<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/NCT04457362</url>
  </required_header>
  <id_info>
    <org_study_id>20-00356</org_study_id>
    <nct_id>NCT04457362</nct_id>
  </id_info>
  <brief_title>Wrist Arthroscopy Study</brief_title>
  <official_title>A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the diagnostic efficacy of Arthrex NanoScope&#xD;
      compared to conventional arthroscopic instruments. Patients with wrist pathology who are&#xD;
      indicated for an arthroscopic procedure will be enrolled pre-operatively after a thorough&#xD;
      discussion of the study aims, risks, and benefits. At the time of surgery, under standard&#xD;
      conditions, using standard wrist arthroscopy portals, a diagnostic arthroscopy will be&#xD;
      performed with the Arthrex Nanoscope. The diagnostic arthroscopy will be performed in a&#xD;
      stepwise manner for consistency with notation of pathology and intended intervention. The&#xD;
      diagnostic arthroscopy will then be performed with the standard arthroscopic equipment, again&#xD;
      noting pathology and final intervention. Post-operatively, diagnostic accuracy, incidence of&#xD;
      change in intervention, and surgeon rated ease of use and confidence will be determined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2020</start_date>
  <completion_date type="Actual">March 22, 2023</completion_date>
  <primary_completion_date type="Actual">March 22, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective Cohort Study, Diagnostic</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy (%) of Nanoscope compared to conventional arthroscope</measure>
    <time_frame>1 Day</time_frame>
    <description>Diagnostic accuracy of the Arthrex Nanoscope will be described as a incidence/percentage compared to the diagnosis determined by wrist arthroscopy with conventional instruments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of change in intervention</measure>
    <time_frame>1 Day</time_frame>
    <description>&quot;Intended&quot; treatment and &quot;final&quot; treatment will be compared to determine if diagnostic variability would result in potential treatment variability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon rated ease of use</measure>
    <time_frame>1 Day</time_frame>
    <description>5 Point scale&#xD;
= very difficult&#xD;
= difficult&#xD;
= neutral&#xD;
= easy&#xD;
= very easy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon rated confidence of diagnosis</measure>
    <time_frame>1 Day</time_frame>
    <description>5 Point Scale&#xD;
= not at all confident&#xD;
= not very confident&#xD;
= neutral&#xD;
= fairly confident&#xD;
= very confident</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between pre-operative MRI findings and arthroscopic findings</measure>
    <time_frame>1 Day</time_frame>
    <description>Patients with pre-operative MRIs with a corresponding radiology report will be compared to arthroscopic findings to determination correlation between MRI and arthroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon rated visualization</measure>
    <time_frame>1 Day</time_frame>
    <description>5 point scale&#xD;
= unable to evaluate any structures&#xD;
= less than half of structures visualized&#xD;
= greater than half of structures visualized&#xD;
= all structures visualized, but not clearly&#xD;
= all structures clearly visualized</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Wrist Arthropathy</condition>
  <arm_group>
    <arm_group_label>Experimental Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic Arthroscopy using the Arthrex NanoScope</intervention_name>
    <description>A diagnostic arthroscopy will be performed with the Arthrex NanoScope.&#xD;
Structures evaluated:&#xD;
Radial styloid&#xD;
Proximal scaphoid articular cartilage&#xD;
Scaphoid fossa&#xD;
Radioscaphocapitate (RSC) ligament&#xD;
Long radiolunate (LRL) ligament&#xD;
Short radiolunate (SRL) ligament&#xD;
Scapholunate (SL) ligament&#xD;
Proximal lunate articular cartilage&#xD;
Lunate fossa&#xD;
Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make an initial diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, ligament injury and determine the intended treatment.</description>
    <arm_group_label>Experimental Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic Arthroscopy using standard arthroscopic instruments</intervention_name>
    <description>A diagnostic arthroscopy will be performed with the standard arthroscopic instruments.&#xD;
Structures evaluated:&#xD;
Radial styloid&#xD;
Proximal scaphoid articular cartilage&#xD;
Scaphoid fossa&#xD;
Radioscaphocapitate (RSC) ligament&#xD;
Long radiolunate (LRL) ligament&#xD;
Short radiolunate (SRL) ligament&#xD;
Scapholunate (SL) ligament&#xD;
Proximal lunate articular cartilage&#xD;
Lunate fossa&#xD;
Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make the final diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, and ligament injury and determine the final treatment.</description>
