<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/NCT01687777</url>
  </required_header>
  <id_info>
    <org_study_id>EC07/90208</org_study_id>
    <secondary_id>2007-007630-19</secondary_id>
    <nct_id>NCT01687777</nct_id>
  </id_info>
  <brief_title>Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair</brief_title>
  <acronym>msctendonrep</acronym>
  <official_title>Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital San Carlos, Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical reconstructive procedures for rotator cuff tears present a number of limitations.&#xD;
      The few studies in which the repair integrity is evaluated, have shown the existence of a&#xD;
      high rate of reruptures in spite of the fact that the functional results obtained short-term&#xD;
      are satisfactory. Morphologic analysis from the sutures, after different follow-up periods,&#xD;
      has not shown satisfactory results.&#xD;
&#xD;
      Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells&#xD;
      (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the&#xD;
      function compared to cell-free tendon defect treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will include: Patients with massive tears from the supraspinatus tendon, in&#xD;
      which reconstructive surgery is indicated. Patients will be randomly stratified into two&#xD;
      groups.&#xD;
&#xD;
      The first group will receive autologous MSCs transplantation included in a collagen type I&#xD;
      membrane (OrthADAPT) and the second group will serve as cell-free controls.&#xD;
&#xD;
      The surgical procedure will be performed by arthroscopic and/or combined technique:&#xD;
      arthroscopic subacromial decompression and mini-open rotator cuff repair. The OrthADAPT-cells&#xD;
      composite will be put on the sutured area. The radiograms and function will be assessed by&#xD;
      independently observers, who will no have knowledge of the study group from which they will&#xD;
      have been obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2010</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</primary_completion_date>
  <phase>Phase 2</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>Constant Shoulder Score</measure>
    <time_frame>up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nuclear Magnetic Resonance (RMN)</measure>
    <time_frame>6 months, one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>Mesenchymal stem cells (MSCs)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OrthADAPT</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Membrane of collagen type I (OrthoADAPT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Mesenchymal Stem Cells (MSCs)</intervention_name>
    <description>20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.</description>
    <arm_group_label>Mesenchymal stem cells (MSCs)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>OrthADAPT</intervention_name>
    <arm_group_label>OrthADAPT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject providing informed consent.&#xD;
&#xD;
          -  Comprised subject male/female aged 55-80.&#xD;
&#xD;
          -  Subject has a supraspinatus tendon rupture.&#xD;
&#xD;
          -  Subject has an unilateral injury.&#xD;
&#xD;
          -  Rupture is enough to need medical assistance.&#xD;
&#xD;
          -  Subject has an conventional medical treatment fail at least 3 months.&#xD;
&#xD;
          -  Subject has a &quot;reparable&quot; injury according to Goutallier´s criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a prior clinical history of arthritis, diabetes or inflammatory disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Fernandez-Gutierrez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Clinico San Carlos</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pilar Tornero-Esteban, Bs, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario Clinico San Carlos</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benjamín Fernández-Gutiérrez, PhD</last_name>
