<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/NCT03763552</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH ID 2017-02003</org_study_id>
    <nct_id>NCT03763552</nct_id>
  </id_info>
  <brief_title>Arthroscopic Midcarpal Wrist Arthrodesis: Clinical and Functional Outcomes</brief_title>
  <official_title>Arthroscopic Midcarpal Wrist Arthrodesis: Clinical and Functional Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      All cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist&#xD;
      fusion with cannulated screws from January 2015 to December 2017 will be reviewed.&#xD;
&#xD;
      The union rate and time to union will be recorded following the standard radiological&#xD;
      postoperative control. Wrist assessments performed pre- and postoperative regarding strength,&#xD;
      range of motion and pain will be analysed. Complications will be recorded as well.&#xD;
&#xD;
      Participants will be recruited for wrist assessment. They will be asked to fill out&#xD;
      questionnaires about the functional result related to their quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 13, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Wrist range of motion after surgery</measure>
    <time_frame>5 minutes</time_frame>
    <description>Extension , Flexion, Radial and ulnar deviation, Pronation , Supination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hand strength after surgery</measure>
    <time_frame>2 minutes</time_frame>
    <description>Strength measurement in kilos (Kg) with Jamar Dynamometer placed in Scale 2. Three consecutive trials will be executed, the best result (higher strength in kilos) will be registered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment in weight bearing (Visual analogue scale, VAS)</measure>
    <time_frame>1 minute</time_frame>
    <description>The patients will be asked to evaluate the pain in the wrist by full weight bearing, according to visual analogue scale (VAS 0-10, 0 means no pain, 10 means maximum pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function assessment through DASH (The disabilities of the arm, shoulder, hand) questionnaire</measure>
    <time_frame>5 minutes</time_frame>
    <description>This questionnaire asks about patient's symptoms as well as their ability to perform certain activities in the last week. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). The response to the first 30 items of the DASH are added to form the raw, or actual, score. A minimum score is 30; a maximum is 150.The raw score is then transformed to a zero-to-100 scale with zero reflecting no disability (good function) and 100 reflecting maximum disability.&#xD;
The maximum score of the second section is 20 with a minimum of 4. The range of scores is therefore 16. This score is also transformed to a zero-to-100 scale with lower scores reflecting minimal disability, and higher scores reflecting more disability.</description>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Dislocation of Midcarpal Joint</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>arthroscopic wrist arthrodesis</intervention_name>
    <description>Cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All cases of arthroscopic mid-carpal wrist arthrodesis for mid-carpal arthritis, related to&#xD;
        post-traumatic or degenerative carpal deformity, performed in our Division from January&#xD;
        2015 to October 2017 will be studied. The approximate number of participants will be 15.&#xD;
        There will be no control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All the patients suffered from traumatic or degenerative mid-carpal wrist arthritis or&#xD;
             instability and treated surgically with arthroscopic midcarpal wrist arthrodesis in&#xD;
             the Division of Plastic Surgery and Hand Surgery University Hospital Zürich from&#xD;
             January 2015 to October 2017 will be included.&#xD;
&#xD;
          2. Signed informed consent for participation in the study and for further use of&#xD;
             collected data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Missing Informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Olga Politikou</name>
      <address>
        <city>Zürich</city>
        <state>Schweiz</state>
        <zip>8002</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>del Pinal F, Tandioy-Delgado F. (Dry) arthroscopic partial wrist arthrodesis: tips and tricks. Handchir Mikrochir Plast Chir. 2014 Oct;46(5):300-6. doi: 10.1055/s-0034-1387707. Epub 2014 Oct 7.</citation>
    <PMID>25290275</PMID>
  </results_reference>
  <results_reference>
    <citation>del Pinal F, Klausmeyer M, Thams C, Moraleda E, Galindo C. Early experience with (dry) arthroscopic 4-corner arthrodesis: from a 4-hour operation to a tourniquet time. J Hand Surg Am. 2012 Nov;37(11):2389-99. doi: 10.1016/j.jhsa.2012.08.026.</citation>
    <PMID>23101536</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>arthroscopy</keyword>
  <keyword>wrist osteoarthrosis</keyword>
  <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>


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/NCT03763552
org study id: KEK-ZH ID 2017-02003
nct id: NCT03763552
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
All cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist
      fusion with cannulated screws from January 2015 to December 2017 will be reviewed.

      The union rate and time to union will be recorded following the standard radiological
      postoperative control. Wrist assessments performed pre- and postoperative regarding strength,
      range of motion and pain will be analysed. Complications will be recorded as well.

      Participants will be recruited for wrist assessment. They will be asked to fill out
      questionnaires about the functional result related to their quality of life.
observational model: Case-Only
time perspective: Retrospective
measure: Wrist range of motion after surgery
time frame: 5 minutes
description: Extension , Flexion, Radial and ulnar deviation, Pronation , Supination
measure: Hand strength after surgery
time frame: 2 minutes
description: Strength measurement in kilos (Kg) with Jamar Dynamometer placed in Scale 2. Three consecutive trials will be executed, the best result (higher strength in kilos) will be registered.
measure: Pain assessment in weight bearing (Visual analogue scale, VAS)
time frame: 1 minute
description: The patients will be asked to evaluate the pain in the wrist by full weight bearing, according to visual analogue scale (VAS 0-10, 0 means no pain, 10 means maximum pain)
measure: Function assessment through DASH (The disabilities of the arm, shoulder, hand) questionnaire
time frame: 5 minutes
description: This questionnaire asks about patient's symptoms as well as their ability to perform certain activities in the last week. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). The response to the first 30 items of the DASH are added to form the raw, or actual, score. A minimum score is 30; a maximum is 150.The raw score is then transformed to a zero-to-100 scale with zero reflecting no disability (good function) and 100 reflecting maximum disability.
The maximum score of the second section is 20 with a minimum of 4. The range of scores is therefore 16. This score is also transformed to a zero-to-100 scale with lower scores reflecting minimal disability, and higher scores reflecting more disability.
intervention type: Other
intervention name: arthroscopic wrist arthrodesis
description: Cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
citation: del Pinal F, Tandioy-Delgado F. (Dry) arthroscopic partial wrist arthrodesis: tips and tricks. Handchir Mikrochir Plast Chir. 2014 Oct;46(5):300-6. doi: 10.1055/s-0034-1387707. Epub 2014 Oct 7.
PMID: 25290275
citation: del Pinal F, Klausmeyer M, Thams C, Moraleda E, Galindo C. Early experience with (dry) arthroscopic 4-corner arthrodesis: from a 4-hour operation to a tourniquet time. J Hand Surg Am. 2012 Nov;37(11):2389-99. doi: 10.1016/j.jhsa.2012.08.026.
PMID: 23101536
responsible party type: Sponsor
mesh term: Joint Dislocations
sharing ipd: No