<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/NCT02196233</url>
  </required_header>
  <id_info>
    <org_study_id>60239</org_study_id>
    <nct_id>NCT02196233</nct_id>
  </id_info>
  <brief_title>Surgical Treatment of Adult Trigger Finger</brief_title>
  <official_title>A Prospective, Randomized Trial Evaluating the Type of Incision on Outcomes and Patient Satisfaction in the Surgical Treatment of Trigger Finger</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trigger finger is a condition commonly treated with surgical intervention, yet no specific&#xD;
      incision type has been associated with improved or worsened scar quality or outcome.&#xD;
      Therefore, the investigators objective is to determine if the incision type may affect the&#xD;
      results of operative treatment of trigger finger. Therefore, the goals of this study are as&#xD;
      follows:&#xD;
&#xD;
      Primary Objective: To directly compare incision type (transverse vs. longitudinal) for&#xD;
      trigger finger release with scar quality and patient satisfaction via a validated scar&#xD;
      evaluation scale.&#xD;
&#xD;
      Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for&#xD;
      trigger finger release to patient outcome via a validated upper extremity outcome score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale</measure>
    <time_frame>1 Year Follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score</measure>
    <time_frame>1 Year Follow-up</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">86</enrollment>
  <condition>Trigger Finger</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients over the age of 18 presenting to the four attending surgeons with Trigger&#xD;
        Finger&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients over the age of 18 presenting to the four attending surgeons (Don&#xD;
             Coleman, Douglas Hutchinson, Andrew Tyser, Angela Wang) through either the University&#xD;
             of Utah Orthopaedic Center or the Veteran Affairs Hospital will be evaluated for&#xD;
             possible inclusion into the study&#xD;
&#xD;
          -  Patients who fail conservative treatment and elect to proceed with open surgical&#xD;
             release of the A1 pulley will be offered the option of being included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged less than 18, previous failed surgical A1 pulley release, and patients&#xD;
             receiving their care outside of the University of Utah Hospital system or the Veteran&#xD;
             Affairs Hospital&#xD;
&#xD;
          -  In addition, this study will evaluate trigger finger release; patients receiving&#xD;
             treatment for trigger thumb will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Hutchinson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopedic Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.</citation>
    <PMID>11476534</PMID>
  </reference>
  <reference>
    <citation>Ryzewicz M, Wolf JM. Trigger digits: principles, management, and complications. J Hand Surg Am. 2006 Jan;31(1):135-46. doi: 10.1016/j.jhsa.2005.10.013.</citation>
    <PMID>16443118</PMID>
  </reference>
  <reference>
    <citation>Sato ES, Gomes Dos Santos JB, Belloti JC, Albertoni WM, Faloppa F. Treatment of trigger finger: randomized clinical trial comparing the methods of corticosteroid injection, percutaneous release and open surgery. Rheumatology (Oxford). 2012 Jan;51(1):93-9. doi: 10.1093/rheumatology/ker315. Epub 2011 Oct 29.</citation>
    <PMID>22039269</PMID>
  </reference>
  <reference>
    <citation>Stefanich RJ, Peimer CA. Longitudinal incision for trigger finger release. J Hand Surg Am. 1989 Mar;14(2 Pt 1):316-7. doi: 10.1016/0363-5023(89)90030-0. No abstract available.</citation>
    <PMID>2703681</PMID>
  </reference>
  <reference>
    <citation>Turowski GA, Zdankiewicz PD, Thomson JG. The results of surgical treatment of trigger finger. J Hand Surg Am. 1997 Jan;22(1):145-9. doi: 10.1016/S0363-5023(05)80195-9.</citation>
    <PMID>9018628</PMID>
  </reference>
  <reference>
    <citation>Froimson, AI. Tenosynovitis and Tennis Elbow; in Green's Operative Hand Surgery, 3rd Edition.</citation>
  </reference>
  <reference>
    <citation>Bonnici AV, Spencer JD. A survey of 'trigger finger' in adults. J Hand Surg Br. 1988 May;13(2):202-3. doi: 10.1016/0266-7681_88_90139-8.</citation>
    <PMID>3385301</PMID>
  </reference>
  <reference>
    <citation>Bell MS. Trigger fingers: A checkmark incision. Can J Plast Surg. 2009 Fall;17(3):e18-9. No abstract available.</citation>
    <PMID>20808746</PMID>
  </reference>
  <reference>
    <citation>Brown E, Genoway KA. Impact of diabetes on outcomes in hand surgery. J Hand Surg Am. 2011 Dec;36(12):2067-72. doi: 10.1016/j.jhsa.2011.10.002.</citation>
    <PMID>22123050</PMID>
  </reference>
  <reference>
    <citation>Koh S, Nakamura S, Hattori T, Hirata H. Trigger digits in diabetes: their incidence and characteristics. J Hand Surg Eur Vol. 2010 May;35(4):302-5. doi: 10.1177/1753193409341103. Epub 2009 Aug 17.</citation>
    <PMID>19687073</PMID>
  </reference>
  <reference>
    <citation>Griggs SM, Weiss AP, Lane LB, Schwenker C, Akelman E, Sachar K. Treatment of trigger finger in patients with diabetes mellitus. J Hand Surg Am. 1995 Sep;20(5):787-9. doi: 10.1016/S0363-5023(05)80432-0.</citation>
    <PMID>8522745</PMID>
  </reference>
  <reference>
    <citation>Lim MH, Lim KK, Rasheed MZ, Narayanan S, Beng-Hoi Tan A. Outcome of open trigger digit release. J Hand Surg Eur Vol. 2007 Aug;32(4):457-9. doi: 10.1016/J.JHSB.2007.02.016. Epub 2007 May 4.</citation>
    <PMID>17482325</PMID>
  </reference>
  <reference>
    <citation>Stahl S, Kanter Y, Karnielli E. Outcome of trigger finger treatment in diabetes. J Diabetes Complications. 1997 Sep-Oct;11(5):287-90. doi: 10.1016/s1056-8727(96)00076-1.</citation>
    <PMID>9334911</PMID>
  </reference>
  <reference>
    <citation>van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.</citation>
    <PMID>16079683</PMID>
  </reference>
  <reference>
    <citation>van der Wal MB, Verhaegen PD, Middelkoop E, van Zuijlen PP. A clinimetric overview of scar assessment scales. J Burn Care Res. 2012 Mar-Apr;33(2):e79-87. doi: 10.1097/BCR.0b013e318239f5dd.</citation>
    <PMID>22249102</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Douglas Hutchinson</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Trigger Finger</keyword>
  <keyword>Prospective Clinical Research</keyword>
  <keyword>Randomized</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Transverse</keyword>
  <keyword>Longitudinal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigger Finger Disorder</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/NCT02196233
org study id: 60239
nct id: NCT02196233
lead sponsor: 
has dmc: No
Trigger finger is a condition commonly treated with surgical intervention, yet no specific
      incision type has been associated with improved or worsened scar quality or outcome.
