<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/NCT04421417</url>
  </required_header>
  <id_info>
    <org_study_id>2019-78167</org_study_id>
    <nct_id>NCT04421417</nct_id>
  </id_info>
  <brief_title>The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing</brief_title>
  <official_title>Early-term Effects of Microfracture on Tendon Vascularity and Healing in Arthroscopic Treatment of Chronic Rotator Cuff Tears: A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göker Utku değer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University - Cerrahpasa (IUC)</source>
  <oversight_info>
    <has_dmc>No</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>
      Patients with complaints of shoulder pain or limitation of motion and had rotator cuff&#xD;
      rupture diagnosed with magnetic resonance imaging will be analyzed and the patients with&#xD;
      surgical indication will be included in a randomized fashion. One group of patient will&#xD;
      undergo standard arthroscopic rotator cuff repair, while the other group will have&#xD;
      microfracture procedure in addition to the standard arthroscopic repair. Before the&#xD;
      operation, functional and clinical conditions will be recorded with Constant and American&#xD;
      Shoulder and Elbow Surgeons Shoulder Score (ASES) universal shoulder scoring systems and&#xD;
      Visual Analogue Scale(VAS) pain scale. The blood supply and healing of the tendon in the&#xD;
      repair area will be compared by the doppler ultrasound (superb microvascular imaging) at the&#xD;
      2nd, 4th, 8th and 12th week after the operation. Post-operative clinical, functional status&#xD;
      and pain levels will be evaluated with Constant, ASES and VAS pain scales at 24th week.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Study was stopped due to COVID-19 related issues. Collected data could be present as pilot&#xD;
    trial.&#xD;
  </why_stopped>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2022</completion_date>
  <primary_completion_date type="Actual">September 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>assessing early change of tendon and footprint area vascularity</measure>
    <time_frame>4th week</time_frame>
    <description>we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>assessing early change of tendon and footprint area vascularity</measure>
    <time_frame>8th week</time_frame>
    <description>we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>assessing early change of tendon and footprint area vascularity</measure>
    <time_frame>12th week</time_frame>
    <description>we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>functional outcome</measure>
    <time_frame>24th week</time_frame>
    <description>This entity will be asses by functional scoring systems.These are American Shoulder and Elbow Surgeons Shoulder Score (ASES) and Constant Shoulder Score. The ASES is a composite instrument, requiring both a physician assessment and a patient-completed portion; however, it is commonly presented as solely the patient-reported survey. This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. Constant Score was designed to assess the functional state of a normal, a diseased, or a treated shoulder.The Constant score contains both physician-completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rotator Cuff Tears</condition>
  <condition>Micro Fracture</condition>
  <arm_group>
    <arm_group_label>Standard Arthroscopic Rotator Cuff Repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Microfracture and Arthroscopic Rotator Cuff Repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microfracture + Standard Arthroscopic Rotator Cuff Repair</intervention_name>
    <description>drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair</description>
    <arm_group_label>Microfracture and Arthroscopic Rotator Cuff Repair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Arthroscopic Rotator Cuff Repair</intervention_name>
    <description>Standard Arthroscopic Rotator Cuff Repair</description>
    <arm_group_label>Standard Arthroscopic Rotator Cuff Repair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  degenerative rotator cuff tears&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  traumatic rotator cuff tears&#xD;
&#xD;
          -  rheumatoid diseases&#xD;
&#xD;
          -  previous surgery of rotator cuff tendon&#xD;
&#xD;
          -  glenohumeral arthritis&#xD;
&#xD;
          -  acromioclavicular arthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. doi: 10.1177/0363546512442924. Epub 2012 Apr 10.</citation>
    <PMID>22495146</PMID>
  </reference>
  <reference>
    <citation>Zumstein MA, Rumian A, Lesbats V, Schaer M, Boileau P. Increased vascularization during early healing after biologic augmentation in repair of chronic rotator cuff tears using autologous leukocyte- and platelet-rich fibrin (L-PRF): a prospective randomized controlled pilot trial. J Shoulder Elbow Surg. 2014 Jan;23(1):3-12. doi: 10.1016/j.jse.2013.08.017.</citation>
    <PMID>24331121</PMID>
  </reference>
  <reference>
    <citation>Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.</citation>
    <PMID>23522987</PMID>
  </reference>
  <reference>
    <citation>Osti L, Del Buono A, Maffulli N. Microfractures at the rotator cuff footprint: a randomised controlled study. Int Orthop. 2013 Nov;37(11):2165-71. doi: 10.1007/s00264-013-1952-z. Epub 2013 Jun 13.</citation>
