<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/NCT04482868</url>
  </required_header>
  <id_info>
    <org_study_id>2017-09-03</org_study_id>
    <nct_id>NCT04482868</nct_id>
  </id_info>
  <brief_title>Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance</brief_title>
  <official_title>Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebei Medical University</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 scaphoid is the most common fractured carpal bone in active adults, accounting for up to&#xD;
      80% of all carpal fractures. The optimum treatment approach of the acute scaphoid fractures&#xD;
      is under discussion. Cast immobilization is the main treatment for non-displaced scaphoid&#xD;
      fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment.&#xD;
      Long periods of cast immobilization may result in wrist stiffness, loss of grip strength,&#xD;
      muscle atrophy and disuse osteopenia. Operative treatment for displaced and unstable scaphoid&#xD;
      fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent&#xD;
      disadvantages of ligament and capsular dissection, blood vessels damage. This study&#xD;
      introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. We&#xD;
      used one K-wire maintaining the reduction of the scaphoid fractures throughout the entire&#xD;
      process of drilling and screw insertion and screw fixation for acute scaphoid fractures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 29, 2018</completion_date>
  <primary_completion_date type="Actual">September 6, 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The modified Mayo wrist scoring system</measure>
    <time_frame>3 months</time_frame>
    <description>The function outcomes including pain, work status, range of motion (Rom) and grip strength were assessed and graded as excellent, good , fair and poor.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hand</condition>
  <condition>Wrist</condition>
  <condition>Wounds and Injuries</condition>
  <arm_group>
    <arm_group_label>open reduction group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>percutaneous group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous screw fixation through K-wire-assisted reduction and maintenance</intervention_name>
    <description>Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance</description>
    <arm_group_label>open reduction group</arm_group_label>
    <arm_group_label>percutaneous group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute scaphoid fractures&#xD;
&#xD;
          -  Injury to surgery less than 7 days&#xD;
&#xD;
          -  Only one injured hand&#xD;
&#xD;
          -  Written informed consent to undergo the surgical procedure&#xD;
&#xD;
          -  Patients of either sex aged between 18 and 70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with vascular injuried requiring revascularization&#xD;
&#xD;
          -  Concomitant phalanx fractures or other injuries needing immobilization&#xD;
&#xD;
          -  Loss of skin substance requiring grafts or flaps&#xD;
&#xD;
          -  Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders&#xD;
&#xD;
          -  Smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunjie Liu, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Hebei Medical University</affiliation>
  </overall_official>
  <reference>
    <citation>Yu Y, Cui H, Yang X, Yu X, Bai Y. A novel percutaneous achievement and maintenance of reduction and screw fixation for acute displaced scaphoid fractures: minimum two-year follow-up. Int Orthop. 2018 Aug;42(8):1911-1916. doi: 10.1007/s00264-018-3758-5. Epub 2018 Jan 10.</citation>
    <PMID>29318360</PMID>
  </reference>
  <reference>
    <citation>Merrell G, Slade J. Technique for percutaneous fixation of displaced and nondisplaced acute scaphoid fractures and select nonunions. J Hand Surg Am. 2008 Jul-Aug;33(6):966-73. doi: 10.1016/j.jhsa.2008.04.023.</citation>
    <PMID>18656774</PMID>
  </reference>
  <reference>
    <citation>Morsy M, Sabbagh MD, van Alphen NA, Laungani AT, Kadar A, Moran SL. The Vascular Anatomy of the Scaphoid: New Discoveries Using Micro-Computed Tomography Imaging. J Hand Surg Am. 2019 Nov;44(11):928-938. doi: 10.1016/j.jhsa.2019.08.001. Epub 2019 Sep 19.</citation>
    <PMID>31543293</PMID>
  </reference>
  <reference>
    <citation>Garcia RM, Ruch DS. Management of scaphoid fractures in the athlete: open and percutaneous fixation. Sports Med Arthrosc Rev. 2014 Mar;22(1):22-8. doi: 10.1097/JSA.0000000000000008.</citation>
    <PMID>24651287</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 12, 2020</last_update_submitted>
  <last_update_submitted_qc>August 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hebei Medical University</investigator_affiliation>
    <investigator_full_name>Chunjie Liu</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04482868
org study id: 2017-09-03
nct id: NCT04482868
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The scaphoid is the most common fractured carpal bone in active adults, accounting for up to
      80% of all carpal fractures. The optimum treatment approach of the acute scaphoid fractures
      is under discussion. Cast immobilization is the main treatment for non-displaced scaphoid
      fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment.
      Long periods of cast immobilization may result in wrist stiffness, loss of grip strength,
      muscle atrophy and disuse osteopenia. Operative treatment for displaced and unstable scaphoid
      fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent
      disadvantages of ligament and capsular dissection, blood vessels damage. This study
      introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. We
      used one K-wire maintaining the reduction of the scaphoid fractures throughout the entire
      process of drilling and screw insertion and screw fixation for acute scaphoid fractures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The modified Mayo wrist scoring system
time frame: 3 months
description: The function outcomes including pain, work status, range of motion (Rom) and grip strength were assessed and graded as excellent, good , fair and poor.
arm group label: open reduction group
arm group type: Placebo Comparator
arm group label: percutaneous group
arm group type: Experimental
intervention type: Procedure
intervention name: Percutaneous screw fixation through K-wire-assisted reduction and maintenance
description: Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance
arm group label: open reduction group
arm group label: percutaneous group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chunjie Liu, M.D.
role: Study Chair
affiliation: Hebei Medical University
citation: Yu Y, Cui H, Yang X, Yu X, Bai Y. A novel percutaneous achievement and maintenance of reduction and screw fixation for acute displaced scaphoid fractures: minimum two-year follow-up. Int Orthop. 2018 Aug;42(8):1911-1916. doi: 10.1007/s00264-018-3758-5. Epub 2018 Jan 10.
PMID: 29318360
citation: Merrell G, Slade J. Technique for percutaneous fixation of displaced and nondisplaced acute scaphoid fractures and select nonunions. J Hand Surg Am. 2008 Jul-Aug;33(6):966-73. doi: 10.1016/j.jhsa.2008.04.023.
PMID: 18656774
citation: Morsy M, Sabbagh MD, van Alphen NA, Laungani AT, Kadar A, Moran SL. The Vascular Anatomy of the Scaphoid: New Discoveries Using Micro-Computed Tomography Imaging. J Hand Surg Am. 2019 Nov;44(11):928-938. doi: 10.1016/j.jhsa.2019.08.001. Epub 2019 Sep 19.
PMID: 31543293
citation: Garcia RM, Ruch DS. Management of scaphoid fractures in the athlete: open and percutaneous fixation. Sports Med Arthrosc Rev. 2014 Mar;22(1):22-8. doi: 10.1097/JSA.0000000000000008.
PMID: 24651287
responsible party type: Principal Investigator
investigator affiliation: Hebei Medical University
investigator full name: Chunjie Liu
investigator title: Chief physician
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)