    <phone>+34913303615</phone>
    <phone_ext>7803</phone_ext>
    <email>bfernandez.hcsc@salud.madrid.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pilar Tornero-Esteban, PhD</last_name>
    <phone>+34913303615</phone>
    <phone_ext>7434</phone_ext>
    <email>mptornero@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitario Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Fernandez-Gutierrez, MD, PhD</last_name>
      <phone>+34913303615</phone>
      <phone_ext>7803</phone_ext>
      <email>bfernandez.hcsc@salud.madrid.org</email>
    </contact>
    <contact_backup>
      <last_name>Pilar Tornero-Esteban, Bs, PhD</last_name>
      <phone>+34913303615</phone>
      <phone_ext>7434</phone_ext>
      <email>mptornero@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Fernandez-Gutierrez, MD, PhD</last_name>
      <phone>+34913303615</phone>
      <phone_ext>7803</phone_ext>
      <email>bfernandez.hcsc@salud.madrid.org</email>
    </contact>
    <contact_backup>
      <last_name>Pilar Tornero-Esteban, Bs,PhD</last_name>
      <phone>+34913303615</phone>
      <phone_ext>7434</phone_ext>
      <email>mptornero@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Awad HA, Butler DL, Boivin GP, Smith FN, Malaviya P, Huibregtse B, Caplan AI. Autologous mesenchymal stem cell-mediated repair of tendon. Tissue Eng. 1999 Jun;5(3):267-77. doi: 10.1089/ten.1999.5.267.</citation>
    <PMID>10434073</PMID>
  </reference>
  <reference>
    <citation>Awad HA, Boivin GP, Dressler MR, Smith FN, Young RG, Butler DL. Repair of patellar tendon injuries using a cell-collagen composite. J Orthop Res. 2003 May;21(3):420-31. doi: 10.1016/S0736-0266(02)00163-8.</citation>
    <PMID>12706014</PMID>
  </reference>
  <reference>
    <citation>Barber FA, Aziz-Jacobo J. Biomechanical testing of commercially available soft-tissue augmentation materials. Arthroscopy. 2009 Nov;25(11):1233-9. doi: 10.1016/j.arthro.2009.05.012. Epub 2009 Oct 2.</citation>
    <PMID>19896044</PMID>
  </reference>
  <reference>
    <citation>Bruder SP, Jaiswal N, Haynesworth SE. Growth kinetics, self-renewal, and the osteogenic potential of purified human mesenchymal stem cells during extensive subcultivation and following cryopreservation. J Cell Biochem. 1997 Feb;64(2):278-94. doi: 10.1002/(sici)1097-4644(199702)64:23.0.co;2-f.</citation>
    <PMID>9027588</PMID>
  </reference>
  <reference>
    <citation>Bruder SP, Kraus KH, Goldberg VM, Kadiyala S. The effect of implants loaded with autologous mesenchymal stem cells on the healing of canine segmental bone defects. J Bone Joint Surg Am. 1998 Jul;80(7):985-96. doi: 10.2106/00004623-199807000-00007.</citation>
    <PMID>9698003</PMID>
  </reference>
  <reference>
    <citation>Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.</citation>
    <PMID>1870029</PMID>
  </reference>
  <reference>
    <citation>Caplan AI. The mesengenic process. Clin Plast Surg. 1994 Jul;21(3):429-35.</citation>
    <PMID>7924141</PMID>
  </reference>
  <reference>
    <citation>Caplan AI. Review: mesenchymal stem cells: cell-based reconstructive therapy in orthopedics. Tissue Eng. 2005 Jul-Aug;11(7-8):1198-211. doi: 10.1089/ten.2005.11.1198.</citation>
    <PMID>16144456</PMID>
  </reference>
  <reference>
    <citation>Cofield RH, Parvizi J, Hoffmeyer PJ, Lanzer WL, Ilstrup DM, Rowland CM. Surgical repair of chronic rotator cuff tears. A prospective long-term study. J Bone Joint Surg Am. 2001 Jan;83(1):71-7. doi: 10.2106/00004623-200101000-00010.</citation>
    <PMID>11205861</PMID>
  </reference>
  <reference>
    <citation>Djurasovic M, Marra G, Arroyo JS, Pollock RG, Flatow EL, Bigliani LU. Revision rotator cuff repair: factors influencing results. J Bone Joint Surg Am. 2001 Dec;83(12):1849-55. doi: 10.2106/00004623-200112000-00013.</citation>
    <PMID>11741065</PMID>
  </reference>
  <reference>
