<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/NCT03280602</url>
  </required_header>
  <id_info>
    <org_study_id>2017/671</org_study_id>
    <nct_id>NCT03280602</nct_id>
  </id_info>
  <brief_title>Operative Treatment of Olecranon Fractures</brief_title>
  <official_title>Randomzied Controlled Trial Comparing Tension Band Wiring and Plate Fixation in the Treatment of Olecranon Fractures in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</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>
      The incidence of olecranon fractures is 12 per 100.000. Traditionally, isolated olecranon&#xD;
      fractures have been treated with tension band wiring (TBW). There is a trend towards&#xD;
      increased use of plate fixation, though TBW has yielded good and comparable patient reported&#xD;
      outcomes. The latter method is substantially cost-effective, but higher complication reports&#xD;
      have been reported. There are only two randomized controlled trials comparing TBW and plate&#xD;
      fixation, and the literature is inconclusive in which fixation method is preferable in the&#xD;
      treatment of olecranon fractures. In this multi-center trial, adult patients (18-75 years)&#xD;
      with isolated olecranon fractures will be randomized to either TBW or plate fixation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      The incidence of proximal ulna fractures is 12 per 100.000, and 10 % of all fractures in the&#xD;
      upper extremity involve the olecranon. There are several systems classifying olecranon&#xD;
      fractures. One of the most frequently used is the Mayo classification system as described by&#xD;
      Cabanela and Morrey. Tension band wiring (TBW) is the most common operative technique for the&#xD;
      treatment of olecranon fractures, and is said to be the gold standard in the treatment of&#xD;
      non-comminuted and minimally comminuted displaced olecranon fractures. Treatment with TBW has&#xD;
      shown good clinical results, but due to the thin layer of tissue overlying the proximal ulna,&#xD;
      hardware issues are common. The frequency of hardware removal following TBW has been reported&#xD;
      as high as 82 %. Only two randomized trials have compared TBW and plate fixation of olecranon&#xD;
      fractures. Hume and Wiss compared TBW with one-third tubular plate fixation. The authors&#xD;
      found no significant functional differences between the treatment methods, but the rate of&#xD;
      symptomatic hardware problems was higher in the group treated with TBW. The authors also&#xD;
      noted that loss of reduction was higher in the TBW group at final follow-up (12 months after&#xD;
      surgery). Duckworth found no difference in patient reported outcome after one year. The&#xD;
      sophistication in plate fixation has evolved since Hume and Wiss published their 25 years&#xD;
      ago. The use of locking stable plate fixation in the treatment of olecranon fractures is&#xD;
      preferred by many surgeons, especially when treating osteoporotic individuals and in cases&#xD;
      with severe fracture fragmentation. Though locking stable implants have shown to improve&#xD;
      fragment fixation in biomechanical and cadaveric studies, better patient reported outcome in&#xD;
      clinical studies has yet to be proven. It is still unclear if all comminuted fractures should&#xD;
      be treated with plate fixation, or if moderately comminuted fractures can be treated with&#xD;
      TBW. Hardware related issues following plate fixation have also been described as a frequent&#xD;
      problem, and rates of hardware removal up to 56 % have been reported. When approaching the&#xD;
      issue of symptomatic hardware problems following TBW and plate fixation, one must take into&#xD;
      consideration that the magnitude of secondary surgery is different. The removal of the two&#xD;
      K-wires is less extensive than removing an angular stable plate fixation. Removal of&#xD;
      symptomatic pin protrusion can be achieved in local anesthesia at the outpatient clinic,&#xD;
      whereas plate removal routinely is done in the operating theatre, and usually requires that&#xD;
      patient is in regional or general anesthesia. Of course, if the wire cerclage has to be&#xD;
      removed in addition to the K-wires, the scope of the procedure is more comparable. There are&#xD;
      strong indications that locking plate fixation yield better results when treating severely&#xD;
