<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/NCT04444076</url>
  </required_header>
  <id_info>
    <org_study_id>MALLAMANGUITO</org_study_id>
    <nct_id>NCT04444076</nct_id>
  </id_info>
  <brief_title>Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair.</brief_title>
  <acronym>MALLAMANGUITO</acronym>
  <official_title>Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</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>
      This study aims a determine the effect that the addition of REGENETEN Bioinductive Implant&#xD;
      has on Supraspinatus Tendon Repair. 120 patients will be included in this prospective,&#xD;
      randomized, parallel group study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rotator cuff tear is one of the most frequent pathologies in the shoulder joint. When&#xD;
      there are many symptoms these breaks are repaired surgically. The success rate of healing of&#xD;
      these injuries is between 30% and 80%. In two recent studies conducted at two of the centers&#xD;
      participating in this trial, the success rate of repair was 75% (unpublished data) and 70%&#xD;
      respectively.&#xD;
&#xD;
      The use of high porosity resorbable bovine collagen meshes as bioinductive scaffolds for cuff&#xD;
      repair seems to be a valid alternative when trying to improve the success rate in the healing&#xD;
      of rotator cuff injuries.&#xD;
&#xD;
      REGENETEN Bioinductive Implant (a high porosity reconstituted type I collagen mesh of bovine&#xD;
      origin) is applied to the repaired tendon. In a pilot study of 9 subjects with full thickness&#xD;
      supraspinatus ruptures who underwent tendon repair and subsequently had the implant&#xD;
      associated with the rupture, a significant clinical improvement was observed after one year&#xD;
      and was observed on magnetic resonance imaging ( RM) 100% healing of breaks. In a study of 33&#xD;
      subjects with partial thickness tears treated with the implant alone, improvement in MRI&#xD;
      characteristics of the tendon was observed in 31 cases. There is a study that performs a&#xD;
      histological analysis of samples obtained in 7 subjects in whom the implant was used. No&#xD;
      evidence of foreign body reaction or inflammatory reaction was observed. In none of the three&#xD;
      studies where said implant was used in humans were any complications or adverse effects&#xD;
      related to the use of said implant observed.&#xD;
&#xD;
      The objective of the study is to evaluate the effect that the addition of REGENETEN bovine&#xD;
      collagen mesh has on tendon repair on MRI performed one year after surgery.&#xD;
&#xD;
      The study does not in itself pose a greater risk than the usual practice for the patient,&#xD;
      since in these subjects where the implant could be used as a supplement to the repair, having&#xD;
      already obtained the CE marking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">February 2026</completion_date>
  <primary_completion_date type="Anticipated">February 2026</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Integrity of the tendon repaired in an MRI study one year after the intervention using the Sugaya classification (Sugaya H (2005)).</measure>
    <time_frame>12 months</time_frame>
    <description>This is a classification system described by Sugaya et al. which uses magnetic resonance imaging in order to evaluate tendon integrity after rotator cuff repair. Postoperative cuff integrity is classified into 5 categories: type I, sufficient thickness with homogenously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, presence of minor discontinuity; type V, presence of major discontinuity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain levels. Measured with questions 3 to 6 of the Brief Pain Inventory.</measure>
    <time_frame>3 months, 6 months and 12 months after surgery</time_frame>
    <description>This item has a scale of 0 to 10 with 0 indicating &quot;No pain&quot; and 10 indicating &quot;Pain as bad as you can imagine&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional changes, measured with the Constant-Murley Scale.</measure>
    <time_frame>3 months, 6 months and 12 months after surgery.</time_frame>
    <description>The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional changes, measured with ASES questionnaire.</measure>
    <time_frame>3 months, 6 months and 12 months after surgery.</time_frame>
    <description>The American Shoulder and Elbow Surgeons (ASES) questionnaire was developed to provide a standardized method for evaluating shoulder function and has been validated in patients with any array of shoulder pathologies. The range is from 0 to 100, with 0 being worst, and 100 being best.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life measured with EQ-5D-5L questionnaire.</measure>
    <time_frame>3 months, 6 months and 12 months after surgery.</time_frame>
    <description>The Euro Quality of Life Five Dimensions 5 Level (EQ-5D-5L) questionnaire consists of two parts: a descriptive system and a Visual Analogue Scale.&#xD;
