<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/NCT03013582</url>
  </required_header>
  <id_info>
    <org_study_id>16D.538</org_study_id>
    <nct_id>NCT03013582</nct_id>
  </id_info>
  <brief_title>Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist</brief_title>
  <official_title>A Prospective Randomized Trial Comparing Tendon Wrapping With Amniotic Membrane and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand and Wrist</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <brief_summary>
    <textblock>
      Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand&#xD;
      therapists alike. Despite their commonality, no consensus exists as to the best means of&#xD;
      preventing adhesions, or the most ideal methods to treat them once they have occurred. The&#xD;
      purpose of this study is to compare patient outcomes after standard operative tenolysis&#xD;
      performed for adhesions of the hand to outcomes after tenolysis with the use of allograft&#xD;
      human amniotic membrane.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who are scheduled to undergo operative tenolysis of the flexor and/or extensor&#xD;
      tendons of the hand will be recruited. Our target enrollment is 40 patients (20 control plus&#xD;
      20 experimental), based on the power analysis detailed in the next paragraph. Enrolled&#xD;
      patients will be randomized to either standard operative tenolysis, or tenolysis with&#xD;
      placement of AlloWrap. Randomization will be performed by computerized random number&#xD;
      generator. All surgeries will be performed by one senior fellowship-trained hand surgeon.&#xD;
      Baseline measurements of total active motion (TAM), passive range of motion (PROM), and&#xD;
      survey scores of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Patient&#xD;
      Rated Wrist Evaluation (PRWE) will be recorded pre-operatively. In addition, patients' pain&#xD;
      level will be assessed using the visual analog scale (VAS) both at rest, and during the&#xD;
      examination. These same values will be re-evaluated at post-operative follow-up visits at 2&#xD;
      weeks, 1 month, 3 months and 6 months. PROM will also be evaluated intra-operatively by the&#xD;
      surgeon, and documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">July 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Active Motion (TAM)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Passive Range of Motion (PROM)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-Rated Wrist Evaluation (PRWE)</measure>
    <time_frame>6 months</time_frame>
    <description>Validated Outcome score/questionnaire specific to wrist function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)</measure>
    <time_frame>6 months</time_frame>
    <description>Validated Outcome score/questionnaire generalized to upper extremity conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>2 weeks, One month, 3 months, 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Tendinopathy</condition>
  <condition>Adhesions Nos Postoperative</condition>
  <condition>Scar</condition>
  <condition>Fibrosis</condition>
  <arm_group>
    <arm_group_label>Amnion wrapping + Tenolysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard surgical tenolysis + wrapping of the released tendon with amnion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tenolysis control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard surgical tenolysis alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Amnion Tendon Wrapping</intervention_name>
    <description>Tendon is wrapped with the allograft</description>
    <arm_group_label>Amnion wrapping + Tenolysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Tenolysis</intervention_name>
    <description>Surgical release of peritendinous scarred tissue</description>
    <arm_group_label>Amnion wrapping + Tenolysis</arm_group_label>
    <arm_group_label>Tenolysis control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients deemed candidates for operative tenolysis of the hand or wrist&#xD;
&#xD;
          -  Age ≥18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years at the time of surgery;&#xD;
&#xD;
          -  Any patient who would not be able or willing to comply with the protocol or perform&#xD;
             assessments;&#xD;
&#xD;
