Clinical trial NCT03013582: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Tendinopathy
Adhesions Nos Postoperative
Scar
Fibrosis
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total Active Motion (TAM)
timeFrame: 6 months
measure: Passive Range of Motion (PROM)
timeFrame: 6 months
Secondary outcomes:
measure: Patient-Rated Wrist Evaluation (PRWE)
timeFrame: 6 months
measure: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
timeFrame: 6 months
measure: Complications
timeFrame: 2 weeks, One month, 3 months, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Thomas Jefferson University-Philadelphia Hand Center
name: Randall W Culp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University-Philadelphia Hand Center
name: Michael P Gaspar, MD
role: STUDY_DIRECTOR
References:
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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.
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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: 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: 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.