      comminuted olecranon fractures, but the investigators do not know if these modern implants&#xD;
      are superior in the treatment of moderately comminuted fractures. Even so, there is a trend&#xD;
      toward treating all comminuted olecranon fractures with plate fixation, but the clinical&#xD;
      evidence supporting this is limited. The investigators believe there is a need for a robust&#xD;
      investigation in the treatment of olecranon fractures to identify the fracture patterns that&#xD;
      adequately can be treated with TBW and the ones that should be treated with locking plate&#xD;
      fixation.&#xD;
&#xD;
      Study aims:&#xD;
&#xD;
      The investigators want to compare an angular stable plate fixation with TBW in a randomized,&#xD;
      controlled multi-center trial. Our hypothesis is that TBW is non-inferior in the treatment of&#xD;
      Mayo type IIA and IIB fractures compared with an angular stable implant. The primary outcome&#xD;
      measure is the Quick Disability of the Arm, Shoulder and Hand outcome measure (QuickDASH) at&#xD;
      12 months&#xD;
&#xD;
      Study design and methodology:&#xD;
&#xD;
      The study is a randomized, controlled, multicenter trial. Adult patients (18-75 years)&#xD;
      admitted with a displaced olecranon fracture in need of surgery will be randomized to either&#xD;
      TBW or plate fixation. The design is semi-blinded. At follow-up, an independent investigator&#xD;
      will perform an interview and blinded functional examination, followed by an un-blinded&#xD;
      examination and interview. Patients will be recruited at the Oslo University Hospital, and&#xD;
      other hospitals in the region has been invited to participate in the trial. An experienced&#xD;
      trauma surgeon will verify that the fracture meets the inclusion criteria, and the patient&#xD;
      will be given thorough oral and written information. After signed consent, the randomization&#xD;
      allocation to treatment method will be performed by means of a web-solution made by NTNU&#xD;
      WebCRF system with the approval from the OUS Head of Patient Security. To secure an even&#xD;
      dispersion in regard to age of the patients and fracture pattern, the inclusion of study&#xD;
      patients will be stratified. This will achieve an equal randomization dispersion of patients&#xD;
      in in the age interval from 18 to 50 years, and 50 to 75 years. Comminuted and non-comminuted&#xD;
      fracture fractures will be randomized in the same fashion.&#xD;
&#xD;
      Power analysis and sample size:&#xD;
&#xD;
      Using the mean value of QuickDASH following olecranon fracture in a similar population, the&#xD;
      investigators found the standard deviation (SD) to equal 12 points. The minimal clinical&#xD;
      important difference (MCID) has been set to 8 points, and the non-inferiority limit is DASH&#xD;
      reduction of 10 points. Level of significance (α) equals 0.05. To prove non-inferiority, a&#xD;
      power of 0.90 and with non-inferiority limit at 10, the number required in each group is 39&#xD;
      patients. Taking into account a predicted loss of patients during follow-up, the&#xD;
      investigators aim to include at least 45 patients in each group.&#xD;
&#xD;
      Follow-up:&#xD;
&#xD;
      The study patients will be followed-up over a one year period (6 weeks, 12 weeks, 12 months).&#xD;
      The rate of hardware removal in both groups will be recorded, and the indication for removal&#xD;
      (pain, skin protrusion/wound problems, nerve irritation etc.) will be registered and&#xD;
      categorized. All other reoperations will be recorded as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</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 (Outcomes Assessor)</masking>
    <masking_description>Semi-blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The Quick Disability of the Arm, Shoulder and Hand Outcome Measure (QuickDASH)</measure>
    <time_frame>12 months</time_frame>
    <description>The QuickDASH questionnaire evaluates difficulty performing specific tasks and symptoms, social and work function, sleep and confidence. Scaling is ranked from 0 indicating least disability to 100 indicating most disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mayo Elbow Performance Score (MEPS)</measure>
    <time_frame>12 months</time_frame>
