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Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist

Primary Purpose

Tendinopathy, Adhesions Nos Postoperative, Scar

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Amnion Tendon Wrapping
Surgical Tenolysis
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adult patients deemed candidates for operative tenolysis of the hand or wrist
  • Age ≥18

Exclusion Criteria:

  • Patients younger than 18 years at the time of surgery;
  • Any patient who would not be able or willing to comply with the protocol or perform assessments;
  • Patients with medical conditions that may preclude placement of human biological membrane;
  • Patients who have previously undergone tenolysis on the operative hand;
  • Patients that will have multiple surgeries that are deemed as possible confounders, particularly those requiring an additional incision;
  • Is physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study;
  • Is a prisoner;
  • Is a transient.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Amnion wrapping + Tenolysis

    Tenolysis control

    Arm Description

    Standard surgical tenolysis + wrapping of the released tendon with amnion.

    Standard surgical tenolysis alone

    Outcomes

    Primary Outcome Measures

    Total Active Motion (TAM)
    Passive Range of Motion (PROM)

    Secondary Outcome Measures

    Patient-Rated Wrist Evaluation (PRWE)
    Validated Outcome score/questionnaire specific to wrist function
    Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
    Validated Outcome score/questionnaire generalized to upper extremity conditions
    Complications

    Full Information

    First Posted
    December 20, 2016
    Last Updated
    January 4, 2017
    Sponsor
    Thomas Jefferson University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03013582
    Brief Title
    Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Thomas Jefferson University

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tendinopathy, Adhesions Nos Postoperative, Scar, Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Amnion wrapping + Tenolysis
    Arm Type
    Experimental
    Arm Description
    Standard surgical tenolysis + wrapping of the released tendon with amnion.
    Arm Title
    Tenolysis control
    Arm Type
    Placebo Comparator
    Arm Description
    Standard surgical tenolysis alone
    Intervention Type
    Biological
    Intervention Name(s)
    Amnion Tendon Wrapping
    Intervention Description
    Tendon is wrapped with the allograft
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical Tenolysis
    Intervention Description
    Surgical release of peritendinous scarred tissue
    Primary Outcome Measure Information:
    Title
    Total Active Motion (TAM)
    Time Frame
    6 months
    Title
    Passive Range of Motion (PROM)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Patient-Rated Wrist Evaluation (PRWE)
    Description
    Validated Outcome score/questionnaire specific to wrist function
    Time Frame
    6 months
    Title
    Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
    Description
    Validated Outcome score/questionnaire generalized to upper extremity conditions
    Time Frame
    6 months
    Title
    Complications
    Time Frame
    2 weeks, One month, 3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All adult patients deemed candidates for operative tenolysis of the hand or wrist Age ≥18 Exclusion Criteria: Patients younger than 18 years at the time of surgery; Any patient who would not be able or willing to comply with the protocol or perform assessments; Patients with medical conditions that may preclude placement of human biological membrane; Patients who have previously undergone tenolysis on the operative hand; Patients that will have multiple surgeries that are deemed as possible confounders, particularly those requiring an additional incision; Is physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study; Is a prisoner; Is a transient.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael P Gaspar, MD
    Email
    michaelpgaspar@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Randall W Culp, MD
    Organizational Affiliation
    Thomas Jefferson University-Philadelphia Hand Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Michael P Gaspar, MD
    Organizational Affiliation
    Thomas Jefferson University-Philadelphia Hand Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15882604
    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.
    Results Reference
    background
    PubMed Identifier
    25207280
    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.
    Results Reference
    background
    PubMed Identifier
    23542850
    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.
    Results Reference
    background
    PubMed Identifier
    24560801
    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.
    Results Reference
    background
    PubMed Identifier
    23660197
    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.
    Results Reference
    background
    PubMed Identifier
    19687075
    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.
    Results Reference
    background
    PubMed Identifier
    22170243
    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.
    Results Reference
    background
    PubMed Identifier
    27751716
    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.
    Results Reference
    background

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    Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist

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