<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/NCT03773848</url>
  </required_header>
  <id_info>
    <org_study_id>Hook plate vs Tightrope</org_study_id>
    <nct_id>NCT03773848</nct_id>
  </id_info>
  <brief_title>Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle</brief_title>
  <official_title>Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      to compare the clinical &amp; radiological outcomes of hook plate &amp; tightrope fixation in&#xD;
      fracture of lateral third clavicle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult clavicle fractures account for 4% to 10% of fractures. Distal clavicle fractures occurs&#xD;
      in 25% to 30% of all clavicle fracture.The management of fractures of the distal clavicle has&#xD;
      been a matter of debate in literature. Neer in 1968 suggested a new classification and&#xD;
      proposed general treatment guidelines . Type I and type III fractures are generally treated&#xD;
      non-operatively. For type II fractures, surgical management is the treatment of choice .There&#xD;
      are numerous operative techniques reported in the past. The methods of surgical treatment&#xD;
      could be summarised as follows:&#xD;
&#xD;
        1. Fixation in terms of K-wires and different pins such as the Steinmann pin, and Knowles&#xD;
           pin. This fixation could also be augmented with concomitant tension band wires&#xD;
&#xD;
        2. Coracoclavicular indirect fixation with the use of screws, suture anchors, Dacron graft&#xD;
           or Mersilene tape&#xD;
&#xD;
        3. Open reduction and clavicular plate fixation with the use of different plate systems&#xD;
           such as the Balser plate,locked plate,hook plate, etc.&#xD;
&#xD;
      Different surgical techniques have their own advantages and disadvantages With more than 20&#xD;
      techniques described so far, no single fixation is ideal and perfect. There is still no&#xD;
      consensus regarding the best surgical method to fix these fracture ,the investigators choose&#xD;
      two of the most common of these methods and evaluate &amp; compare best radiological &amp; clinical&#xD;
      outcomes of both.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months</measure>
    <time_frame>at 6 weeks &amp; 6 months post-operatively.</time_frame>
    <description>The DASH is a self-administered questionnaire that consists of thirty core questions and an optional additional eight questions assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, with lower scores correlating to minimal impairment and higher scores indicating more impairment. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating more disability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fracture Healing</measure>
    <time_frame>at 6 weeks &amp; 6 months post-operatively.</time_frame>
    <description>Radiological evaluation of the fracture by using antero-posterior and axillary views x-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>Intra-operatively</time_frame>
    <description>Recording of the blood loss amount during surgery in milliliters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation time</measure>
    <time_frame>Intra-operatively</time_frame>
    <description>Calculation of the exposure time to radiations during surgery in minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin condition</measure>
    <time_frame>at 6 weeks</time_frame>
    <description>Evaluation of skin condition of the surgical incision by clinical inspection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Fracture Clavicle</condition>
  <arm_group>
    <arm_group_label>A- hook plate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with hook plate. X-ray was applied to check the grade of reduction before the operation is completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B- tightrope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with tightrope. X-ray was applied to check the grade of reduction before the operation is completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Reduction Internal Fixation (ORIF)</intervention_name>
    <description>Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate &amp; tightrope</description>
    <arm_group_label>A- hook plate</arm_group_label>
    <arm_group_label>B- tightrope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (over 16 years old) including both sexes.&#xD;
&#xD;
          -  Acute fractures within 3 weeks of injury.&#xD;
&#xD;
          -  Isolated &amp; closed fractures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pathological fracture of distal clavicle.&#xD;
&#xD;
          -  Deteriorated general health.&#xD;
&#xD;
          -  Previous history of dysfunction with the affected shoulder.&#xD;
&#xD;
          -  Incomplete medical records or lost to follow up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>David</last_name>
    <phone>+201221748069</phone>
    <email>davidmounir1@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Flinkkila T, Heikkila A, Sirnio K, Pakarinen H. TightRope versus clavicular hook plate fixation for unstable distal clavicular fractures. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):465-9. doi: 10.1007/s00590-014-1526-9. Epub 2014 Sep 9.</citation>
    <PMID>25200315</PMID>
  </reference>
  <reference>
    <citation>Haque S, Khan A, Sharma A, Sundararajan S. Technical tip: tightrope fixation of neer type II distal clavicle fracture supported by a case series. Pol Orthop Traumatol. 2014 Mar 27;79:19-22.</citation>
    <PMID>24675020</PMID>
  </reference>
  <reference>
    <citation>Lee W, Choi CH, Choi YR, Lim KH, Chun YM. Clavicle hook plate fixation for distal-third clavicle fracture (Neer type II): comparison of clinical and radiologic outcomes between Neer types IIA and IIB. J Shoulder Elbow Surg. 2017 Jul;26(7):1210-1215. doi: 10.1016/j.jse.2016.11.046. Epub 2017 Jan 26.</citation>
    <PMID>28131682</PMID>
  </reference>
  <reference>
    <citation>Yan HW, Li L, Wang RC, Yang Y, Xie Y, Tang J, Shi ZY. Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture. Orthop Traumatol Surg Res. 2017 Dec;103(8):1287-1293. doi: 10.1016/j.otsr.2017.07.006. Epub 2017 Aug 8.</citation>
    <PMID>28801112</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>David Mounir Kamal Ibrahim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</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/NCT03773848
org study id: Hook plate vs Tightrope
nct id: NCT03773848
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
to compare the clinical & radiological outcomes of hook plate & tightrope fixation in
      fracture of lateral third clavicle.
Adult clavicle fractures account for 4% to 10% of fractures. Distal clavicle fractures occurs
      in 25% to 30% of all clavicle fracture.The management of fractures of the distal clavicle has
      been a matter of debate in literature. Neer in 1968 suggested a new classification and
      proposed general treatment guidelines . Type I and type III fractures are generally treated
      non-operatively. For type II fractures, surgical management is the treatment of choice .There
      are numerous operative techniques reported in the past. The methods of surgical treatment
      could be summarised as follows:

