<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/NCT03001050</url>
  </required_header>
  <id_info>
    <org_study_id>5160379</org_study_id>
    <nct_id>NCT03001050</nct_id>
  </id_info>
  <brief_title>Rotator Cuff: Does the Vascularity Matter and the Role for PINPOINT</brief_title>
  <official_title>Rotator Cuff: Does the Vascularity Matter and the Role for PINPOINT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nirav Amin, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of doing this study is to improve long term patient function and outcomes in&#xD;
      the healing rates of Rotator Cuffs. The investigators would also like to see if this method&#xD;
      can be more cost effective and time efficient for Rotator Cuff evaluation during arthroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background or rationale for this study:&#xD;
&#xD;
      4.5 million Patient's seek medical care for shoulder pain annually in the United States.&#xD;
&#xD;
      250,000 patients receive rotator cuff surgery in the United States annually. Those rotator&#xD;
      cuff surgeries produce a societal savings of $3.44 billion per year; averaging $13,771.00 per&#xD;
      patient younger than age 61. In which case rotator cuff tears Increases with age.&#xD;
&#xD;
      The Societal and Economic Value of Rotator Cuff Repair (AAOS) 2015 Rotator cuff repairs&#xD;
      result in a lifetime societal savings in the U.S. of approximately $3.44 billion annually.&#xD;
      Societal savings offset the direct costs of treatment in patients younger than age 61,&#xD;
      resulting in an average net savings of $13,771 per patient. This number significantly&#xD;
      increased to $77,662.00 for patients younger than 40 years of age.&#xD;
&#xD;
      Common problem, a 55 year-old man injured his left arm. He uses a sling and has difficulties&#xD;
      performing simple activities. 1 week later he falls develops immediate pain in his shoulder.&#xD;
      On examination he is unable to move his left arm in any upward or sideways direction without&#xD;
      supporting it with his other arm. Radiographs he brought show no signs of shoulder&#xD;
      osteoarthritis, dislocation, or fracture.&#xD;
&#xD;
      Shoulder pain is the third most common musculoskeletal reason for seeking medical care.&#xD;
      Although smaller tears are less likely to propagate, larger tears tend to progress with time&#xD;
      and eventually may become irreparable because of significant tendon retraction, muscle&#xD;
      atrophy, or both or when the tendons tissue quality does not allow repair.&#xD;
&#xD;
      In 1972-Neer proposed that 95% of rotator cuff injuries were caused by mechanical compression&#xD;
      under the coracoacromial arch, others argued cuff tear caused spur formation.&#xD;
&#xD;
        -  Type I-flat&#xD;
&#xD;
        -  Type II-curved&#xD;
&#xD;
        -  Type III-hooked&#xD;
&#xD;
      Multifactorial:&#xD;
&#xD;
      Extrinsic factors;&#xD;
&#xD;
        -  Subacromial impingement&#xD;
&#xD;
        -  Glenohumeral instability&#xD;
&#xD;
        -  Internal impingement&#xD;
&#xD;
        -  Trauma (acute/repetitive) Intrinsic Factors;&#xD;
&#xD;
        -  Tendon vascular supply&#xD;
&#xD;
        -  Collagen fiber abnormalities&#xD;
&#xD;
      A positive painful arc test result and positive external rotation resistance test result were&#xD;
      the most accurate finding for detecting Rotator Cuff Disease; whereas the presence of a&#xD;
      positive lag tests (external or internal rotation) result was most accurate for diagnosis of&#xD;
      a full-thickness rotator cuff tear. Differentiating a full thickness tear from a partial&#xD;
      tear, the most sensitive test was the belly-press test (56.8%), and the most specific was the&#xD;
      lift-off test (96.95).&#xD;
&#xD;
      Bone microvascularization of the footprint plays a role in rotator Cuff healing. The use of&#xD;
      the Pinpoint may play a pivotal role in rotator Cuff healing, en lieu of Plasma Rich&#xD;
      platelets with variable results based on concentration levels.&#xD;
&#xD;
      6 level randomized controlled trials showed no clinically significant differences in Constant&#xD;
      scores, University of California, Los Angles shoulder rating (UCLA), and American Shoulder&#xD;
      and Elbow Surgeons (ASES) scores between double-row and single-row rotator cuff repair.&#xD;
      Overall odds ratio (OR) of intact rotator cuff tendon healing was 1.93 in patients treated&#xD;
      with double-row versus single-row repair, and the difference was significant.&#xD;
&#xD;
      A statistically significant benefit of double-row repair in the ASES and UCLA scores was&#xD;
      observed in the subgroup with tears greater than 3cm. The take home point; Double row may&#xD;
      improve structural healing: Clinical Relevance?&#xD;
&#xD;
      9 studies in the meta-analysis, 5 of which were randomized prospective studies (LEVEL1).&#xD;