    <citation>Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.</citation>
    <PMID>14960664</PMID>
  </reference>
  <reference>
    <citation>Gimbel JA, Van Kleunen JP, Lake SP, Williams GR, Soslowsky LJ. The role of repair tension on tendon to bone healing in an animal model of chronic rotator cuff tears. J Biomech. 2007;40(3):561-8. doi: 10.1016/j.jbiomech.2006.02.010. Epub 2006 Apr 4.</citation>
    <PMID>16600252</PMID>
  </reference>
  <reference>
    <citation>Goutallier D, Postel JM, Gleyze P, Leguilloux P, Van Driessche S. Influence of cuff muscle fatty degeneration on anatomic and functional outcomes after simple suture of full-thickness tears. J Shoulder Elbow Surg. 2003 Nov-Dec;12(6):550-4. doi: 10.1016/s1058-2746(03)00211-8.</citation>
    <PMID>14671517</PMID>
  </reference>
  <reference>
    <citation>Harryman DT 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen FA 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am. 1991 Aug;73(7):982-9.</citation>
    <PMID>1874784</PMID>
  </reference>
  <reference>
    <citation>Jaiswal N, Haynesworth SE, Caplan AI, Bruder SP. Osteogenic differentiation of purified, culture-expanded human mesenchymal stem cells in vitro. J Cell Biochem. 1997 Feb;64(2):295-312.</citation>
    <PMID>9027589</PMID>
  </reference>
  <reference>
    <citation>Johnson W, Inamasu J, Yantzer B, Papangelou C, Guiot B. Comparative in vitro biomechanical evaluation of two soft tissue defect products. J Biomed Mater Res B Appl Biomater. 2007 Apr 5. doi: 10.1002/jbm.b.30816. Online ahead of print.</citation>
    <PMID>17415772</PMID>
  </reference>
  <reference>
    <citation>Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am. 2000 Mar;82(3):304-14. doi: 10.2106/00004623-200003000-00002.</citation>
    <PMID>10724223</PMID>
  </reference>
  <reference>
    <citation>Mansilla E, Marin GH, Sturla F, Drago HE, Gil MA, Salas E, Gardiner MC, Piccinelli G, Bossi S, Salas E, Petrelli L, Iorio G, Ramos CA, Soratti C. Human mesenchymal stem cells are tolerized by mice and improve skin and spinal cord injuries. Transplant Proc. 2005 Jan-Feb;37(1):292-4. doi: 10.1016/j.transproceed.2005.01.070.</citation>
    <PMID>15808623</PMID>
  </reference>
  <reference>
    <citation>Pillow RP, Epstein RB, Buckner CD, Giblett ER, Thomas ED. Treatment of bone-marrow failure by isogeneic marrow infusion. N Engl J Med. 1966 Jul 14;275(2):94-7. doi: 10.1056/NEJM196607142750209. No abstract available.</citation>
    <PMID>5327813</PMID>
  </reference>
  <reference>
    <citation>Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. doi: 10.1126/science.284.5411.143.</citation>
    <PMID>10102814</PMID>
  </reference>
  <reference>
    <citation>Prickett WD, Teefey SA, Galatz LM, Calfee RP, Middleton WD, Yamaguchi K. Accuracy of ultrasound imaging of the rotator cuff in shoulders that are painful postoperatively. J Bone Joint Surg Am. 2003 Jun;85(6):1084-9. doi: 10.2106/00004623-200306000-00016.</citation>
    <PMID>12784007</PMID>
  </reference>
  <reference>
    <citation>Saito T, Dennis JE, Lennon DP, Young RG, Caplan AI. Myogenic Expression of Mesenchymal Stem Cells within Myotubes of mdx Mice in Vitro and in Vivo. Tissue Eng. 1995 Winter;1(4):327-43. doi: 10.1089/ten.1995.1.327.</citation>
    <PMID>19877897</PMID>
  </reference>
  <reference>
    <citation>Romeo AA, Hang DW, Bach BR Jr, Shott S. Repair of full thickness rotator cuff tears. Gender, age, and other factors affecting outcome. Clin Orthop Relat Res. 1999 Oct;(367):243-55.</citation>
    <PMID>10546622</PMID>
  </reference>
  <reference>
    <citation>Smith RK, Korda M, Blunn GW, Goodship AE. Isolation and implantation of autologous equine mesenchymal stem cells from bone marrow into the superficial digital flexor tendon as a potential novel treatment. Equine Vet J. 2003 Jan;35(1):99-102. doi: 10.2746/042516403775467388. No abstract available.</citation>
    <PMID>12553472</PMID>
  </reference>
  <reference>