The descriptive system describes the health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients who reported problems were then categorized into two categories, a &quot;has no problem&quot; category (health state code of 1) and &quot;has problem&quot; category (health state code of 2-5) for each level of each dimension.&#xD;
The second part of the EQ-5D-5L questionnaire is the EQ-VAS, which is a thermometer-like scale (ranging from 0 to 100) that reflects the patient's health in general. EQ-VAS represents the patient perspective, where 0 indicates the worst imaginable health state and 100 reflects the best imaginable health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with complications in both arms</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of complications, including: infection, implant intolerance, readmission, reoperation, or fracture.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Supraspinatus Tear</condition>
  <arm_group>
    <arm_group_label>REGENETEN Bioinductive Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>REGENETEN bioinductive Implant,a bovine mesh that will be implanted following supraspinatus tendon repair.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Supraspinatus tendon repair.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>REGENETEN Bioinductive Implant</intervention_name>
    <description>REGENETEN bioinductive Implant,a reconstituted bovine origin type I collagen mesh with a proprietary high porosity system that is commercialized sterile, dehydrated and desiccated in two sizes (20x26mm and 25x31mm). It will be implanted following supraspinatus tendon repair.</description>
    <arm_group_label>REGENETEN Bioinductive Implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who, after having received information about the design, the purposes of the&#xD;
             study, the possible risks that may arise from it, and who may at any time deny their&#xD;
             collaboration, give their written consent to participate in the study.&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
          -  Patients who present:&#xD;
&#xD;
               -  Symptomatic ruptures of the supraspinatus muscle (SE) with or without involvement&#xD;
                  of the infraspinatus (IE) with anteroposterior size of the rupture of 1 to 4 cm.&#xD;
&#xD;
               -  With less than 3cm of retraction,&#xD;
&#xD;
               -  With the absence of severe muscular atrophy confirmed by magnetic resonance&#xD;
                  imaging or CT (Absence of Goutalier grade I or II atrophy in muscle mass). MRI or&#xD;
                  CT must have been performed at most 6 months before the intervention.&#xD;
&#xD;
               -  That it be confirmed during the exploratory arthroscopy at the beginning of the&#xD;
                  intervention.&#xD;
&#xD;
               -  That after repair a coverage of the native footprint of the tendon of at least&#xD;
                  80% is obtained&#xD;
&#xD;
          -  No presence of rupture that requires repair in the tendons of the subscapularis&#xD;
             muscles or minor round&#xD;
&#xD;
          -  Understand the purpose of the study and be available for regular hospital visits.&#xD;
&#xD;
          -  Negative urine pregnancy test performed in the 7 days prior to the start of study&#xD;
             treatment in premenopausal women or &lt;2 years after menopause&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or planning to become pregnant during the course of the study.&#xD;
&#xD;
          -  SE tendon tears of more than 3cm retraction&#xD;
&#xD;
          -  Tendon ruptures of the SE and IE muscles with anteroposterior size of the rupture&#xD;
             greater than 4 cm.&#xD;
&#xD;
          -  SE and / or IE tendon ruptures that are considered irreparable or only partially&#xD;
             repairable at the time of the intervention&#xD;
&#xD;
          -  Presence of ruptures of the subscapularis and / or minor round tendons&#xD;
&#xD;
          -  Presence of grade III or IV Goutallier atrophy in the supraspinatus muscle mass&#xD;
&#xD;
          -  History of other orthopedic pathologies in the affected shoulder (previous shoulder&#xD;
             surgeries, fractures, tendon re-ruptures of the supraspinatus or other tendons,&#xD;
             rheumatic diseases, septic arthritis, ...)&#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>Miguel Angel Ruiz Iban, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Ramón y Cajal, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Supraspinatus Tear</keyword>
  <keyword>REGENETEN</keyword>
  <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/NCT04444076
org study id: MALLAMANGUITO
nct id: NCT04444076
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims a determine the effect that the addition of REGENETEN Bioinductive Implant
      has on Supraspinatus Tendon Repair. 120 patients will be included in this prospective,
      randomized, parallel group study.
The rotator cuff tear is one of the most frequent pathologies in the shoulder joint. When
      there are many symptoms these breaks are repaired surgically. The success rate of healing of
      these injuries is between 30% and 80%. In two recent studies conducted at two of the centers
      participating in this trial, the success rate of repair was 75% (unpublished data) and 70%
      respectively.

