<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/NCT01724840</url>
  </required_header>
  <id_info>
    <org_study_id>GraftJacket01</org_study_id>
    <nct_id>NCT01724840</nct_id>
  </id_info>
  <brief_title>GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis</brief_title>
  <official_title>Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schulthess Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schulthess Klinik</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the&#xD;
      use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and&#xD;
      successfully used in TMC OA surgery and therefore represents an acceptable alternative for&#xD;
      avoiding possible donor-site morbidity. However, there are no randomised controlled trials&#xD;
      (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared.&#xD;
      Only with an RCT design it is possible to gain evidence about the advantages of one treatment&#xD;
      method over another. The main objective of the study is the comparison between two surgical&#xD;
      techniques for TMC OA: The resection interposition suspension arthroplasty using a part of&#xD;
      the flexor carpi radialis tendon as interpositional material and using the GraftJacket as&#xD;
      interpositional material.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Besides the use of the flexor carpi radialis tendon, several materials can serve as the&#xD;
      interposition tissue including Gore-Tex, silicone and other types of metal or polymer&#xD;
      implants. The use of Gore-Tex, silicone and metal implants, have been shown to carry high&#xD;
      complication rates secondary to synovitis and mechanical failure combined with poor patient&#xD;
      outcomes. A study about a porcine collagen xenograft was terminated prematurely because of&#xD;
      poor outcomes and adverse immunologic reactions.&#xD;
&#xD;
      Another option is using allograft, which is dermal or tendon tissue from another human donor&#xD;
      such as the GraftJacket (Wright Medical Technology, Inc., Arlington, TN). This product is&#xD;
      manufactured from donated cadaveric tissue that is treated to remove all cellular components&#xD;
      while preserving the native collagen scaffold. It thus provides the strength and integrity of&#xD;
      native autograft without the adverse immunologic response of traditional allograft. It is in&#xD;
      compliance with the American Association of Tissue Banks guidelines for allograft material,&#xD;
      and it is classified as human tissue for transplantation.&#xD;
&#xD;
      The GraftJacket shows high biocompatibility and the advantages compared to autograft are&#xD;
      avoiding donor site morbidity as well as decreased surgical time.&#xD;
&#xD;
      GraftJacket has mainly being used for the repair of rotator cuff tears and Achilles tendons&#xD;
      ruptures. No complications have been reported and patients showed significant improved&#xD;
      outcomes compared with their preoperative conditions. Although all of the studies show&#xD;
      methodological limitations due to the lack of a control group, these results show a great&#xD;
      potential and warrant further investigations.&#xD;
&#xD;
      In contrast to the studies already conducted in the Achilles tendon and shoulder joint, there&#xD;
      are only sparse data concerning other joints of the upper extremity such as the elbow and the&#xD;
      hand. Treating TMC OA of Eaton stage ll, lll and lV with GraftJacket has only been reported&#xD;
      in two studies. The patients under investigation reported significant pain relief,&#xD;
      significant improvements regarding grip and key pinch strength, good ability to perform&#xD;
      activities of daily living (ADL) and high satisfaction rates. No or only minimal&#xD;
      postoperative complications such as paraesthesia which are not directly related to the&#xD;
      GraftJacket have been reported. However, some limitations of these two studies have to be&#xD;
      acknowledges. Both are observational studies without control group making it impossible to&#xD;
      conclude if this approach is favourable compared to standard techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery</measure>
    <time_frame>preOP, 6 weeks, 3, 6, and 12months post OP</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis.</measure>
    <time_frame>preOP, 6 weeks, 3, 6, and 12months post OP</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Costs, Treatment satisfaction, objective and subjective function</measure>
    <time_frame>preOP, 6 weeks, 3, 6, and 12months post OP</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Osteoarthrosis of the Carpometacarpal Joint of the Thumb</condition>
  <arm_group>
    <arm_group_label>GraftJacket</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GraftJAcket is used as interpositional material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tendon Interposition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Flexor carpi radialis tendon is used as interpositional material</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>GraftJacket</intervention_name>
    <description>Interposition with GraftJacket</description>
    <arm_group_label>GraftJacket</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tendon Interposition</intervention_name>
    <description>Tendon Interposition with the FCR tendon</description>
    <arm_group_label>Tendon Interposition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  All adult patients diagnosed for TMC OA&#xD;
&#xD;
          -  willing to participate and provide informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients with rheumatoid arthritis,&#xD;
&#xD;
          -  pregnant women,&#xD;
&#xD;
          -  legal incompetent patients,&#xD;
&#xD;
          -  persons with insufficient knowledge of the German language to complete the&#xD;
             questionnaires&#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>Daniel B Herren, MD, MHA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schulthess Klinik</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schulthess Klinik</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>August 19, 2016</last_update_submitted>
  <last_update_submitted_qc>August 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schulthess Klinik</investigator_affiliation>
    <investigator_full_name>Daniel Herren</investigator_full_name>
    <investigator_title>MD, MHA</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT01724840
org study id: GraftJacket01
nct id: NCT01724840
lead sponsor: 
has dmc: No
Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the
      use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and
      successfully used in TMC OA surgery and therefore represents an acceptable alternative for
      avoiding possible donor-site morbidity. However, there are no randomised controlled trials
      (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared.
      Only with an RCT design it is possible to gain evidence about the advantages of one treatment
      method over another. The main objective of the study is the comparison between two surgical
      techniques for TMC OA: The resection interposition suspension arthroplasty using a part of
      the flexor carpi radialis tendon as interpositional material and using the GraftJacket as
      interpositional material.
Besides the use of the flexor carpi radialis tendon, several materials can serve as the
      interposition tissue including Gore-Tex, silicone and other types of metal or polymer
      implants. The use of Gore-Tex, silicone and metal implants, have been shown to carry high
      complication rates secondary to synovitis and mechanical failure combined with poor patient
      outcomes. A study about a porcine collagen xenograft was terminated prematurely because of
      poor outcomes and adverse immunologic reactions.