    <citation>Wakitani S, Goto T, Pineda SJ, Young RG, Mansour JM, Caplan AI, Goldberg VM. Mesenchymal cell-based repair of large, full-thickness defects of articular cartilage. J Bone Joint Surg Am. 1994 Apr;76(4):579-92. doi: 10.2106/00004623-199404000-00013.</citation>
    <PMID>8150826</PMID>
  </reference>
  <reference>
    <citation>Yamaguchi K, Levine WN, Marra G, Galatz LM, Klepps S, Flatow EL. Transitioning to arthroscopic rotator cuff repair: the pros and cons. Instr Course Lect. 2003;52:81-92.</citation>
    <PMID>12690842</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
    <investigator_full_name>Benjamin Fernandez Gutierrez</investigator_full_name>
    <investigator_title>Rheumatologist</investigator_title>
  </responsible_party>
  <keyword>Supraspinatus tendon</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <keyword>OrthADAPT</keyword>
  <keyword>Rotator cuff</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT01687777
org study id: EC07/90208
secondary id: 2007-007630-19
nct id: NCT01687777
lead sponsor: 
collaborator: 
has dmc: No
Surgical reconstructive procedures for rotator cuff tears present a number of limitations.
      The few studies in which the repair integrity is evaluated, have shown the existence of a
      high rate of reruptures in spite of the fact that the functional results obtained short-term
      are satisfactory. Morphologic analysis from the sutures, after different follow-up periods,
      has not shown satisfactory results.

      Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells
      (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the
      function compared to cell-free tendon defect treatment.
The investigators will include: Patients with massive tears from the supraspinatus tendon, in
      which reconstructive surgery is indicated. Patients will be randomly stratified into two
      groups.

      The first group will receive autologous MSCs transplantation included in a collagen type I
      membrane (OrthADAPT) and the second group will serve as cell-free controls.

      The surgical procedure will be performed by arthroscopic and/or combined technique:
      arthroscopic subacromial decompression and mini-open rotator cuff repair. The OrthADAPT-cells
      composite will be put on the sutured area. The radiograms and function will be assessed by
      independently observers, who will no have knowledge of the study group from which they will
      have been obtained.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Constant Shoulder Score
time frame: up to 1 year
measure: Nuclear Magnetic Resonance (RMN)
time frame: 6 months, one year
arm group label: Mesenchymal stem cells (MSCs)
arm group type: Active Comparator
description: Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)
arm group label: OrthADAPT
arm group type: Placebo Comparator
description: Membrane of collagen type I (OrthoADAPT)
intervention type: Biological
intervention name: Mesenchymal Stem Cells (MSCs)
description: 20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
arm group label: Mesenchymal stem cells (MSCs)
intervention type: Biological
intervention name: OrthADAPT
arm group label: OrthADAPT
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Benjamin Fernandez-Gutierrez, MD, PhD
role: Principal Investigator
affiliation: Hospital Universitario Clinico San Carlos
last name: Pilar Tornero-Esteban, Bs, PhD
role: Study Director
affiliation: Hospital Universitario Clinico San Carlos
last name: Benjamín Fernández-Gutiérrez, PhD
phone: +34913303615
phone ext: 7803
email: bfernandez.hcsc@salud.madrid.org
last name: Pilar Tornero-Esteban, PhD
phone: +34913303615
phone ext: 7434
email: mptornero@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
citation: Awad HA, Butler DL, Boivin GP, Smith FN, Malaviya P, Huibregtse B, Caplan AI. Autologous mesenchymal stem cell-mediated repair of tendon. Tissue Eng. 1999 Jun;5(3):267-77. doi: 10.1089/ten.1999.5.267.
