xml: <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/NCT06019260</url>
    </required_header>
    <id_info>
      <org_study_id>Acute AC Joint disruption</org_study_id>
      <nct_id>NCT06019260</nct_id>
    </id_info>
    <brief_title>Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device</brief_title>
    <official_title>Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Compare the clinical and radiological outcome between the arthroscopic and open surgical&#xD;
        repair using suture button device method in cases with acute AC joint disruption&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acromioclavicular (AC) joint dislocation is a common shoulder injury, especially among&#xD;
        athletes and has an estimated incidence of 17% of all shoulder injuries and30%-50% of&#xD;
        athletic shoulder injuries ,In most cases, these are caused by a direct fall on the&#xD;
        ipsilateral shoulder tip. The indirect mechanism of injury with an extended arm is rare, The&#xD;
        Rockwood classification system is currently used and based on the degree and direction of the&#xD;
        disrupted anatomy of the AC joint.&#xD;
  &#xD;
        Despite the high prevalence of this injury, there is no consensus about its optimal&#xD;
        treatment. A variety of surgical procedures are described in the literature, such as an&#xD;
        augmented suture with absorbable materials, stabilization with Kirschner (K)-wires in&#xD;
        combination with or without additional wire loops, hook plates, or the Bosworth screw, but&#xD;
        none can be considered the gold standard of operative AC joint stabilization, another&#xD;
        treatment option was offered by the Tight Rope system, This technique was developed as a&#xD;
        minimally invasive procedure in the management of AC dislocations. Because of its minimally&#xD;
        invasive approach, it reduces soft tissue damage and yields better cosmetic results.9 Also,&#xD;
        there is no need for reoperation to remove the hardware that might screws, or plates.&#xD;
        Moreover, the complications of hardware failure, like breakage, dislocations, or bone&#xD;
        fractures, are minimized&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Radiological evaluation using the true anteroposterior view of the shoulder</measure>
      <time_frame>preoperative, three month postoperative and six month postoperative</time_frame>
      <description>Radiological evaluation using the true anteroposterior view of the shoulder and AC projection (10 cephalic tilt with the beam centered over the AC joint)</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Acromioclavicular Joint Dislocation</condition>
    <arm_group>
      <arm_group_label>group 1</arm_group_label>
      <description>open surgical repair using suture button device method in acute acromioclavicular joint disruption</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group 2</arm_group_label>
      <description>arthroscopic assisted treatment of acute acromioclavicular joint disruption using suture button device</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients meeting the inclusion criteria and willing to take part in the study will be&#xD;
          included investigators conducted an a priori test for sample size calculation using the&#xD;
          G*Power 3.1.9.2 software. investigators assumed a CMS mean difference between the 2 groups&#xD;
          of 16 points, a standard deviation of 20 points, an alpha of 0.05, and power (1 - b) of&#xD;
          80%; 21 subjects had to be included in each group. Our goal was to include 27 cases in each&#xD;
          group to compensate for any lost subjects during the follow-up phase&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age of 16 to 60 years&#xD;
  &#xD;
            -  Definite radiographic diagnosis of isolated Rockwood type IIIb(unstable), IV and type&#xD;
               v acromioclavicular joint dislocation&#xD;
  &#xD;
            -  Time from injury to operation &lt; 3 weeks&#xD;
  &#xD;
            -  Patient with complete at least 12-month follow-up assessments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  . Age outside the range&#xD;
  &#xD;
                 -  Open injury, old injury (≥ 3 weeks since injury)&#xD;
  &#xD;
                 -  Injury caused by other diseases (tendinitis, metabolic, et al.), concurrent&#xD;
                    shoulder osteoarthritis, arthropathy or any fracture&#xD;
  &#xD;
                 -  Any previous operation of the injured limb&#xD;
  &#xD;
                 -  Incomplete data or follow-up &lt; 12 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohamed Adel abdelmajeed, residant</last_name>
      <phone>01121650557</phone>
      <email>mohamedadel@med.aun.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hatem Galal Zaki, Prof.Dr</last_name>
      <phone>01221762266</phone>
      <email>Said.hgz@aun.edu.eg</email>
    </overall_contact_backup>
    <reference>
      <citation>Jeong JY, Chun YM. Treatment of acute high-grade acromioclavicular joint dislocation. Clin Shoulder Elb. 2020 Sep 1;23(3):159-165. doi: 10.5397/cise.2020.00150. eCollection 2020 Sep.</citation>
      <PMID>33330252</PMID>
    </reference>
    <reference>
      <citation>Vijayan S, Kulkarni MS, Jain CP, Shetty S, Aroor MN, Rao SK. Bifocal Stabilisation of Acute Acromioclavicular Joint Dislocation using Suture Anchor and Temporary K-Wires: A Retrospective Analysis. Malays Orthop J. 2022 Nov;16(3):104-112. doi: 10.5704/MOJ.2211.016.</citation>