&#xD;
      Double-row rotator cuff repair techniques have a significantly lower re-tear rate, higher&#xD;
      ASES score and greater range of motion of internal rotation compared with single-row repair&#xD;
      techniques. Point: Especially in those rotator cuff tears with a size &gt;30mm, the double-row&#xD;
      technique is recommended for repair.&#xD;
&#xD;
      This was a Level 4 study out of the Cleveland Clinic which showed the majority of the tears&#xD;
      occurred between 6 and 24 weeks. The role of a potential hand held device can assess the&#xD;
      tendon quality in the office and change the rehab protocols based on tendon retraction.&#xD;
&#xD;
      Role for study interventions:&#xD;
&#xD;
        -  Assessing the bony vascularity at the footprint and the tendon integrity.&#xD;
&#xD;
        -  Current standard of care:&#xD;
&#xD;
      Steroid injection as a non-operatively treatment option. Could the steroid injections be&#xD;
      affecting the tendon micro vascularization? Could using the Pinpoint assess tendon quality&#xD;
      and long term healing a potential.&#xD;
&#xD;
        -  Cystic osseous resorption and osteolysis.&#xD;
&#xD;
        -  Breakdown products (PLLA) cause synovitis and chondrolysis.&#xD;
&#xD;
        -  Breakdown products (PLLA) may interfere with healing-Complications of Bioabsorbable&#xD;
           Suture anchors in the shoulder.&#xD;
&#xD;
      Why Medical Row Knots?&#xD;
&#xD;
        -  Enhances Biology be sealing footprint from synovial fluid.&#xD;
&#xD;
        -  Compared to knotless medical row, better biomechanics incl. load to failure, stiffness,&#xD;
           less gap formation.&#xD;
&#xD;
        -  A biomechanical comparison of 2 technical of double-row rotator cuff fixation: the&#xD;
           importance of medical row knots.&#xD;
&#xD;
      Clinical Implications and Surgeon's Role;&#xD;
&#xD;
        -  Choice of a tissue-penetrating instrument; smaller penetrating devices resulting in&#xD;
           improves characteristics of stitch holding strength.&#xD;
&#xD;
        -  Size of the tissue bite; bigger bite size being stronger.&#xD;
&#xD;
        -  Most critical variable under a surgeons control during a rotator cuff repair is the&#xD;
           choice of the stitch.&#xD;
&#xD;
      Role for Pinpoint:&#xD;
&#xD;
      In the re-tear and partial-repair groups, postoperative tendon preservation at the middle&#xD;
      fact significantly affected the Japanese Orthopaedic Assocation (JOA) and UCLA scores&#xD;
      (P=.014, respectively). Considering the patients with tendon healing had better clinical&#xD;
      factors, the Pinpoint may help identify the tendon and footprint vascularity at time of&#xD;
      surgery.&#xD;
&#xD;
      Goals for the Pinpoint:&#xD;
&#xD;
      To attempt to show that increased vascularity may have an effect of the muscle quality,&#xD;
      therefore improving the strength and function long term.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
        -  This prospective study aims to obtain the accurate level within a range of a 95% CI&#xD;
           imaging Rotator Cuff tendons and the footprint.&#xD;
&#xD;
        -  Ensure the Vascularity of the tendon after the footprint and the tendon have been&#xD;
           restored to the anatomic footprint. See if the level of the Rotator Cuff bite affects&#xD;
           the vascular flow of the tendon.&#xD;
&#xD;
        -  Does tying the medical row or excessive tension change the vascularity of the Rotator&#xD;
           Cuff.&#xD;
&#xD;
        -  We would like to see if by using the Pinpoint system it may be more cost effective then&#xD;
           Plasma Rich Platelet.&#xD;
&#xD;
        -  Decrease the number of the re-tear rates in Rotator cuff repairs.&#xD;
&#xD;
      Overall goals: Improve long term patient function and outcomes. Increase Rotator Cuff healing&#xD;
      rates. Cost effective and time efficient method of Rotator Cuff evaluation during&#xD;
      arthroscopy.&#xD;
&#xD;
      Procedures involved (Research Interventions)&#xD;
&#xD;
      Patients undergoing a Rotator Cuff Repair:&#xD;
&#xD;
        -  Pre-operatively Questioners to be completed at pre-op American Shoulder and Elbow&#xD;
           Surgeons (ASES), University California Los Angeles (UCLA), Disabilities of the arm,&#xD;
           shoulder and hand (DASH), Short Form Health Survey-12 (SF-12) &amp; Short Form Health&#xD;
           Survey-36 (SF-36)&#xD;
&#xD;
        -  Operative Collect OR information&#xD;
&#xD;
        -  Post-operative ASES, UCLA, DASH SF-12 &amp; SF-36&#xD;
&#xD;
        -  Ultra sounds 3 months, 6 months, 1 year and 24 months&#xD;
&#xD;
      The operative intervention will proceed as current standard protocol dictates for the&#xD;
      described procedure. No changes in the operative technique will be undertaken apart from&#xD;
      injection of the dye and visualization with the camera. The idea would be to place the&#xD;