PMID: 10434073
citation: Awad HA, Boivin GP, Dressler MR, Smith FN, Young RG, Butler DL. Repair of patellar tendon injuries using a cell-collagen composite. J Orthop Res. 2003 May;21(3):420-31. doi: 10.1016/S0736-0266(02)00163-8.
PMID: 12706014
citation: Barber FA, Aziz-Jacobo J. Biomechanical testing of commercially available soft-tissue augmentation materials. Arthroscopy. 2009 Nov;25(11):1233-9. doi: 10.1016/j.arthro.2009.05.012. Epub 2009 Oct 2.
PMID: 19896044
citation: Bruder SP, Jaiswal N, Haynesworth SE. Growth kinetics, self-renewal, and the osteogenic potential of purified human mesenchymal stem cells during extensive subcultivation and following cryopreservation. J Cell Biochem. 1997 Feb;64(2):278-94. doi: 10.1002/(sici)1097-4644(199702)64:23.0.co;2-f.
PMID: 9027588
citation: Bruder SP, Kraus KH, Goldberg VM, Kadiyala S. The effect of implants loaded with autologous mesenchymal stem cells on the healing of canine segmental bone defects. J Bone Joint Surg Am. 1998 Jul;80(7):985-96. doi: 10.2106/00004623-199807000-00007.
PMID: 9698003
citation: Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.
PMID: 1870029
citation: Caplan AI. The mesengenic process. Clin Plast Surg. 1994 Jul;21(3):429-35.
PMID: 7924141
citation: Caplan AI. Review: mesenchymal stem cells: cell-based reconstructive therapy in orthopedics. Tissue Eng. 2005 Jul-Aug;11(7-8):1198-211. doi: 10.1089/ten.2005.11.1198.
PMID: 16144456
citation: Cofield RH, Parvizi J, Hoffmeyer PJ, Lanzer WL, Ilstrup DM, Rowland CM. Surgical repair of chronic rotator cuff tears. A prospective long-term study. J Bone Joint Surg Am. 2001 Jan;83(1):71-7. doi: 10.2106/00004623-200101000-00010.
PMID: 11205861
citation: Djurasovic M, Marra G, Arroyo JS, Pollock RG, Flatow EL, Bigliani LU. Revision rotator cuff repair: factors influencing results. J Bone Joint Surg Am. 2001 Dec;83(12):1849-55. doi: 10.2106/00004623-200112000-00013.
PMID: 11741065
citation: Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.
PMID: 14960664
citation: Gimbel JA, Van Kleunen JP, Lake SP, Williams GR, Soslowsky LJ. The role of repair tension on tendon to bone healing in an animal model of chronic rotator cuff tears. J Biomech. 2007;40(3):561-8. doi: 10.1016/j.jbiomech.2006.02.010. Epub 2006 Apr 4.
PMID: 16600252
citation: Goutallier D, Postel JM, Gleyze P, Leguilloux P, Van Driessche S. Influence of cuff muscle fatty degeneration on anatomic and functional outcomes after simple suture of full-thickness tears. J Shoulder Elbow Surg. 2003 Nov-Dec;12(6):550-4. doi: 10.1016/s1058-2746(03)00211-8.
PMID: 14671517
citation: Harryman DT 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen FA 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am. 1991 Aug;73(7):982-9.
PMID: 1874784
citation: Jaiswal N, Haynesworth SE, Caplan AI, Bruder SP. Osteogenic differentiation of purified, culture-expanded human mesenchymal stem cells in vitro. J Cell Biochem. 1997 Feb;64(2):295-312.
PMID: 9027589
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responsible party type: Principal Investigator
investigator affiliation: Hospital San Carlos, Madrid
investigator full name: Benjamin Fernandez Gutierrez
investigator title: Rheumatologist
mesh term: Chronic Disease
mesh term: Rotator Cuff Injuries