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
About this trial
This is an interventional treatment trial for Tendinopathy
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.
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
NCT ID
NCT03013582
First Posted
December 20, 2016
Last Updated
January 4, 2017
Sponsor
Thomas Jefferson University
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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