          -  Patients with medical conditions that may preclude placement of human biological&#xD;
             membrane;&#xD;
&#xD;
          -  Patients who have previously undergone tenolysis on the operative hand;&#xD;
&#xD;
          -  Patients that will have multiple surgeries that are deemed as possible confounders,&#xD;
             particularly those requiring an additional incision;&#xD;
&#xD;
          -  Is physically or mentally compromised (i.e. being currently treated for a psychiatric&#xD;
             disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his&#xD;
             or her ability to participate in the clinical study;&#xD;
&#xD;
          -  Is a prisoner;&#xD;
&#xD;
          -  Is a transient.&#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>Randall W Culp, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University-Philadelphia Hand Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael P Gaspar, MD</last_name>
    <role>Study Director</role>
    <affiliation>Thomas Jefferson University-Philadelphia Hand Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael P Gaspar, MD</last_name>
    <email>michaelpgaspar@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006.</citation>
    <PMID>15882604</PMID>
  </reference>
  <reference>
    <citation>Rouhani A, Tabrizi A, Ghavidel E. Effects of non-steroidal anti-inflammatory drugs on flexor tendon rehabilitation after repair. Arch Bone Jt Surg. 2013 Sep;1(1):28-30. Epub 2013 Sep 15.</citation>
    <PMID>25207280</PMID>
  </reference>
  <reference>
    <citation>Kohanzadeh S, Lugo L, Long JN. Safety of antiadhesion barriers in hand surgery. Ann Plast Surg. 2013 May;70(5):527-9. doi: 10.1097/SAP.0b013e31827eace2.</citation>
    <PMID>23542850</PMID>
  </reference>
  <reference>
    <citation>Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31.</citation>
    <PMID>24560801</PMID>
  </reference>
  <reference>
    <citation>Wu YF, Tang JB. Apoptosis in adhesions and the adhesion-tendon gliding interface: relationship to adhesion-tendon gliding mechanics. J Hand Surg Am. 2013 Jun;38(6):1071-8. doi: 10.1016/j.jhsa.2013.03.012. Epub 2013 May 6.</citation>
    <PMID>23660197</PMID>
  </reference>
  <reference>
    <citation>Ozboluk S, Ozkan Y, Ozturk A, Gul N, Ozdemir RM, Yanik K. The effects of human amniotic membrane and periosteal autograft on tendon healing: experimental study in rabbits. J Hand Surg Eur Vol. 2010 May;35(4):262-8. doi: 10.1177/1753193409337961. Epub 2009 Aug 17.</citation>
    <PMID>19687075</PMID>
  </reference>
  <reference>
    <citation>Branford OA, Lee DA, Bader DL, Grobbelaar AO. The mechanics of flexor tendon adhesions. J Hand Surg Eur Vol. 2012 Jul;37(6):555-63. doi: 10.1177/1753193411432675. Epub 2011 Dec 14.</citation>
    <PMID>22170243</PMID>
  </reference>
  <reference>
    <citation>Gaspar MP, Abdelfattah HM, Welch IW, Vosbikian MM, Kane PM, Rekant MS. Recurrent cubital tunnel syndrome treated with revision neurolysis and amniotic membrane nerve wrapping. J Shoulder Elbow Surg. 2016 Dec;25(12):2057-2065. doi: 10.1016/j.jse.2016.09.013. Epub 2016 Oct 14.</citation>
    <PMID>27751716</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Tissue Adhesions</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/NCT03013582
org study id: 16D.538
nct id: NCT03013582
lead sponsor: 
Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand
      therapists alike. Despite their commonality, no consensus exists as to the best means of
      preventing adhesions, or the most ideal methods to treat them once they have occurred. The
      purpose of this study is to compare patient outcomes after standard operative tenolysis
      performed for adhesions of the hand to outcomes after tenolysis with the use of allograft
      human amniotic membrane.
Patients who are scheduled to undergo operative tenolysis of the flexor and/or extensor
      tendons of the hand will be recruited. Our target enrollment is 40 patients (20 control plus
      20 experimental), based on the power analysis detailed in the next paragraph. Enrolled
      patients will be randomized to either standard operative tenolysis, or tenolysis with
      placement of AlloWrap. Randomization will be performed by computerized random number
      generator. All surgeries will be performed by one senior fellowship-trained hand surgeon.