    <description>MEPS is the primary outcome parameter. MEPS consist of four categories evaluating pain, range of motion, stability and function.6 The scale ranges from 0 to 100, with higher score indicating better outcome. Pain is weighed highest of the 4 variables. Patient outcome can be categorized into excellent (MEPS &gt; 90), good (MEPS 75-90), fair (MEPS 60-74) and poor (MEPS &lt; 60).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>12 months</time_frame>
    <description>A hand dynamometer will be used to measure grip strength in both hands</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion (ROM)</measure>
    <time_frame>12 months</time_frame>
    <description>A goniometer will be used to register ROM in elbow flexion, extension and rotation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The EuroQol five dimensions questionnaire (EQ-5D-5L)</measure>
    <time_frame>12 months</time_frame>
    <description>Health status is measures health status/quality of life into one of five levels for the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The data is computed to a number (EQ-Index) ranging from 0-1.00, where 1.00 is the best possible outcome, and negative values describe a status theoretically worse than being dead. In addition, the patients score their overall life quality on a vertical line, directly measured in millimeters as EQ-VAS score (0-100, 100 best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with elbow function</measure>
    <time_frame>12 months</time_frame>
    <description>An individual satisfaction assessment will be recorded using a visual analogue scale (VAS) of elbow function at follow-up. Zero indicating minimal satisfaction, and 100 indicating maximal satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective pain on a scale from 0 (no pain) to 100.</measure>
    <time_frame>12 months</time_frame>
    <description>An individual pain assessment will be recorded using a visual analogue scale (VAS) of elbow pain at follow-up. Zero indicating no pain, and 100 indicating maximal pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>12 months</time_frame>
    <description>The patient charts will be reviewed for reports of neurological deficiencies, and an examination of neurologic function will be performed at follow-up. Scar problems, infections, non- and mal-unions and hardware issues will also be reviewed and reexamined. The definition of infection is:&#xD;
Less serious infection: Superficial wound infection with sign of skin inflammation and/or positive bacterial culture, without the need for secondary surgery, i.e. surgical debridement.&#xD;
Serious infection: Any postoperative wound infection or sign of deep infection that require secondary surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hardware removal</measure>
    <time_frame>12 months</time_frame>
    <description>Rates of planned and performed hardware removal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic evaluation</measure>
    <time_frame>12 months</time_frame>
    <description>Radiographs and computer tomographic (CT) scan will be obtained pre- and postoperatively for optimal classification. Radiographs will also be obtained at six weeks, 3 months, and 12 months. Plain x-rays will include true antero-posterior and lateral projections. The fracture pattern will be classified according to the Mayo classification and Schatzker classification. All radiographs will be reviewed and classified by two senior orthopedic trauma surgeons. Assessment of union and non-union will be assessed and recorded. Displacement of the fracture fragments is to be registered in millimeters at the level of the joint. The joint congruency following surgery and at the following radiographs will be evaluated. Osteoarthritis will be classified according to the system of Broberg and Morrey. Heterotopic ossification will be classified according to Hastings and Graham.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Olecranon Fracture</condition>
  <arm_group>
    <arm_group_label>Tension band wiring (TBW)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TBW following the AO principles with 2 x 1.6 mm K-wires and wire wire cerclage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plate fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Plate fixation with Syntes VA-LCP olecranon plates 2.7/3.5</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tension band wiring (TBW)</intervention_name>
    <description>2 x K-wire fixation (1.6 mm) and wire cerclage.</description>
    <arm_group_label>Plate fixation</arm_group_label>