      Therefore, the investigators objective is to determine if the incision type may affect the
      results of operative treatment of trigger finger. Therefore, the goals of this study are as
      follows:

      Primary Objective: To directly compare incision type (transverse vs. longitudinal) for
      trigger finger release with scar quality and patient satisfaction via a validated scar
      evaluation scale.

      Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for
      trigger finger release to patient outcome via a validated upper extremity outcome score.
observational model: Cohort
time perspective: Prospective
measure: Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale
time frame: 1 Year Follow-up
measure: Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score
time frame: 1 Year Follow-up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Douglas Hutchinson
role: Principal Investigator
affiliation: Orthopedic Surgery
facility: 
country: United States
citation: Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.
PMID: 11476534
citation: Ryzewicz M, Wolf JM. Trigger digits: principles, management, and complications. J Hand Surg Am. 2006 Jan;31(1):135-46. doi: 10.1016/j.jhsa.2005.10.013.
PMID: 16443118
citation: Sato ES, Gomes Dos Santos JB, Belloti JC, Albertoni WM, Faloppa F. Treatment of trigger finger: randomized clinical trial comparing the methods of corticosteroid injection, percutaneous release and open surgery. Rheumatology (Oxford). 2012 Jan;51(1):93-9. doi: 10.1093/rheumatology/ker315. Epub 2011 Oct 29.
PMID: 22039269
citation: Stefanich RJ, Peimer CA. Longitudinal incision for trigger finger release. J Hand Surg Am. 1989 Mar;14(2 Pt 1):316-7. doi: 10.1016/0363-5023(89)90030-0. No abstract available.
PMID: 2703681
citation: Turowski GA, Zdankiewicz PD, Thomson JG. The results of surgical treatment of trigger finger. J Hand Surg Am. 1997 Jan;22(1):145-9. doi: 10.1016/S0363-5023(05)80195-9.
PMID: 9018628
citation: Froimson, AI. Tenosynovitis and Tennis Elbow; in Green's Operative Hand Surgery, 3rd Edition.
citation: Bonnici AV, Spencer JD. A survey of 'trigger finger' in adults. J Hand Surg Br. 1988 May;13(2):202-3. doi: 10.1016/0266-7681_88_90139-8.
PMID: 3385301
citation: Bell MS. Trigger fingers: A checkmark incision. Can J Plast Surg. 2009 Fall;17(3):e18-9. No abstract available.
PMID: 20808746
citation: Brown E, Genoway KA. Impact of diabetes on outcomes in hand surgery. J Hand Surg Am. 2011 Dec;36(12):2067-72. doi: 10.1016/j.jhsa.2011.10.002.
PMID: 22123050
citation: Koh S, Nakamura S, Hattori T, Hirata H. Trigger digits in diabetes: their incidence and characteristics. J Hand Surg Eur Vol. 2010 May;35(4):302-5. doi: 10.1177/1753193409341103. Epub 2009 Aug 17.
PMID: 19687073
citation: Griggs SM, Weiss AP, Lane LB, Schwenker C, Akelman E, Sachar K. Treatment of trigger finger in patients with diabetes mellitus. J Hand Surg Am. 1995 Sep;20(5):787-9. doi: 10.1016/S0363-5023(05)80432-0.
PMID: 8522745
citation: Lim MH, Lim KK, Rasheed MZ, Narayanan S, Beng-Hoi Tan A. Outcome of open trigger digit release. J Hand Surg Eur Vol. 2007 Aug;32(4):457-9. doi: 10.1016/J.JHSB.2007.02.016. Epub 2007 May 4.
PMID: 17482325
citation: Stahl S, Kanter Y, Karnielli E. Outcome of trigger finger treatment in diabetes. J Diabetes Complications. 1997 Sep-Oct;11(5):287-90. doi: 10.1016/s1056-8727(96)00076-1.
PMID: 9334911
citation: van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
PMID: 16079683
citation: van der Wal MB, Verhaegen PD, Middelkoop E, van Zuijlen PP. A clinimetric overview of scar assessment scales. J Burn Care Res. 2012 Mar-Apr;33(2):e79-87. doi: 10.1097/BCR.0b013e318239f5dd.
PMID: 22249102
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Douglas Hutchinson
investigator title: M.D.
mesh term: Trigger Finger Disorder