Aptus
      Elbow). Clinical and radiological follow-ups were conducted 6 weeks, 12 weeks, 6 months and
      12 months after the operation.
Before study initiation the approval of the local ethics committee of (Trial Number 253/14)
      was obtained. The clinical trial included 20 patients with fractures of the distal humerus
      recruited from a level-one university trauma centre. Patient recruitment was conducted
      between 03/2014 and 12/2015. Fractures of the distal humerus, as defined by the AO
      classification system (AO 13-A1 - AO 13-C3), were included in this study as they were
      identified by the treating surgeon being applicable for locking plate treatment and after
      written informed consent of the patients was obtained. All patients were randomized following
      a randomization plan (Randlist, DatInf GmbH, Tübingen, Germany) for either being treated with
      the DePuy Synthes VA-LCP 2.7/3.5 mm (DePuy Synthes, Umkirch, Germany) or with the Medartis
      Aptus Elbow system 2.0/3.8 mm (Medartis, Basel, Switzerland). Both systems include
      anatomically preshaped, polyaxial angular stable locking plates in various sizes. Angle
      stable screw positioning with the freedom of +/- 15° off-axis screw placement gives the
      surgeon a large variety in both systems.

      The inclusion criteria involve all patients from the age of 18 to 95 years who suffered from
      a distal humeral fracture (AO 13-A1 - AO 13-C3) that had to undergo operative treatment. The
      exclusion criteria involve all under-aged patients (< 18 years), pregnant patients and
      patients with a mental disorder as well as patients under comprehensive legal support. In
      addition, pathological fractures had been excluded from the study.

      Surgical technique

      All patients were operated by experienced upper extremity surgeons. The mean interval between
      injury and operation was 2.4 days (range 0-12 days). General anaesthesia was used in all
      cases and a single dose of 1.5 mg cephalosporin was given preoperatively for prophylaxis.
      Patients were positioned in prone position with the injured arm on a radiolucent, small
      padded arm holder. Under tourniquet control, the posterior approach (Bryan-Morrey) to the
      distal humerus was performed in all cases. Additional olecranon osteotomy was performed in 7
      cases (3x DePuy Synthes vs. 4x Medartis Aptus Elbow) presenting with AO type 13 C2 and AO
      type 13 C3 fractures. Postoperatively, physiotherapy was initiated using the same
      rehabilitation protocol for both groups. Passive and active assisted ROM was permitted
      immediately without limitations, while weight bearing was restricted for 6 weeks.

      Follow-up evaluation

      All patients were initially followed-up 6 weeks after operation. Additional follow-ups were
      performed 3, 6 and 12 months postoperatively. The follow-up examinations were carried out by
      an independent investigator not involved in patient´s initial surgical treatment (MC). After
      the assessment of pain using the visual analogue scale (VAS) was documented, ROM and
      collateral ligament stability were documented on standardized scoring sheets. For subjective
      evaluation, patients rated their satisfaction for elbow use on a scale of 1 to 6 (1-highly
      satisfied; 2-satisfied; 3-moderate; 4-sufficient; 5-unsatisfied; 6-very unsatisfied).
      Moreover, sensomotoric disturbances and postoperative complications were recorded. For
      functional upper extremity and elbow scoring the shortened Disabilities of the Arm, Shoulder
      and Hand Score (QuickDASH) and the Mayo Elbow Performance Score (MEPS) were comprised.
      Postoperative x-rays were evaluated with special respect to bony healing, secondary loss of
      reduction and heterotopic ossifications.

      Statistics

      Statistical analyses were performed using the statistical software SigmaStat (version 3.5;
      Systat Software, San Jose, CA, USA). The scores at certain time points were compared with an
      independent t test after a normality check had been passed and equal variances had been
      detected. Normal distributed data with unequal variances would have been compared with
      Welch's t test. Arbitrarily data was tested with Mann-Whitney U test. The significance level
      was set at p= 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mayo Elbow Performance Score (MEPS)
time frame: 12 months
description: clinical and functional outcome
arm group label: Medartis
arm group type: Active Comparator
description: Surgery using the Medartis Implant
arm group label: Synthes
arm group type: Active Comparator
description: Surgery using the Synthes implant
intervention type: Procedure
intervention name: Medartis
description: Surgery using the medartis implant
arm group label: Medartis
intervention type: Procedure
intervention name: Synthes
description: Surgery using the Synthes implant
arm group label: Synthes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Peter Bibethaler, Prof.
role: Study Director
affiliation: Department of Trauma Surgery Klinikum rechts der Isar Technical University of Munich, Germany Ismaninger Strasse 22 81675 Munich, Germany
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Dr. Chlodwig Kirchhoff
investigator title: Principal Investigator
mesh term: Fractures, Bone
mesh term: Humeral Fractures
mesh term: Humeral Fractures, Distal
sharing ipd: No