    <arm_group_label>Tension band wiring (TBW)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Plate fixation</intervention_name>
    <description>Olecranon fractures in this arm are fixed with Synthes´ VA-LCP Olecranon Plates 2.7/3.5.</description>
    <arm_group_label>Plate fixation</arm_group_label>
    <arm_group_label>Tension band wiring (TBW)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the age of 18 and 75 years with an olecranon fracture Mayo type IIA&#xD;
             or IIB will be eligible for inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 or older than 75 years of age.&#xD;
&#xD;
          -  Unable to receive oral and written information.&#xD;
&#xD;
          -  Concomitant fracture in the injured extremity.&#xD;
&#xD;
          -  When the olecranon fracture extends distal to the coronoid process.&#xD;
&#xD;
          -  Previous injury or illness in the injured upper extremity with permanent reduced elbow&#xD;
             function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Duckworth AD, Clement ND, White TO, Court-Brown CM, McQueen MM. Plate Versus Tension-Band Wire Fixation for Olecranon Fractures: A Prospective Randomized Trial. J Bone Joint Surg Am. 2017 Aug 2;99(15):1261-1273. doi: 10.2106/JBJS.16.00773.</citation>
    <PMID>28763412</PMID>
  </reference>
  <reference>
    <citation>Hume MC, Wiss DA. Olecranon fractures. A clinical and radiographic comparison of tension band wiring and plate fixation. Clin Orthop Relat Res. 1992 Dec;(285):229-35.</citation>
    <PMID>1446443</PMID>
  </reference>
  <reference>
    <citation>Buijze G, Kloen P. Clinical evaluation of locking compression plate fixation for comminuted olecranon fractures. J Bone Joint Surg Am. 2009 Oct;91(10):2416-20. doi: 10.2106/JBJS.H.01419.</citation>
    <PMID>19797577</PMID>
  </reference>
  <reference>
    <citation>Chalidis BE, Sachinis NC, Samoladas EP, Dimitriou CG, Pournaras JD. Is tension band wiring technique the &quot;gold standard&quot; for the treatment of olecranon fractures? A long term functional outcome study. J Orthop Surg Res. 2008 Feb 22;3:9. doi: 10.1186/1749-799X-3-9.</citation>
    <PMID>18294381</PMID>
  </reference>
  <reference>
    <citation>Duckworth AD, Clement ND, Aitken SA, Court-Brown CM, McQueen MM. The epidemiology of fractures of the proximal ulna. Injury. 2012 Mar;43(3):343-6. doi: 10.1016/j.injury.2011.10.017. Epub 2011 Nov 9.</citation>
    <PMID>22077988</PMID>
  </reference>
  <reference>
    <citation>Baecher N, Edwards S. Olecranon fractures. J Hand Surg Am. 2013 Mar;38(3):593-604. doi: 10.1016/j.jhsa.2012.12.036.</citation>
    <PMID>23428192</PMID>
  </reference>
  <reference>
    <citation>Edwards SG, Martin BD, Fu RH, Gill JM, Nezhad MK, Orr JA, Ferrucci AM, Love JM, Booth R, Singer A, Hsieh AH. Comparison of olecranon plate fixation in osteoporotic bone: do current technologies and designs make a difference? J Orthop Trauma. 2011 May;25(5):306-11. doi: 10.1097/BOT.0b013e3181f22465.</citation>
    <PMID>21464739</PMID>
  </reference>
  <reference>
    <citation>Karlsson MK, Hasserius R, Karlsson C, Besjakov J, Josefsson PO. Fractures of the olecranon: a 15- to 25-year followup of 73 patients. Clin Orthop Relat Res. 2002 Oct;(403):205-12.</citation>
    <PMID>12360028</PMID>
  </reference>
  <reference>
    <citation>Matar HE, Ali AA, Buckley S, Garlick NI, Atkinson HD. Surgical interventions for treating fractures of the olecranon in adults. Cochrane Database Syst Rev. 2014 Nov 26;2014(11):CD010144. doi: 10.1002/14651858.CD010144.pub2.</citation>
    <PMID>25426876</PMID>
  </reference>
  <reference>
    <citation>Rommens PM, Kuchle R, Schneider RU, Reuter M. Olecranon fractures in adults: factors influencing outcome. Injury. 2004 Nov;35(11):1149-57. doi: 10.1016/j.injury.2003.12.002.</citation>
    <PMID>15488508</PMID>
  </reference>
  <reference>
    <citation>Snoddy MC, Lang MF, An TJ, Mitchell PM, Grantham WJ, Hooe BS, Kay HF, Bhatia R, Thakore RV, Evans JM, Obremskey WT, Sethi MK. Olecranon fractures: factors influencing re-operation. Int Orthop. 2014 Aug;38(8):1711-6. doi: 10.1007/s00264-014-2378-y. Epub 2014 Jun 4.</citation>
    <PMID>24893946</PMID>
  </reference>
  <reference>
    <citation>Tarallo L, Mugnai R, Adani R, Capra F, Zambianchi F, Catani F. Simple and comminuted displaced olecranon fractures: a clinical comparison between tension band wiring and plate fixation techniques. Arch Orthop Trauma Surg. 2014 Aug;134(8):1107-14. doi: 10.1007/s00402-014-2021-9. Epub 2014 Jun 17.</citation>