      Pinpoint probe within the subacrominal space, to check the vascular status of the tendon, and&#xD;
      then take a bite of the tendon and place the pinpoint back to check if the vascularity has&#xD;
      decreased. The Indocyanin Green dye kit will be used along with the PINPOINT system .&#xD;
      Patients with potential allergies or a history of allergies or sensitivity to sodium iodide&#xD;
      or iodinated contrast agents should not use this system, and will not be asked to&#xD;
      participate. The possible adverse reactions are, anaphylaxis, Hypotension, tachycardia,&#xD;
      dyspnea and urticarial. The duration of the procedure will be increased because of the study&#xD;
      imaging; this could be 15 to 30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Investigator requested to close, lack of equipment available.&#xD;
  </why_stopped>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">December 20, 2017</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PINPOINT System-ASES</measure>
    <time_frame>Change from baseline at 24 months</time_frame>
    <description>American Shoulder and Elbow Surgeons questionnaire this will be used for scoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PINPOINT System-UCLA</measure>
    <time_frame>Change from baseline at 24 months</time_frame>
    <description>University California Los Angeles, shoulder rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PINPOINT System-DASH</measure>
    <time_frame>Change from baseline at 24 months</time_frame>
    <description>Disabilities of the arm, shoulder and hand scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PINPOINT System-SF-36</measure>
    <time_frame>Change from baseline at 24 months</time_frame>
    <description>The short form heath survey with 36 questions to measure health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PINPOINT System-SF-12</measure>
    <time_frame>Change from baseline at 24 months</time_frame>
    <description>Short Form Health Survey with 12 questions to measure mental and physical status</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>PINPOINT system</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The operative intervention will proceed as current standard protocol dictates for the described procedure. No changes in the operative technique will be undertaken apart from injection of the dye and visualization with the camera. The idea would be to place the Pinpoint probe within the subacromial space, to check the vascular status of the tendon, and then take a bite of the tendon and place the pinpoint back to check if the vascularity has decreased. The Indocyanine Green dye kit will be used along with the PINPOINT system .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PINPOINT System</intervention_name>
    <description>To use the camera probe and identify the tendon and footprint vascularity at the time of surgery</description>
    <arm_group_label>PINPOINT system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of requiring Rotator Cuff repair surgical treatment&#xD;
&#xD;
          2. Willingness and ability to comply with the requirements of the protocol including&#xD;
             follow-up requirements.&#xD;
&#xD;
          3. Willing and able to sign a study specific informed consent form to participate.&#xD;
&#xD;
          4. Age range of ≥ 30 years old and ≤ 80 years old at time of surgery.&#xD;
&#xD;
          5. Male or female.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous Rotator cuff repair or shoulder surgery.&#xD;
&#xD;
          2. Active systemic infection or infection at the operative site.&#xD;
&#xD;
          3. Co-morbid medical conditions of the upper extremities that may affect the neurological&#xD;
             and/or pain assessment.&#xD;
&#xD;
          4. History of an osteoporotic fracture.&#xD;
&#xD;
          5. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect&#xD;
             bone and mineral metabolism.&#xD;
&#xD;
          6. Taking medications that may interfere with bony/soft tissue healing including chronic&#xD;
             steroid use.&#xD;
&#xD;
          7. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV,&#xD;
             active hepatitis B or C or fibromyalgia.&#xD;
&#xD;
          8. Insulin-dependent type 1 or type 2 diabetes.&#xD;
&#xD;
          9. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient&#xD;
             death or have an effect on outcomes prior to study completion.&#xD;
&#xD;
         10. Pregnant, or intend to become pregnant, during the course of the study.&#xD;
&#xD;
         11. Severe obesity (Body Mass Index &gt; 40).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nirav H Amin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Health, Department of Orthopaedic Surgery</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Nirav Amin, MD</investigator_full_name>
    <investigator_title>M.D. Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>