    <PMID>23760681</PMID>
  </reference>
  <reference>
    <citation>Bilsel K, Yildiz F, Kapicioglu M, Uzer G, Elmadag M, Pulatkan A, Esrefoglu M, Bozdag E, Milano G. Efficacy of bone marrow-stimulating technique in rotator cuff repair. J Shoulder Elbow Surg. 2017 Aug;26(8):1360-1366. doi: 10.1016/j.jse.2017.02.014. Epub 2017 Apr 7.</citation>
    <PMID>28395947</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 16, 2021</last_update_submitted>
  <last_update_submitted_qc>November 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
    <investigator_full_name>Göker Utku değer</investigator_full_name>
    <investigator_title>Research assistant</investigator_title>
  </responsible_party>
  <keyword>Superb microvascular imaging</keyword>
  <keyword>Rotator Cuff Tears</keyword>
  <keyword>Micro Fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
    <mesh_term>Fractures, Stress</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/NCT04421417
org study id: 2019-78167
nct id: NCT04421417
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with complaints of shoulder pain or limitation of motion and had rotator cuff
      rupture diagnosed with magnetic resonance imaging will be analyzed and the patients with
      surgical indication will be included in a randomized fashion. One group of patient will
      undergo standard arthroscopic rotator cuff repair, while the other group will have
      microfracture procedure in addition to the standard arthroscopic repair. Before the
      operation, functional and clinical conditions will be recorded with Constant and American
      Shoulder and Elbow Surgeons Shoulder Score (ASES) universal shoulder scoring systems and
      Visual Analogue Scale(VAS) pain scale. The blood supply and healing of the tendon in the
      repair area will be compared by the doppler ultrasound (superb microvascular imaging) at the
      2nd, 4th, 8th and 12th week after the operation. Post-operative clinical, functional status
      and pain levels will be evaluated with Constant, ASES and VAS pain scales at 24th week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: assessing early change of tendon and footprint area vascularity
time frame: 4th week
description: we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
measure: assessing early change of tendon and footprint area vascularity
time frame: 8th week
description: we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
measure: assessing early change of tendon and footprint area vascularity
time frame: 12th week
description: we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
measure: functional outcome
time frame: 24th week
description: This entity will be asses by functional scoring systems.These are American Shoulder and Elbow Surgeons Shoulder Score (ASES) and Constant Shoulder Score. The ASES is a composite instrument, requiring both a physician assessment and a patient-completed portion; however, it is commonly presented as solely the patient-reported survey. This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. Constant Score was designed to assess the functional state of a normal, a diseased, or a treated shoulder.The Constant score contains both physician-completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).
arm group label: Standard Arthroscopic Rotator Cuff Repair
arm group type: Active Comparator
arm group label: Microfracture and Arthroscopic Rotator Cuff Repair
arm group type: Experimental
intervention type: Procedure
intervention name: Microfracture + Standard Arthroscopic Rotator Cuff Repair
description: drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair
arm group label: Microfracture and Arthroscopic Rotator Cuff Repair
intervention type: Procedure
intervention name: Standard Arthroscopic Rotator Cuff Repair
description: Standard Arthroscopic Rotator Cuff Repair
arm group label: Standard Arthroscopic Rotator Cuff Repair
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. doi: 10.1177/0363546512442924. Epub 2012 Apr 10.
PMID: 22495146
citation: Zumstein MA, Rumian A, Lesbats V, Schaer M, Boileau P. Increased vascularization during early healing after biologic augmentation in repair of chronic rotator cuff tears using autologous leukocyte- and platelet-rich fibrin (L-PRF): a prospective randomized controlled pilot trial. J Shoulder Elbow Surg. 2014 Jan;23(1):3-12. doi: 10.1016/j.jse.2013.08.017.
PMID: 24331121
citation: Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.
PMID: 23522987
citation: Osti L, Del Buono A, Maffulli N. Microfractures at the rotator cuff footprint: a randomised controlled study. Int Orthop. 2013 Nov;37(11):2165-71. doi: 10.1007/s00264-013-1952-z. Epub 2013 Jun 13.
PMID: 23760681
citation: Bilsel K, Yildiz F, Kapicioglu M, Uzer G, Elmadag M, Pulatkan A, Esrefoglu M, Bozdag E, Milano G. Efficacy of bone marrow-stimulating technique in rotator cuff repair. J Shoulder Elbow Surg. 2017 Aug;26(8):1360-1366. doi: 10.1016/j.jse.2017.02.014. Epub 2017 Apr 7.
PMID: 28395947
responsible party type: Sponsor-Investigator
investigator affiliation: Istanbul University - Cerrahpasa (IUC)
investigator full name: Göker Utku değer
investigator title: Research assistant
mesh term: Rotator Cuff Injuries
mesh term: Fractures, Stress
sharing ipd: No