      Baseline measurements of total active motion (TAM), passive range of motion (PROM), and
      survey scores of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Patient
      Rated Wrist Evaluation (PRWE) will be recorded pre-operatively. In addition, patients' pain
      level will be assessed using the visual analog scale (VAS) both at rest, and during the
      examination. These same values will be re-evaluated at post-operative follow-up visits at 2
      weeks, 1 month, 3 months and 6 months. PROM will also be evaluated intra-operatively by the
      surgeon, and documented.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Total Active Motion (TAM)
time frame: 6 months
measure: Passive Range of Motion (PROM)
time frame: 6 months
measure: Patient-Rated Wrist Evaluation (PRWE)
time frame: 6 months
description: Validated Outcome score/questionnaire specific to wrist function
measure: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
time frame: 6 months
description: Validated Outcome score/questionnaire generalized to upper extremity conditions
measure: Complications
time frame: 2 weeks, One month, 3 months, 6 months
arm group label: Amnion wrapping + Tenolysis
arm group type: Experimental
description: Standard surgical tenolysis + wrapping of the released tendon with amnion.
arm group label: Tenolysis control
arm group type: Placebo Comparator
description: Standard surgical tenolysis alone
intervention type: Biological
intervention name: Amnion Tendon Wrapping
description: Tendon is wrapped with the allograft
arm group label: Amnion wrapping + Tenolysis
intervention type: Procedure
intervention name: Surgical Tenolysis
description: Surgical release of peritendinous scarred tissue
arm group label: Amnion wrapping + Tenolysis
arm group label: Tenolysis control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Randall W Culp, MD
role: Principal Investigator
affiliation: Thomas Jefferson University-Philadelphia Hand Center
last name: Michael P Gaspar, MD
role: Study Director
affiliation: Thomas Jefferson University-Philadelphia Hand Center
last name: Michael P Gaspar, MD
email: michaelpgaspar@gmail.com
citation: Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006.
PMID: 15882604
citation: Rouhani A, Tabrizi A, Ghavidel E. Effects of non-steroidal anti-inflammatory drugs on flexor tendon rehabilitation after repair. Arch Bone Jt Surg. 2013 Sep;1(1):28-30. Epub 2013 Sep 15.
PMID: 25207280
citation: Kohanzadeh S, Lugo L, Long JN. Safety of antiadhesion barriers in hand surgery. Ann Plast Surg. 2013 May;70(5):527-9. doi: 10.1097/SAP.0b013e31827eace2.
PMID: 23542850
citation: Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31.
PMID: 24560801
citation: Wu YF, Tang JB. Apoptosis in adhesions and the adhesion-tendon gliding interface: relationship to adhesion-tendon gliding mechanics. J Hand Surg Am. 2013 Jun;38(6):1071-8. doi: 10.1016/j.jhsa.2013.03.012. Epub 2013 May 6.
PMID: 23660197
citation: Ozboluk S, Ozkan Y, Ozturk A, Gul N, Ozdemir RM, Yanik K. The effects of human amniotic membrane and periosteal autograft on tendon healing: experimental study in rabbits. J Hand Surg Eur Vol. 2010 May;35(4):262-8. doi: 10.1177/1753193409337961. Epub 2009 Aug 17.
PMID: 19687075
citation: Branford OA, Lee DA, Bader DL, Grobbelaar AO. The mechanics of flexor tendon adhesions. J Hand Surg Eur Vol. 2012 Jul;37(6):555-63. doi: 10.1177/1753193411432675. Epub 2011 Dec 14.
PMID: 22170243
citation: Gaspar MP, Abdelfattah HM, Welch IW, Vosbikian MM, Kane PM, Rekant MS. Recurrent cubital tunnel syndrome treated with revision neurolysis and amniotic membrane nerve wrapping. J Shoulder Elbow Surg. 2016 Dec;25(12):2057-2065. doi: 10.1016/j.jse.2016.09.013. Epub 2016 Oct 14.
PMID: 27751716
responsible party type: Sponsor
mesh term: Tendinopathy
mesh term: Tissue Adhesions