      <PMID>36589364</PMID>
    </reference>
    <reference>
      <citation>Bezruchenko S, Dolhopolov O, Yarova M, Luchko R, Mazevych V. Clinical Evaluation and Instrumental Diagnostics in Acute Acromioclavicular Joint Dislocation. Ortop Traumatol Rehabil. 2022 Feb 28;24(1):1-12. doi: 10.5604/01.3001.0015.7800.</citation>
      <PMID>35297375</PMID>
    </reference>
    <reference>
      <citation>Liu X, Huangfu X, Zhao J. Arthroscopic treatment of acute acromioclavicular joint dislocation by coracoclavicular ligament augmentation. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1460-6. doi: 10.1007/s00167-013-2800-9. Epub 2013 Dec 10.</citation>
      <PMID>24318508</PMID>
    </reference>
    <reference>
      <citation>Lu D, Wang T, Hong JJ, Chen H, Sun LJ. Acute acromioclavicular joint dislocation treated with tightrope : Mini-open versus percutaneous stabilization. Acta Orthop Belg. 2019 Dec;85(4):406-411.</citation>
      <PMID>32374229</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mohamed Adel Abdelmajeed</investigator_full_name>
      <investigator_title>resident doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Dislocations</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019260
  org study id: Acute AC Joint disruption
  nct id: NCT06019260
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Compare the clinical and radiological outcome between the arthroscopic and open surgical
        repair using suture button device method in cases with acute AC joint disruption
  Acromioclavicular (AC) joint dislocation is a common shoulder injury, especially among
        athletes and has an estimated incidence of 17% of all shoulder injuries and30%-50% of
        athletic shoulder injuries ,In most cases, these are caused by a direct fall on the
        ipsilateral shoulder tip. The indirect mechanism of injury with an extended arm is rare, The
        Rockwood classification system is currently used and based on the degree and direction of the
        disrupted anatomy of the AC joint.
  
        Despite the high prevalence of this injury, there is no consensus about its optimal
        treatment. A variety of surgical procedures are described in the literature, such as an
        augmented suture with absorbable materials, stabilization with Kirschner (K)-wires in
        combination with or without additional wire loops, hook plates, or the Bosworth screw, but
        none can be considered the gold standard of operative AC joint stabilization, another
        treatment option was offered by the Tight Rope system, This technique was developed as a
        minimally invasive procedure in the management of AC dislocations. Because of its minimally
        invasive approach, it reduces soft tissue damage and yields better cosmetic results.9 Also,
        there is no need for reoperation to remove the hardware that might screws, or plates.
        Moreover, the complications of hardware failure, like breakage, dislocations, or bone
        fractures, are minimized
  observational model: Case-Control
  time perspective: Prospective
  measure: Radiological evaluation using the true anteroposterior view of the shoulder
  time frame: preoperative, three month postoperative and six month postoperative
  description: Radiological evaluation using the true anteroposterior view of the shoulder and AC projection (10 cephalic tilt with the beam centered over the AC joint)
  arm group label: group 1
  description: open surgical repair using suture button device method in acute acromioclavicular joint disruption
  arm group label: group 2
  description: arthroscopic assisted treatment of acute acromioclavicular joint disruption using suture button device
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Mohamed Adel abdelmajeed, residant
  phone: 01121650557
  email: mohamedadel@med.aun.edu.eg
  last name: Hatem Galal Zaki, Prof.Dr
  phone: 01221762266
  email: Said.hgz@aun.edu.eg
  citation: Jeong JY, Chun YM. Treatment of acute high-grade acromioclavicular joint dislocation. Clin Shoulder Elb. 2020 Sep 1;23(3):159-165. doi: 10.5397/cise.2020.00150. eCollection 2020 Sep.
  PMID: 33330252
  citation: Vijayan S, Kulkarni MS, Jain CP, Shetty S, Aroor MN, Rao SK. Bifocal Stabilisation of Acute Acromioclavicular Joint Dislocation using Suture Anchor and Temporary K-Wires: A Retrospective Analysis. Malays Orthop J. 2022 Nov;16(3):104-112. doi: 10.5704/MOJ.2211.016.
  PMID: 36589364
  citation: Bezruchenko S, Dolhopolov O, Yarova M, Luchko R, Mazevych V. Clinical Evaluation and Instrumental Diagnostics in Acute Acromioclavicular Joint Dislocation. Ortop Traumatol Rehabil. 2022 Feb 28;24(1):1-12. doi: 10.5604/01.3001.0015.7800.
  PMID: 35297375
  citation: Liu X, Huangfu X, Zhao J. Arthroscopic treatment of acute acromioclavicular joint dislocation by coracoclavicular ligament augmentation. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1460-6. doi: 10.1007/s00167-013-2800-9. Epub 2013 Dec 10.
  PMID: 24318508
  citation: Lu D, Wang T, Hong JJ, Chen H, Sun LJ. Acute acromioclavicular joint dislocation treated with tightrope : Mini-open versus percutaneous stabilization. Acta Orthop Belg. 2019 Dec;85(4):406-411.
  PMID: 32374229
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mohamed Adel Abdelmajeed
  investigator title: resident doctor
  mesh term: Joint Dislocations
  sharing ipd: No