      Another option is using allograft, which is dermal or tendon tissue from another human donor
      such as the GraftJacket (Wright Medical Technology, Inc., Arlington, TN). This product is
      manufactured from donated cadaveric tissue that is treated to remove all cellular components
      while preserving the native collagen scaffold. It thus provides the strength and integrity of
      native autograft without the adverse immunologic response of traditional allograft. It is in
      compliance with the American Association of Tissue Banks guidelines for allograft material,
      and it is classified as human tissue for transplantation.

      The GraftJacket shows high biocompatibility and the advantages compared to autograft are
      avoiding donor site morbidity as well as decreased surgical time.

      GraftJacket has mainly being used for the repair of rotator cuff tears and Achilles tendons
      ruptures. No complications have been reported and patients showed significant improved
      outcomes compared with their preoperative conditions. Although all of the studies show
      methodological limitations due to the lack of a control group, these results show a great
      potential and warrant further investigations.

      In contrast to the studies already conducted in the Achilles tendon and shoulder joint, there
      are only sparse data concerning other joints of the upper extremity such as the elbow and the
      hand. Treating TMC OA of Eaton stage ll, lll and lV with GraftJacket has only been reported
      in two studies. The patients under investigation reported significant pain relief,
      significant improvements regarding grip and key pinch strength, good ability to perform
      activities of daily living (ADL) and high satisfaction rates. No or only minimal
      postoperative complications such as paraesthesia which are not directly related to the
      GraftJacket have been reported. However, some limitations of these two studies have to be
      acknowledges. Both are observational studies without control group making it impossible to
      conclude if this approach is favourable compared to standard techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery
time frame: preOP, 6 weeks, 3, 6, and 12months post OP
measure: Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis.
time frame: preOP, 6 weeks, 3, 6, and 12months post OP
measure: Costs, Treatment satisfaction, objective and subjective function
time frame: preOP, 6 weeks, 3, 6, and 12months post OP
arm group label: GraftJacket
arm group type: Experimental
description: GraftJAcket is used as interpositional material
arm group label: Tendon Interposition
arm group type: Active Comparator
description: Flexor carpi radialis tendon is used as interpositional material
intervention type: Procedure
intervention name: GraftJacket
description: Interposition with GraftJacket
arm group label: GraftJacket
intervention type: Procedure
intervention name: Tendon Interposition
description: Tendon Interposition with the FCR tendon
arm group label: Tendon Interposition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel B Herren, MD, MHA
role: Principal Investigator
affiliation: Schulthess Klinik
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Schulthess Klinik
investigator full name: Daniel Herren
investigator title: MD, MHA
mesh term: Osteoarthritis