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/NCT03001050
org study id: 5160379
nct id: NCT03001050
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The overall goal of doing this study is to improve long term patient function and outcomes in
      the healing rates of Rotator Cuffs. The investigators would also like to see if this method
      can be more cost effective and time efficient for Rotator Cuff evaluation during arthroscopy.
Background or rationale for this study:

      4.5 million Patient's seek medical care for shoulder pain annually in the United States.

      250,000 patients receive rotator cuff surgery in the United States annually. Those rotator
      cuff surgeries produce a societal savings of $3.44 billion per year; averaging $13,771.00 per
      patient younger than age 61. In which case rotator cuff tears Increases with age.

      The Societal and Economic Value of Rotator Cuff Repair (AAOS) 2015 Rotator cuff repairs
      result in a lifetime societal savings in the U.S. of approximately $3.44 billion annually.
      Societal savings offset the direct costs of treatment in patients younger than age 61,
      resulting in an average net savings of $13,771 per patient. This number significantly
      increased to $77,662.00 for patients younger than 40 years of age.

      Common problem, a 55 year-old man injured his left arm. He uses a sling and has difficulties
      performing simple activities. 1 week later he falls develops immediate pain in his shoulder.
      On examination he is unable to move his left arm in any upward or sideways direction without
      supporting it with his other arm. Radiographs he brought show no signs of shoulder
      osteoarthritis, dislocation, or fracture.

      Shoulder pain is the third most common musculoskeletal reason for seeking medical care.
      Although smaller tears are less likely to propagate, larger tears tend to progress with time
      and eventually may become irreparable because of significant tendon retraction, muscle
      atrophy, or both or when the tendons tissue quality does not allow repair.

