<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/NCT03757416</url>
  </required_header>
  <id_info>
    <org_study_id>15-110</org_study_id>
    <nct_id>NCT03757416</nct_id>
  </id_info>
  <brief_title>Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome</brief_title>
  <official_title>Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tennessee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect data on the clinical and functional outcomes of&#xD;
      surgical management for recurrent carpal tunnel syndrome (CTS) using flexor tenosynovectomy.&#xD;
      It is hypothesized that the outcomes of patients undergoing flexor tenosynovectomy for&#xD;
      recurrent CTS will compare favorably to published data regarding alternative types of&#xD;
      surgeries for the same condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary carpal tunnel release (CTR) is the most common surgical procedure of the hand, but&#xD;
      reported rates of symptom recurrence are not uncommon. Many surgical techniques have been&#xD;
      proposed and reported for management of carpal tunnel syndrome (CTS) symptom recurrence,&#xD;
      however there is a paucity of data on flexor tenosynovectomy for management of recurrent CTS.&#xD;
&#xD;
      This study will evaluate clinical and functional outcomes using information from pre- and&#xD;
      post-operative physical exams, surgery data, patient-reported satisfaction and symptoms, and&#xD;
      scores on functional measures, such as the Disabilities of the Arm, Shoulder, and Hand (DASH)&#xD;
      questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment; Physician practice relocating&#xD;
  </why_stopped>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of Symptoms</measure>
    <time_frame>one year</time_frame>
    <description>'Improvement of symptoms' versus 'No change/worsening of symptoms' of carpal tunnel syndrome following flexor tenosynovectomy. Improvement vs worsening of symptoms determined by subjective physician assessment at one-year follow-up as documented through office dictation in the medical record.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DASH (Disabilities of the Arm, Shoulder, and Hand) score</measure>
    <time_frame>one year</time_frame>
    <description>standard, validated patient-reported questionnaire evaluating arm/shoulder/hand function and quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient 'satisfaction'</measure>
    <time_frame>one year</time_frame>
    <description>Determined through patient/provider interview at one-year follow-up visit: Is the patient 'satisfied' with the results after surgery? (Yes or No)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Flexor tenosynovectomy surgery</arm_group_label>
    <description>Adult patients who will be undergoing flexor tenosynovectomy for the treatment of recurrent carpal tunnel syndrome and who have already undergone primary carpal tunnel release surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>If it has been determined that the patient will be undergoing flexor tenosynovectomy for the treatment of recurrent carpal tunnel syndrome, the patient will be asked to participate in this data collection study.</description>
    <arm_group_label>Flexor tenosynovectomy surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients of The Plastic Surgery Group/Hayes Hand Center at Erlanger Health System&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt; 18 years)&#xD;
&#xD;
          -  Patient of The Plastic Surgery Group/Hayes Hand Center&#xD;
&#xD;
          -  Previous diagnosis of Carpal Tunnel Syndrome&#xD;
&#xD;
          -  Diagnosis of Recurrent Carpal Tunnel Syndrome&#xD;
&#xD;
          -  Underwent primary carpal tunnel release&#xD;
&#xD;
          -  Undergoing isolated flexor tenosynovectomy as secondary procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had incomplete primary release of transverse carpal ligament&#xD;
&#xD;
          -  Had documented neuroma upon re-exploration&#xD;
&#xD;
          -  Had other soft tissue tumor within carpal tunnel or providing reasonable contribution&#xD;
             to neurologic symptoms&#xD;
&#xD;
          -  Experienced fracture or other traumatic injury to wrist after primary carpal tunnel&#xD;
             release&#xD;
&#xD;
          -  Diagnosis of osteomyelitis, infectious tenosynovitis or other infectious etiology to&#xD;
             area of interest after primary procedure&#xD;
&#xD;
          -  Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory&#xD;
             arthropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>D M Jemison, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee College of Medicine Chattanooga</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>May 3, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>recurrent</keyword>
  <keyword>carpal tunnel release</keyword>
  <keyword>flexor tenosynovectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03757416
org study id: 15-110
nct id: NCT03757416
lead sponsor: 
has dmc: No
The purpose of this study is to collect data on the clinical and functional outcomes of
      surgical management for recurrent carpal tunnel syndrome (CTS) using flexor tenosynovectomy.
      It is hypothesized that the outcomes of patients undergoing flexor tenosynovectomy for
      recurrent CTS will compare favorably to published data regarding alternative types of
      surgeries for the same condition.
Primary carpal tunnel release (CTR) is the most common surgical procedure of the hand, but
      reported rates of symptom recurrence are not uncommon. Many surgical techniques have been
      proposed and reported for management of carpal tunnel syndrome (CTS) symptom recurrence,
      however there is a paucity of data on flexor tenosynovectomy for management of recurrent CTS.

      This study will evaluate clinical and functional outcomes using information from pre- and
      post-operative physical exams, surgery data, patient-reported satisfaction and symptoms, and
      scores on functional measures, such as the Disabilities of the Arm, Shoulder, and Hand (DASH)
      questionnaire.
observational model: Case-Only
time perspective: Prospective
measure: Improvement of Symptoms
time frame: one year
description: 'Improvement of symptoms' versus 'No change/worsening of symptoms' of carpal tunnel syndrome following flexor tenosynovectomy. Improvement vs worsening of symptoms determined by subjective physician assessment at one-year follow-up as documented through office dictation in the medical record.
measure: DASH (Disabilities of the Arm, Shoulder, and Hand) score
time frame: one year
description: standard, validated patient-reported questionnaire evaluating arm/shoulder/hand function and quality of life
measure: Patient 'satisfaction'
time frame: one year
description: Determined through patient/provider interview at one-year follow-up visit: Is the patient 'satisfied' with the results after surgery? (Yes or No)
arm group label: Flexor tenosynovectomy surgery
description: Adult patients who will be undergoing flexor tenosynovectomy for the treatment of recurrent carpal tunnel syndrome and who have already undergone primary carpal tunnel release surgery.
intervention type: Other
intervention name: Data collection
description: If it has been determined that the patient will be undergoing flexor tenosynovectomy for the treatment of recurrent carpal tunnel syndrome, the patient will be asked to participate in this data collection study.
arm group label: Flexor tenosynovectomy surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: D M Jemison, MD
role: Principal Investigator
affiliation: University of Tennessee College of Medicine Chattanooga
responsible party type: Sponsor
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
sharing ipd: No