    <arm_group_label>Experimental Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years.&#xD;
&#xD;
          2. Wrist pathology based on clinical examination/imaging studies undergoing wrist&#xD;
             arthroscopy for further evaluation/treatment.&#xD;
&#xD;
          3. Willingness to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Age &lt; 18 years.&#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>Nader Paksima</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>beginning 9 months and ending 36 months following article publication</ipd_time_frame>
    <ipd_access_criteria>Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04457362
org study id: 20-00356
nct id: NCT04457362
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to evaluate the diagnostic efficacy of Arthrex NanoScope
      compared to conventional arthroscopic instruments. Patients with wrist pathology who are
      indicated for an arthroscopic procedure will be enrolled pre-operatively after a thorough
      discussion of the study aims, risks, and benefits. At the time of surgery, under standard
      conditions, using standard wrist arthroscopy portals, a diagnostic arthroscopy will be
      performed with the Arthrex Nanoscope. The diagnostic arthroscopy will be performed in a
      stepwise manner for consistency with notation of pathology and intended intervention. The
      diagnostic arthroscopy will then be performed with the standard arthroscopic equipment, again
      noting pathology and final intervention. Post-operatively, diagnostic accuracy, incidence of
      change in intervention, and surgeon rated ease of use and confidence will be determined.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective Cohort Study, Diagnostic
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic accuracy (%) of Nanoscope compared to conventional arthroscope
time frame: 1 Day
description: Diagnostic accuracy of the Arthrex Nanoscope will be described as a incidence/percentage compared to the diagnosis determined by wrist arthroscopy with conventional instruments.
measure: Incidence of change in intervention
time frame: 1 Day
description: "Intended" treatment and "final" treatment will be compared to determine if diagnostic variability would result in potential treatment variability.
measure: Surgeon rated ease of use
time frame: 1 Day
description: 5 Point scale
= very difficult
= difficult
= neutral
= easy
= very easy
measure: Surgeon rated confidence of diagnosis
time frame: 1 Day
description: 5 Point Scale
= not at all confident
= not very confident
= neutral
= fairly confident
= very confident
measure: Correlation between pre-operative MRI findings and arthroscopic findings
time frame: 1 Day
description: Patients with pre-operative MRIs with a corresponding radiology report will be compared to arthroscopic findings to determination correlation between MRI and arthroscopy.
measure: Surgeon rated visualization
time frame: 1 Day
description: 5 point scale
= unable to evaluate any structures
= less than half of structures visualized
= greater than half of structures visualized
= all structures visualized, but not clearly
= all structures clearly visualized
arm group label: Experimental Cohort
arm group type: Experimental
description: Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy
intervention type: Diagnostic Test
intervention name: Diagnostic Arthroscopy using the Arthrex NanoScope
description: A diagnostic arthroscopy will be performed with the Arthrex NanoScope.
Structures evaluated:
Radial styloid
Proximal scaphoid articular cartilage
Scaphoid fossa
Radioscaphocapitate (RSC) ligament
Long radiolunate (LRL) ligament
Short radiolunate (SRL) ligament
Scapholunate (SL) ligament
Proximal lunate articular cartilage
Lunate fossa
Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make an initial diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, ligament injury and determine the intended treatment.
arm group label: Experimental Cohort
intervention type: Diagnostic Test
intervention name: Diagnostic Arthroscopy using standard arthroscopic instruments
description: A diagnostic arthroscopy will be performed with the standard arthroscopic instruments.
Structures evaluated:
Radial styloid
Proximal scaphoid articular cartilage
Scaphoid fossa
Radioscaphocapitate (RSC) ligament
Long radiolunate (LRL) ligament
Short radiolunate (SRL) ligament
Scapholunate (SL) ligament
Proximal lunate articular cartilage
Lunate fossa
Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make the final diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, and ligament injury and determine the final treatment.
arm group label: Experimental Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nader Paksima
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Joint Diseases
sharing ipd: Yes
ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: beginning 9 months and ending 36 months following article publication
ipd access criteria: Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.