xml: <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/NCT06002009</url>
    </required_header>
    <id_info>
      <org_study_id>3103</org_study_id>
      <nct_id>NCT06002009</nct_id>
    </id_info>
    <brief_title>SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function</brief_title>
    <acronym>SSCuFF</acronym>
    <official_title>SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospitals of North Midlands NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospitals of North Midlands NHS Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of the study is to determine in adult patients with a rotator cuff&#xD;
        tear, what size and pattern of rotator cuff tear would result in damage to the suprascapular&#xD;
        nerve.&#xD;
  &#xD;
        The secondary objectives are&#xD;
  &#xD;
          1. To determine if an injured suprascapular nerve can recover if the rotator cuff tear is&#xD;
             surgically repaired.&#xD;
  &#xD;
          2. To determine if there is a limit of retraction before the suprascapular nerve is&#xD;
             irreversibly damaged.&#xD;
  &#xD;
          3. To determine factors that are protective against SSN injury.&#xD;
  &#xD;
          4. Can the patient data gathered be used to optimise operative procedures.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2029</completion_date>
    <primary_completion_date type="Anticipated">September 2028</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>Assess suprascapular nerve funaction</measure>
      <time_frame>36 months</time_frame>
      <description>MRI scan to quantify size of rotator cuff tear, compared with Nerve Conduction Studies (NCS) to assess suprascapular nerve function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Shoulder scores</measure>
      <time_frame>36 months</time_frame>
      <description>Compare functional shoulder scores to the degree of nerve injury and muscle degeneration over a 24-month period post-injury. Scores to include active range of movement (ROM) measurements; and the collection of validated shoulder outcome scores (DASH, OSS, &amp; Constant score).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nerve recovery</measure>
      <time_frame>24 months</time_frame>
      <description>Functional assessment of nerve recovery at 24 months post-injury for surgically repaired rotator cuff tears.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Machine learning</measure>
      <time_frame>24 months</time_frame>
      <description>Use of machine learning to investigate data set for optimum parameters or predictors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nerve conduction studies</measure>
      <time_frame>12 months</time_frame>
      <description>Repeat Nerve Conduction Study investigations at 12 months post injury for all surgically managed participants and non-surgical patients to assess suprascapular nerve function</description>
    </secondary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Orthopedic Disorder</condition>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>MRI</intervention_name>
      <description>MRI of shoulder</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nerve conduction study</intervention_name>
      <description>Nerve conduction study</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants will be recruited from the University Hospitals of North Midlands outpatient&#xD;
          clinic&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • All patients age ≥18 years presenting to a UHNM shoulder clinic with a confirmed&#xD;
          diagnosis of a rotator cuff tear (affecting one or both shoulders).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Bony pathology (such as significant shoulder arthritis that would exclude isolated&#xD;
               rotator cuff repair)&#xD;
  &#xD;
            -  Grossly abnormal shoulder anatomy&#xD;
  &#xD;
            -  Motor Neurone Disease&#xD;
  &#xD;
            -  Cervical cord disease affecting the SSN nerve roots&#xD;
  &#xD;
            -  Patients unable to undergo MRI scan&#xD;
  &#xD;
            -  Previous surgery at the affected glenohumeral joint&#xD;
  &#xD;
            -  Patients unable to tolerate NCS&#xD;
  &#xD;
            -  Acute fracture affecting the glenohumeral joint&#xD;
  &#xD;
            -  Recent glenohumeral joint dislocation (past 12 months)&#xD;
  &#xD;
            -  Patients unable or unwilling to give full informed consent&#xD;
  &#xD;
            -  Patients unable or unwilling to comply with the study procedures&#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>Damian McClelland</last_name>
      <role>Study Chair</role>
      <affiliation>University Hospital of North Midlands NHS Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Megan Young</last_name>
      <phone>01782 675384</phone>
      <email>megan.young@uhnm.nhs.uk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rotator cuff tear</keyword>
    <keyword>Suprascapular nerve function</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Diseases</mesh_term>
      <mesh_term>Rotator Cuff Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002009
  org study id: 3103
  nct id: NCT06002009
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of the study is to determine in adult patients with a rotator cuff
        tear, what size and pattern of rotator cuff tear would result in damage to the suprascapular
        nerve.
  
        The secondary objectives are
  
          1. To determine if an injured suprascapular nerve can recover if the rotator cuff tear is
             surgically repaired.
  
          2. To determine if there is a limit of retraction before the suprascapular nerve is
             irreversibly damaged.
  
          3. To determine factors that are protective against SSN injury.
  
          4. Can the patient data gathered be used to optimise operative procedures.
  observational model: Cohort
  time perspective: Prospective
  measure: Assess suprascapular nerve funaction
  time frame: 36 months
  description: MRI scan to quantify size of rotator cuff tear, compared with Nerve Conduction Studies (NCS) to assess suprascapular nerve function.
  measure: Shoulder scores
  time frame: 36 months
  description: Compare functional shoulder scores to the degree of nerve injury and muscle degeneration over a 24-month period post-injury. Scores to include active range of movement (ROM) measurements; and the collection of validated shoulder outcome scores (DASH, OSS, & Constant score).
  measure: Nerve recovery
  time frame: 24 months
  description: Functional assessment of nerve recovery at 24 months post-injury for surgically repaired rotator cuff tears.
  measure: Machine learning
  time frame: 24 months
  description: Use of machine learning to investigate data set for optimum parameters or predictors
  measure: Nerve conduction studies
  time frame: 12 months
  description: Repeat Nerve Conduction Study investigations at 12 months post injury for all surgically managed participants and non-surgical patients to assess suprascapular nerve function
  intervention type: Radiation
  intervention name: MRI
  description: MRI of shoulder
  intervention type: Other
  intervention name: Nerve conduction study
  description: Nerve conduction study
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Damian McClelland
  role: Study Chair
  affiliation: University Hospital of North Midlands NHS Trust
  last name: Megan Young
  phone: 01782 675384
  email: megan.young@uhnm.nhs.uk
  responsible party type: Sponsor
  mesh term: Musculoskeletal Diseases
  mesh term: Rotator Cuff Injuries
  sharing ipd: No