    <PMID>24935660</PMID>
  </reference>
  <reference>
    <citation>Wagner FC, Konstantinidis L, Hohloch N, Hohloch L, Suedkamp NP, Reising K. Biomechanical evaluation of two innovative locking implants for comminuted olecranon fractures under high-cycle loading conditions. Injury. 2015;46(6):985-9. doi: 10.1016/j.injury.2015.02.010. Epub 2015 Feb 18.</citation>
    <PMID>25771445</PMID>
  </reference>
  <reference>
    <citation>Gruszka D, Arand C, Nowak T, Dietz SO, Wagner D, Rommens P. Olecranon tension plating or olecranon tension band wiring? A comparative biomechanical study. Int Orthop. 2015 May;39(5):955-60. doi: 10.1007/s00264-015-2703-0. Epub 2015 Feb 25.</citation>
    <PMID>25711396</PMID>
  </reference>
  <reference>
    <citation>Wilson J, Bajwa A, Kamath V, Rangan A. Biomechanical comparison of interfragmentary compression in transverse fractures of the olecranon. J Bone Joint Surg Br. 2011 Feb;93(2):245-50. doi: 10.1302/0301-620X.93B2.24613.</citation>
    <PMID>21282766</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Kaare Sourin Midtgaard</investigator_full_name>
    <investigator_title>Consultant orthopedic surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Olecranon Fracture</mesh_term>
    <mesh_term>Ulna Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03280602
org study id: 2017/671
nct id: NCT03280602
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The incidence of olecranon fractures is 12 per 100.000. Traditionally, isolated olecranon
      fractures have been treated with tension band wiring (TBW). There is a trend towards
      increased use of plate fixation, though TBW has yielded good and comparable patient reported
      outcomes. The latter method is substantially cost-effective, but higher complication reports
      have been reported. There are only two randomized controlled trials comparing TBW and plate
      fixation, and the literature is inconclusive in which fixation method is preferable in the
      treatment of olecranon fractures. In this multi-center trial, adult patients (18-75 years)
      with isolated olecranon fractures will be randomized to either TBW or plate fixation.
Introduction:

      The incidence of proximal ulna fractures is 12 per 100.000, and 10 % of all fractures in the
      upper extremity involve the olecranon. There are several systems classifying olecranon
      fractures. One of the most frequently used is the Mayo classification system as described by
      Cabanela and Morrey. Tension band wiring (TBW) is the most common operative technique for the
      treatment of olecranon fractures, and is said to be the gold standard in the treatment of
      non-comminuted and minimally comminuted displaced olecranon fractures. Treatment with TBW has
      shown good clinical results, but due to the thin layer of tissue overlying the proximal ulna,
      hardware issues are common. The frequency of hardware removal following TBW has been reported
      as high as 82 %. Only two randomized trials have compared TBW and plate fixation of olecranon
      fractures. Hume and Wiss compared TBW with one-third tubular plate fixation. The authors
      found no significant functional differences between the treatment methods, but the rate of
      symptomatic hardware problems was higher in the group treated with TBW. The authors also
      noted that loss of reduction was higher in the TBW group at final follow-up (12 months after
      surgery). Duckworth found no difference in patient reported outcome after one year. The
      sophistication in plate fixation has evolved since Hume and Wiss published their 25 years
      ago. The use of locking stable plate fixation in the treatment of olecranon fractures is
      preferred by many surgeons, especially when treating osteoporotic individuals and in cases
      with severe fracture fragmentation. Though locking stable implants have shown to improve
      fragment fixation in biomechanical and cadaveric studies, better patient reported outcome in
      clinical studies has yet to be proven. It is still unclear if all comminuted fractures should
      be treated with plate fixation, or if moderately comminuted fractures can be treated with
      TBW. Hardware related issues following plate fixation have also been described as a frequent
      problem, and rates of hardware removal up to 56 % have been reported. When approaching the
      issue of symptomatic hardware problems following TBW and plate fixation, one must take into
