<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/NCT03031015</url>
  </required_header>
  <id_info>
    <org_study_id>THHMU201701</org_study_id>
    <nct_id>NCT03031015</nct_id>
  </id_info>
  <brief_title>Cemented K-wire Fixation vs Plating for Finger Fractures</brief_title>
  <acronym>CKFPFF</acronym>
  <official_title>Randomized Comparison of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Qinhuangdao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Qinhuangdao</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>
      To introduce a novel external-fixation technique using the combination of K-wires and cement.&#xD;
      For comparison, we also included another group of patients who were treated using a mini&#xD;
      plate and screw system. Bone healing, range of motion of the fingers, costs of treatments,&#xD;
      and patient satisfaction were assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shaft fractures of the proximal phalanx are common injuries that may significantly affect&#xD;
      hand function. Good fracture stability to allow early mobilization of joints and thus early&#xD;
      return of function. The objective of this report is to introduce a novel external-fixation&#xD;
      technique using the combination of K-wires and cement. For comparison, we also included&#xD;
      another group of patients who were treated using a mini plate and screw system. A total of&#xD;
      104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51&#xD;
      patients). Patients in group A were treated with cemented K-wire fixation; and patients in&#xD;
      group B were treated with conventional mini-plate. Bone healing, range of motion of the&#xD;
      fingers, costs of treatments, and patient satisfaction were assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">May 1, 2014</completion_date>
  <primary_completion_date type="Actual">May 1, 2014</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>
    <intervention_model_description>Patients with proximal phalangeal fractures of fingers.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Bone healing</measure>
    <time_frame>Up to 12 weeks. From date of randomization until the date of first documented progression from any cause, which is assessed up to 12 weeks.</time_frame>
    <description>Time of bone healing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Joint motion</measure>
    <time_frame>Up to 2 years. From date of randomization until the date of second documented progression from any cause, which is assessed up to 2 years.</time_frame>
    <description>Range of motion of MCP, PIP, and DIP joints.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction.</measure>
    <time_frame>Up to 2 years. From date of randomization until the date of third documented progression from any cause, which is assessed up to 2 years.</time_frame>
    <description>Patient self assessment based on 100-mm visual analogue scale.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Closed Fracture of Finger</condition>
  <condition>Finger Fracture Open</condition>
  <arm_group>
    <arm_group_label>Cemented K-wire Fixation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The mean age of group A was 41 years (range, 18-63 years). There were 56 male and 11 female patients. The mean time from injury to operation was 5±4.53 days. Injured digits included index (n=24), long (n=19), ring (n=9), and little (n=15) fingers. Types of fractures were transversal (n=31), oblique or spiral (n=14), and comminuted (n=22) fractures. The patients were treated with Cemented K-wire Fixation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plating</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The mean age of group A was 39 years (range, 19-61 years). There were 51 male and 13 female patients. The mean time from injury to operation was 6±5.53 days. Injured digits included index (n=21), long (n=17), ring (n=10), and little (n=16) fingers. Types of fractures were transversal (n=34), oblique or spiral (n=11), and comminuted (n=19) fractures.The patients were treated with Plating.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cemented K-wire Fixation</intervention_name>
    <description>Fractures were reduced and then fixed with cemented K-wires.</description>
    <arm_group_label>Cemented K-wire Fixation</arm_group_label>
    <arm_group_label>Plating</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Plating</intervention_name>
    <description>Fractures were reduced and then fixed with Plate.</description>
    <arm_group_label>Cemented K-wire Fixation</arm_group_label>
    <arm_group_label>Plating</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient aged between 18 and 65 years;&#xD;
&#xD;
          -  acute fractures within 15 days;&#xD;
&#xD;
          -  closed fracture or open injury with small wound less than 1.5 cm;&#xD;
&#xD;
          -  involvement of proximal phalanges of index to little fingers; shaft fractures;&#xD;
&#xD;
          -  at least 5 mm in length of the most distal and proximal fragments so that the K-wires&#xD;
             or screws can be engaged;&#xD;
&#xD;
          -  oblique, spiral, and comminuted fractures;&#xD;
&#xD;
          -  normal opposite hand for comparison.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients younger than 18 years are excluded because of skeletal immaturity;&#xD;
&#xD;
          -  patients older than 65 years are excluded because of possible osteoporosis;&#xD;
&#xD;
          -  severe open injury or crush injuries; tendon or neurovascular injuries; - involvement&#xD;
             of articular surface;&#xD;
&#xD;
          -  old fractures exceeding 15 days because close reduction was most likely difficult;&#xD;
&#xD;
          -  a combined tendon, nerve, or artery injuries or diseases; diabetes, gout, ganglion;&#xD;
&#xD;
          -  osseous tumors, and other disease affecting bony structures and joint motion;&#xD;
&#xD;
          -  patients who declined to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xu Zhang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Third Hospital of Hebei Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xinzhong Shao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Third Hospital of Hebei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Third Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050051</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Miller L, Ada L, Crosbie J, Wajon A. Pattern of recovery after open reduction and internal fixation of proximal phalangeal fractures in the finger: a prospective longitudinal study. J Hand Surg Eur Vol. 2017 Feb;42(2):137-143. doi: 10.1177/1753193416670591. Epub 2016 Oct 4.</citation>
    <PMID>27702779</PMID>
  </results_reference>
  <results_reference>
    <citation>Borbas P, Dreu M, Poggetti A, Calcagni M, Giesen T. Treatment of proximal phalangeal fractures with an antegrade intramedullary screw: a cadaver study. J Hand Surg Eur Vol. 2016 Sep;41(7):683-7. doi: 10.1177/1753193416641319. Epub 2016 Apr 7. Erratum In: J Hand Surg Eur Vol. 2016 Sep;41(7):NP1.</citation>
    <PMID>27056278</PMID>
  </results_reference>
  <results_reference>
    <citation>Miller L, Crosbie J, Wajon A, Ada L. No difference between two types of exercise after proximal phalangeal fracture fixation: a randomised trial. J Physiother. 2016 Jan;62(1):12-9. doi: 10.1016/j.jphys.2015.11.006. Epub 2015 Dec 14.</citation>
    <PMID>26699692</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 21, 2017</last_update_submitted>
  <last_update_submitted_qc>January 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Reduction, Fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Fractures, Closed</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share the IPD data.</ipd_description>
  </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/NCT03031015
org study id: THHMU201701
nct id: NCT03031015
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To introduce a novel external-fixation technique using the combination of K-wires and cement.