      In 1972-Neer proposed that 95% of rotator cuff injuries were caused by mechanical compression
      under the coracoacromial arch, others argued cuff tear caused spur formation.

        -  Type I-flat

        -  Type II-curved

        -  Type III-hooked

      Multifactorial:

      Extrinsic factors;

        -  Subacromial impingement

        -  Glenohumeral instability

        -  Internal impingement

        -  Trauma (acute/repetitive) Intrinsic Factors;

        -  Tendon vascular supply

        -  Collagen fiber abnormalities

      A positive painful arc test result and positive external rotation resistance test result were
      the most accurate finding for detecting Rotator Cuff Disease; whereas the presence of a
      positive lag tests (external or internal rotation) result was most accurate for diagnosis of
      a full-thickness rotator cuff tear. Differentiating a full thickness tear from a partial
      tear, the most sensitive test was the belly-press test (56.8%), and the most specific was the
      lift-off test (96.95).

      Bone microvascularization of the footprint plays a role in rotator Cuff healing. The use of
      the Pinpoint may play a pivotal role in rotator Cuff healing, en lieu of Plasma Rich
      platelets with variable results based on concentration levels.

      6 level randomized controlled trials showed no clinically significant differences in Constant
      scores, University of California, Los Angles shoulder rating (UCLA), and American Shoulder
      and Elbow Surgeons (ASES) scores between double-row and single-row rotator cuff repair.
      Overall odds ratio (OR) of intact rotator cuff tendon healing was 1.93 in patients treated
      with double-row versus single-row repair, and the difference was significant.

      A statistically significant benefit of double-row repair in the ASES and UCLA scores was
      observed in the subgroup with tears greater than 3cm. The take home point; Double row may
      improve structural healing: Clinical Relevance?

      9 studies in the meta-analysis, 5 of which were randomized prospective studies (LEVEL1).

      Double-row rotator cuff repair techniques have a significantly lower re-tear rate, higher
      ASES score and greater range of motion of internal rotation compared with single-row repair
      techniques. Point: Especially in those rotator cuff tears with a size >30mm, the double-row
      technique is recommended for repair.

      This was a Level 4 study out of the Cleveland Clinic which showed the majority of the tears
      occurred between 6 and 24 weeks. The role of a potential hand held device can assess the
      tendon quality in the office and change the rehab protocols based on tendon retraction.

      Role for study interventions:

        -  Assessing the bony vascularity at the footprint and the tendon integrity.

        -  Current standard of care:

      Steroid injection as a non-operatively treatment option. Could the steroid injections be
      affecting the tendon micro vascularization? Could using the Pinpoint assess tendon quality
      and long term healing a potential.

        -  Cystic osseous resorption and osteolysis.

        -  Breakdown products (PLLA) cause synovitis and chondrolysis.

        -  Breakdown products (PLLA) may interfere with healing-Complications of Bioabsorbable
           Suture anchors in the shoulder.

      Why Medical Row Knots?

        -  Enhances Biology be sealing footprint from synovial fluid.

        -  Compared to knotless medical row, better biomechanics incl. load to failure, stiffness,
           less gap formation.

        -  A biomechanical comparison of 2 technical of double-row rotator cuff fixation: the
           importance of medical row knots.

      Clinical Implications and Surgeon's Role;

        -  Choice of a tissue-penetrating instrument; smaller penetrating devices resulting in
           improves characteristics of stitch holding strength.

        -  Size of the tissue bite; bigger bite size being stronger.

        -  Most critical variable under a surgeons control during a rotator cuff repair is the
           choice of the stitch.

      Role for Pinpoint:

      In the re-tear and partial-repair groups, postoperative tendon preservation at the middle
      fact significantly affected the Japanese Orthopaedic Assocation (JOA) and UCLA scores
      (P=.014, respectively). Considering the patients with tendon healing had better clinical
      factors, the Pinpoint may help identify the tendon and footprint vascularity at time of
      surgery.