      consideration that the magnitude of secondary surgery is different. The removal of the two
      K-wires is less extensive than removing an angular stable plate fixation. Removal of
      symptomatic pin protrusion can be achieved in local anesthesia at the outpatient clinic,
      whereas plate removal routinely is done in the operating theatre, and usually requires that
      patient is in regional or general anesthesia. Of course, if the wire cerclage has to be
      removed in addition to the K-wires, the scope of the procedure is more comparable. There are
      strong indications that locking plate fixation yield better results when treating severely
      comminuted olecranon fractures, but the investigators do not know if these modern implants
      are superior in the treatment of moderately comminuted fractures. Even so, there is a trend
      toward treating all comminuted olecranon fractures with plate fixation, but the clinical
      evidence supporting this is limited. The investigators believe there is a need for a robust
      investigation in the treatment of olecranon fractures to identify the fracture patterns that
      adequately can be treated with TBW and the ones that should be treated with locking plate
      fixation.

      Study aims:

      The investigators want to compare an angular stable plate fixation with TBW in a randomized,
      controlled multi-center trial. Our hypothesis is that TBW is non-inferior in the treatment of
      Mayo type IIA and IIB fractures compared with an angular stable implant. The primary outcome
      measure is the Quick Disability of the Arm, Shoulder and Hand outcome measure (QuickDASH) at
      12 months

      Study design and methodology:

      The study is a randomized, controlled, multicenter trial. Adult patients (18-75 years)
      admitted with a displaced olecranon fracture in need of surgery will be randomized to either
      TBW or plate fixation. The design is semi-blinded. At follow-up, an independent investigator
      will perform an interview and blinded functional examination, followed by an un-blinded
      examination and interview. Patients will be recruited at the Oslo University Hospital, and
      other hospitals in the region has been invited to participate in the trial. An experienced
      trauma surgeon will verify that the fracture meets the inclusion criteria, and the patient
      will be given thorough oral and written information. After signed consent, the randomization
      allocation to treatment method will be performed by means of a web-solution made by NTNU
      WebCRF system with the approval from the OUS Head of Patient Security. To secure an even
      dispersion in regard to age of the patients and fracture pattern, the inclusion of study
      patients will be stratified. This will achieve an equal randomization dispersion of patients
      in in the age interval from 18 to 50 years, and 50 to 75 years. Comminuted and non-comminuted
      fracture fractures will be randomized in the same fashion.

      Power analysis and sample size:

      Using the mean value of QuickDASH following olecranon fracture in a similar population, the
      investigators found the standard deviation (SD) to equal 12 points. The minimal clinical
      important difference (MCID) has been set to 8 points, and the non-inferiority limit is DASH
      reduction of 10 points. Level of significance (α) equals 0.05. To prove non-inferiority, a
      power of 0.90 and with non-inferiority limit at 10, the number required in each group is 39
      patients. Taking into account a predicted loss of patients during follow-up, the
      investigators aim to include at least 45 patients in each group.

      Follow-up:

      The study patients will be followed-up over a one year period (6 weeks, 12 weeks, 12 months).
      The rate of hardware removal in both groups will be recorded, and the indication for removal
      (pain, skin protrusion/wound problems, nerve irritation etc.) will be registered and
      categorized. All other reoperations will be recorded as well.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Semi-blinded
measure: The Quick Disability of the Arm, Shoulder and Hand Outcome Measure (QuickDASH)
time frame: 12 months
description: The QuickDASH questionnaire evaluates difficulty performing specific tasks and symptoms, social and work function, sleep and confidence. Scaling is ranked from 0 indicating least disability to 100 indicating most disability.