      The use of high porosity resorbable bovine collagen meshes as bioinductive scaffolds for cuff
      repair seems to be a valid alternative when trying to improve the success rate in the healing
      of rotator cuff injuries.

      REGENETEN Bioinductive Implant (a high porosity reconstituted type I collagen mesh of bovine
      origin) is applied to the repaired tendon. In a pilot study of 9 subjects with full thickness
      supraspinatus ruptures who underwent tendon repair and subsequently had the implant
      associated with the rupture, a significant clinical improvement was observed after one year
      and was observed on magnetic resonance imaging ( RM) 100% healing of breaks. In a study of 33
      subjects with partial thickness tears treated with the implant alone, improvement in MRI
      characteristics of the tendon was observed in 31 cases. There is a study that performs a
      histological analysis of samples obtained in 7 subjects in whom the implant was used. No
      evidence of foreign body reaction or inflammatory reaction was observed. In none of the three
      studies where said implant was used in humans were any complications or adverse effects
      related to the use of said implant observed.

      The objective of the study is to evaluate the effect that the addition of REGENETEN bovine
      collagen mesh has on tendon repair on MRI performed one year after surgery.

      The study does not in itself pose a greater risk than the usual practice for the patient,
      since in these subjects where the implant could be used as a supplement to the repair, having
      already obtained the CE marking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Integrity of the tendon repaired in an MRI study one year after the intervention using the Sugaya classification (Sugaya H (2005)).
time frame: 12 months
description: This is a classification system described by Sugaya et al. which uses magnetic resonance imaging in order to evaluate tendon integrity after rotator cuff repair. Postoperative cuff integrity is classified into 5 categories: type I, sufficient thickness with homogenously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, presence of minor discontinuity; type V, presence of major discontinuity
measure: Change in pain levels. Measured with questions 3 to 6 of the Brief Pain Inventory.
time frame: 3 months, 6 months and 12 months after surgery
description: This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine"
measure: Functional changes, measured with the Constant-Murley Scale.
time frame: 3 months, 6 months and 12 months after surgery.
description: The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.
measure: Functional changes, measured with ASES questionnaire.
time frame: 3 months, 6 months and 12 months after surgery.
description: The American Shoulder and Elbow Surgeons (ASES) questionnaire was developed to provide a standardized method for evaluating shoulder function and has been validated in patients with any array of shoulder pathologies. The range is from 0 to 100, with 0 being worst, and 100 being best.
measure: Changes in quality of life measured with EQ-5D-5L questionnaire.
time frame: 3 months, 6 months and 12 months after surgery.
description: The Euro Quality of Life Five Dimensions 5 Level (EQ-5D-5L) questionnaire consists of two parts: a descriptive system and a Visual Analogue Scale.
The descriptive system describes the health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients who reported problems were then categorized into two categories, a "has no problem" category (health state code of 1) and "has problem" category (health state code of 2-5) for each level of each dimension.
The second part of the EQ-5D-5L questionnaire is the EQ-VAS, which is a thermometer-like scale (ranging from 0 to 100) that reflects the patient's health in general. EQ-VAS represents the patient perspective, where 0 indicates the worst imaginable health state and 100 reflects the best imaginable health state.
measure: Number of patients with complications in both arms
time frame: 12 months
description: Rate of complications, including: infection, implant intolerance, readmission, reoperation, or fracture.
arm group label: REGENETEN Bioinductive Implant
arm group type: Experimental
description: REGENETEN bioinductive Implant,a bovine mesh that will be implanted following supraspinatus tendon repair.
arm group label: Standard of Care
arm group type: No Intervention
description: Supraspinatus tendon repair.
intervention type: Device
intervention name: REGENETEN Bioinductive Implant
description: REGENETEN bioinductive Implant,a reconstituted bovine origin type I collagen mesh with a proprietary high porosity system that is commercialized sterile, dehydrated and desiccated in two sizes (20x26mm and 25x31mm). It will be implanted following supraspinatus tendon repair.
arm group label: REGENETEN Bioinductive Implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Miguel Angel Ruiz Iban, MD, PhD
role: Principal Investigator
affiliation: Hospital Ramón y Cajal, Spain
facility: 
country: Spain
responsible party type: Sponsor
sharing ipd: No