      Goals for the Pinpoint:

      To attempt to show that increased vascularity may have an effect of the muscle quality,
      therefore improving the strength and function long term.

      Objective:

        -  This prospective study aims to obtain the accurate level within a range of a 95% CI
           imaging Rotator Cuff tendons and the footprint.

        -  Ensure the Vascularity of the tendon after the footprint and the tendon have been
           restored to the anatomic footprint. See if the level of the Rotator Cuff bite affects
           the vascular flow of the tendon.

        -  Does tying the medical row or excessive tension change the vascularity of the Rotator
           Cuff.

        -  We would like to see if by using the Pinpoint system it may be more cost effective then
           Plasma Rich Platelet.

        -  Decrease the number of the re-tear rates in Rotator cuff repairs.

      Overall goals: Improve long term patient function and outcomes. Increase Rotator Cuff healing
      rates. Cost effective and time efficient method of Rotator Cuff evaluation during
      arthroscopy.

      Procedures involved (Research Interventions)

      Patients undergoing a Rotator Cuff Repair:

        -  Pre-operatively Questioners to be completed at pre-op American Shoulder and Elbow
           Surgeons (ASES), University California Los Angeles (UCLA), Disabilities of the arm,
           shoulder and hand (DASH), Short Form Health Survey-12 (SF-12) & Short Form Health
           Survey-36 (SF-36)

        -  Operative Collect OR information

        -  Post-operative ASES, UCLA, DASH SF-12 & SF-36

        -  Ultra sounds 3 months, 6 months, 1 year and 24 months

      The operative intervention will proceed as current standard protocol dictates for the
      described procedure. No changes in the operative technique will be undertaken apart from
      injection of the dye and visualization with the camera. The idea would be to place the
      Pinpoint probe within the subacrominal space, to check the vascular status of the tendon, and
      then take a bite of the tendon and place the pinpoint back to check if the vascularity has
      decreased. The Indocyanin Green dye kit will be used along with the PINPOINT system .
      Patients with potential allergies or a history of allergies or sensitivity to sodium iodide
      or iodinated contrast agents should not use this system, and will not be asked to
      participate. The possible adverse reactions are, anaphylaxis, Hypotension, tachycardia,
      dyspnea and urticarial. The duration of the procedure will be increased because of the study
      imaging; this could be 15 to 30 minutes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: PINPOINT System-ASES
time frame: Change from baseline at 24 months
description: American Shoulder and Elbow Surgeons questionnaire this will be used for scoring
measure: PINPOINT System-UCLA
time frame: Change from baseline at 24 months
description: University California Los Angeles, shoulder rating scale
measure: PINPOINT System-DASH
time frame: Change from baseline at 24 months
description: Disabilities of the arm, shoulder and hand scores
measure: PINPOINT System-SF-36
time frame: Change from baseline at 24 months
description: The short form heath survey with 36 questions to measure health status
measure: PINPOINT System-SF-12
time frame: Change from baseline at 24 months
description: Short Form Health Survey with 12 questions to measure mental and physical status
arm group label: PINPOINT system
arm group type: Other
description: The operative intervention will proceed as current standard protocol dictates for the described procedure. No changes in the operative technique will be undertaken apart from injection of the dye and visualization with the camera. The idea would be to place the Pinpoint probe within the subacromial space, to check the vascular status of the tendon, and then take a bite of the tendon and place the pinpoint back to check if the vascularity has decreased. The Indocyanine Green dye kit will be used along with the PINPOINT system .
intervention type: Device
intervention name: PINPOINT System
description: To use the camera probe and identify the tendon and footprint vascularity at the time of surgery
arm group label: PINPOINT system
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nirav H Amin, MD
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Loma Linda University
investigator full name: Nirav Amin, MD
investigator title: M.D. Associate Professor
mesh term: Rotator Cuff Injuries
sharing ipd: No