measure: Mayo Elbow Performance Score (MEPS)
time frame: 12 months
description: MEPS is the primary outcome parameter. MEPS consist of four categories evaluating pain, range of motion, stability and function.6 The scale ranges from 0 to 100, with higher score indicating better outcome. Pain is weighed highest of the 4 variables. Patient outcome can be categorized into excellent (MEPS > 90), good (MEPS 75-90), fair (MEPS 60-74) and poor (MEPS < 60).
measure: Grip strength
time frame: 12 months
description: A hand dynamometer will be used to measure grip strength in both hands
measure: Range of motion (ROM)
time frame: 12 months
description: A goniometer will be used to register ROM in elbow flexion, extension and rotation.
measure: The EuroQol five dimensions questionnaire (EQ-5D-5L)
time frame: 12 months
description: Health status is measures health status/quality of life into one of five levels for the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The data is computed to a number (EQ-Index) ranging from 0-1.00, where 1.00 is the best possible outcome, and negative values describe a status theoretically worse than being dead. In addition, the patients score their overall life quality on a vertical line, directly measured in millimeters as EQ-VAS score (0-100, 100 best).
measure: Satisfaction with elbow function
time frame: 12 months
description: An individual satisfaction assessment will be recorded using a visual analogue scale (VAS) of elbow function at follow-up. Zero indicating minimal satisfaction, and 100 indicating maximal satisfaction.
measure: Subjective pain on a scale from 0 (no pain) to 100.
time frame: 12 months
description: An individual pain assessment will be recorded using a visual analogue scale (VAS) of elbow pain at follow-up. Zero indicating no pain, and 100 indicating maximal pain.
measure: Complications
time frame: 12 months
description: The patient charts will be reviewed for reports of neurological deficiencies, and an examination of neurologic function will be performed at follow-up. Scar problems, infections, non- and mal-unions and hardware issues will also be reviewed and reexamined. The definition of infection is:
Less serious infection: Superficial wound infection with sign of skin inflammation and/or positive bacterial culture, without the need for secondary surgery, i.e. surgical debridement.
Serious infection: Any postoperative wound infection or sign of deep infection that require secondary surgery.
measure: Hardware removal
time frame: 12 months
description: Rates of planned and performed hardware removal.
measure: Radiographic evaluation
time frame: 12 months
description: Radiographs and computer tomographic (CT) scan will be obtained pre- and postoperatively for optimal classification. Radiographs will also be obtained at six weeks, 3 months, and 12 months. Plain x-rays will include true antero-posterior and lateral projections. The fracture pattern will be classified according to the Mayo classification and Schatzker classification. All radiographs will be reviewed and classified by two senior orthopedic trauma surgeons. Assessment of union and non-union will be assessed and recorded. Displacement of the fracture fragments is to be registered in millimeters at the level of the joint. The joint congruency following surgery and at the following radiographs will be evaluated. Osteoarthritis will be classified according to the system of Broberg and Morrey. Heterotopic ossification will be classified according to Hastings and Graham.
arm group label: Tension band wiring (TBW)
arm group type: Active Comparator
description: TBW following the AO principles with 2 x 1.6 mm K-wires and wire wire cerclage.
arm group label: Plate fixation
arm group type: Active Comparator
description: Plate fixation with Syntes VA-LCP olecranon plates 2.7/3.5
intervention type: Procedure
intervention name: Tension band wiring (TBW)
description: 2 x K-wire fixation (1.6 mm) and wire cerclage.
arm group label: Plate fixation
arm group label: Tension band wiring (TBW)
intervention type: Procedure
intervention name: Plate fixation
description: Olecranon fractures in this arm are fixed with Synthes´ VA-LCP Olecranon Plates 2.7/3.5.
arm group label: Plate fixation
arm group label: Tension band wiring (TBW)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Norway
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PMID: 28763412
citation: Hume MC, Wiss DA. Olecranon fractures. A clinical and radiographic comparison of tension band wiring and plate fixation. Clin Orthop Relat Res. 1992 Dec;(285):229-35.
PMID: 1446443
citation: Buijze G, Kloen P. Clinical evaluation of locking compression plate fixation for comminuted olecranon fractures. J Bone Joint Surg Am. 2009 Oct;91(10):2416-20. doi: 10.2106/JBJS.H.01419.