      For comparison, we also included another group of patients who were treated using a mini
      plate and screw system. Bone healing, range of motion of the fingers, costs of treatments,
      and patient satisfaction were assessed.
Shaft fractures of the proximal phalanx are common injuries that may significantly affect
      hand function. Good fracture stability to allow early mobilization of joints and thus early
      return of function. The objective of this report is to introduce a novel external-fixation
      technique using the combination of K-wires and cement. For comparison, we also included
      another group of patients who were treated using a mini plate and screw system. A total of
      104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51
      patients). Patients in group A were treated with cemented K-wire fixation; and patients in
      group B were treated with conventional mini-plate. Bone healing, range of motion of the
      fingers, costs of treatments, and patient satisfaction were assessed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients with proximal phalangeal fractures of fingers.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: blinded
measure: Bone healing
time frame: Up to 12 weeks. From date of randomization until the date of first documented progression from any cause, which is assessed up to 12 weeks.
description: Time of bone healing.
measure: Joint motion
time frame: Up to 2 years. From date of randomization until the date of second documented progression from any cause, which is assessed up to 2 years.
description: Range of motion of MCP, PIP, and DIP joints.
measure: Patient satisfaction.
time frame: Up to 2 years. From date of randomization until the date of third documented progression from any cause, which is assessed up to 2 years.
description: Patient self assessment based on 100-mm visual analogue scale.
arm group label: Cemented K-wire Fixation
arm group type: Experimental
description: The mean age of group A was 41 years (range, 18-63 years). There were 56 male and 11 female patients. The mean time from injury to operation was 5±4.53 days. Injured digits included index (n=24), long (n=19), ring (n=9), and little (n=15) fingers. Types of fractures were transversal (n=31), oblique or spiral (n=14), and comminuted (n=22) fractures. The patients were treated with Cemented K-wire Fixation.
arm group label: Plating
arm group type: Active Comparator
description: The mean age of group A was 39 years (range, 19-61 years). There were 51 male and 13 female patients. The mean time from injury to operation was 6±5.53 days. Injured digits included index (n=21), long (n=17), ring (n=10), and little (n=16) fingers. Types of fractures were transversal (n=34), oblique or spiral (n=11), and comminuted (n=19) fractures.The patients were treated with Plating.
intervention type: Device
intervention name: Cemented K-wire Fixation
description: Fractures were reduced and then fixed with cemented K-wires.
arm group label: Cemented K-wire Fixation
arm group label: Plating
intervention type: Device
intervention name: Plating
description: Fractures were reduced and then fixed with Plate.
arm group label: Cemented K-wire Fixation
arm group label: Plating
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xu Zhang, MD
role: Study Chair
affiliation: Third Hospital of Hebei Medical University
last name: Xinzhong Shao, MD
role: Principal Investigator
affiliation: Third Hospital of Hebei Medical University
facility: 
country: China
citation: Miller L, Ada L, Crosbie J, Wajon A. Pattern of recovery after open reduction and internal fixation of proximal phalangeal fractures in the finger: a prospective longitudinal study. J Hand Surg Eur Vol. 2017 Feb;42(2):137-143. doi: 10.1177/1753193416670591. Epub 2016 Oct 4.
PMID: 27702779
citation: Borbas P, Dreu M, Poggetti A, Calcagni M, Giesen T. Treatment of proximal phalangeal fractures with an antegrade intramedullary screw: a cadaver study. J Hand Surg Eur Vol. 2016 Sep;41(7):683-7. doi: 10.1177/1753193416641319. Epub 2016 Apr 7. Erratum In: J Hand Surg Eur Vol. 2016 Sep;41(7):NP1.
PMID: 27056278
citation: Miller L, Crosbie J, Wajon A, Ada L. No difference between two types of exercise after proximal phalangeal fracture fixation: a randomised trial. J Physiother. 2016 Jan;62(1):12-9. doi: 10.1016/j.jphys.2015.11.006. Epub 2015 Dec 14.
PMID: 26699692
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Fractures, Closed
sharing ipd: No
ipd description: No plan to share the IPD data.