        1. Fixation in terms of K-wires and different pins such as the Steinmann pin, and Knowles
           pin. This fixation could also be augmented with concomitant tension band wires

        2. Coracoclavicular indirect fixation with the use of screws, suture anchors, Dacron graft
           or Mersilene tape

        3. Open reduction and clavicular plate fixation with the use of different plate systems
           such as the Balser plate,locked plate,hook plate, etc.

      Different surgical techniques have their own advantages and disadvantages With more than 20
      techniques described so far, no single fixation is ideal and perfect. There is still no
      consensus regarding the best surgical method to fix these fracture ,the investigators choose
      two of the most common of these methods and evaluate & compare best radiological & clinical
      outcomes of both.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months
time frame: at 6 weeks & 6 months post-operatively.
description: The DASH is a self-administered questionnaire that consists of thirty core questions and an optional additional eight questions assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, with lower scores correlating to minimal impairment and higher scores indicating more impairment. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating more disability
measure: Fracture Healing
time frame: at 6 weeks & 6 months post-operatively.
description: Radiological evaluation of the fracture by using antero-posterior and axillary views x-ray
measure: Blood loss
time frame: Intra-operatively
description: Recording of the blood loss amount during surgery in milliliters.
measure: Radiation time
time frame: Intra-operatively
description: Calculation of the exposure time to radiations during surgery in minutes.
measure: Skin condition
time frame: at 6 weeks
description: Evaluation of skin condition of the surgical incision by clinical inspection
arm group label: A- hook plate
arm group type: Experimental
description: All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with hook plate. X-ray was applied to check the grade of reduction before the operation is completed.
arm group label: B- tightrope
arm group type: Experimental
description: All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with tightrope. X-ray was applied to check the grade of reduction before the operation is completed.
intervention type: Procedure
intervention name: Open Reduction Internal Fixation (ORIF)
description: Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate & tightrope
arm group label: A- hook plate
arm group label: B- tightrope
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: David
phone: +201221748069
email: davidmounir1@gmail.com
citation: Flinkkila T, Heikkila A, Sirnio K, Pakarinen H. TightRope versus clavicular hook plate fixation for unstable distal clavicular fractures. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):465-9. doi: 10.1007/s00590-014-1526-9. Epub 2014 Sep 9.
PMID: 25200315
citation: Haque S, Khan A, Sharma A, Sundararajan S. Technical tip: tightrope fixation of neer type II distal clavicle fracture supported by a case series. Pol Orthop Traumatol. 2014 Mar 27;79:19-22.
PMID: 24675020
citation: Lee W, Choi CH, Choi YR, Lim KH, Chun YM. Clavicle hook plate fixation for distal-third clavicle fracture (Neer type II): comparison of clinical and radiologic outcomes between Neer types IIA and IIB. J Shoulder Elbow Surg. 2017 Jul;26(7):1210-1215. doi: 10.1016/j.jse.2016.11.046. Epub 2017 Jan 26.
PMID: 28131682
citation: Yan HW, Li L, Wang RC, Yang Y, Xie Y, Tang J, Shi ZY. Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture. Orthop Traumatol Surg Res. 2017 Dec;103(8):1287-1293. doi: 10.1016/j.otsr.2017.07.006. Epub 2017 Aug 8.
PMID: 28801112
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: David Mounir Kamal Ibrahim
investigator title: Principal Investigator
mesh term: Fractures, Bone