PMID: 19797577
citation: Chalidis BE, Sachinis NC, Samoladas EP, Dimitriou CG, Pournaras JD. Is tension band wiring technique the "gold standard" for the treatment of olecranon fractures? A long term functional outcome study. J Orthop Surg Res. 2008 Feb 22;3:9. doi: 10.1186/1749-799X-3-9.
PMID: 18294381
citation: Duckworth AD, Clement ND, Aitken SA, Court-Brown CM, McQueen MM. The epidemiology of fractures of the proximal ulna. Injury. 2012 Mar;43(3):343-6. doi: 10.1016/j.injury.2011.10.017. Epub 2011 Nov 9.
PMID: 22077988
citation: Baecher N, Edwards S. Olecranon fractures. J Hand Surg Am. 2013 Mar;38(3):593-604. doi: 10.1016/j.jhsa.2012.12.036.
PMID: 23428192
citation: Edwards SG, Martin BD, Fu RH, Gill JM, Nezhad MK, Orr JA, Ferrucci AM, Love JM, Booth R, Singer A, Hsieh AH. Comparison of olecranon plate fixation in osteoporotic bone: do current technologies and designs make a difference? J Orthop Trauma. 2011 May;25(5):306-11. doi: 10.1097/BOT.0b013e3181f22465.
PMID: 21464739
citation: Karlsson MK, Hasserius R, Karlsson C, Besjakov J, Josefsson PO. Fractures of the olecranon: a 15- to 25-year followup of 73 patients. Clin Orthop Relat Res. 2002 Oct;(403):205-12.
PMID: 12360028
citation: Matar HE, Ali AA, Buckley S, Garlick NI, Atkinson HD. Surgical interventions for treating fractures of the olecranon in adults. Cochrane Database Syst Rev. 2014 Nov 26;2014(11):CD010144. doi: 10.1002/14651858.CD010144.pub2.
PMID: 25426876
citation: Rommens PM, Kuchle R, Schneider RU, Reuter M. Olecranon fractures in adults: factors influencing outcome. Injury. 2004 Nov;35(11):1149-57. doi: 10.1016/j.injury.2003.12.002.
PMID: 15488508
citation: Snoddy MC, Lang MF, An TJ, Mitchell PM, Grantham WJ, Hooe BS, Kay HF, Bhatia R, Thakore RV, Evans JM, Obremskey WT, Sethi MK. Olecranon fractures: factors influencing re-operation. Int Orthop. 2014 Aug;38(8):1711-6. doi: 10.1007/s00264-014-2378-y. Epub 2014 Jun 4.
PMID: 24893946
citation: Tarallo L, Mugnai R, Adani R, Capra F, Zambianchi F, Catani F. Simple and comminuted displaced olecranon fractures: a clinical comparison between tension band wiring and plate fixation techniques. Arch Orthop Trauma Surg. 2014 Aug;134(8):1107-14. doi: 10.1007/s00402-014-2021-9. Epub 2014 Jun 17.
PMID: 24935660
citation: Wagner FC, Konstantinidis L, Hohloch N, Hohloch L, Suedkamp NP, Reising K. Biomechanical evaluation of two innovative locking implants for comminuted olecranon fractures under high-cycle loading conditions. Injury. 2015;46(6):985-9. doi: 10.1016/j.injury.2015.02.010. Epub 2015 Feb 18.
PMID: 25771445
citation: Gruszka D, Arand C, Nowak T, Dietz SO, Wagner D, Rommens P. Olecranon tension plating or olecranon tension band wiring? A comparative biomechanical study. Int Orthop. 2015 May;39(5):955-60. doi: 10.1007/s00264-015-2703-0. Epub 2015 Feb 25.
PMID: 25711396
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PMID: 21282766
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Kaare Sourin Midtgaard
investigator title: Consultant orthopedic surgeon
mesh term: Fractures, Bone
mesh term: Olecranon Fracture
mesh term: Ulna Fractures
sharing ipd: Undecided