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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Tendinopathy, Adhesions Nos Postoperative, Scar, Fibrosis

Intervention / Treatment
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* Biological: Amnion Tendon Wrapping
* Procedure: Surgical Tenolysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amnion wrapping + Tenolysis<br>Standard surgical tenolysis + wrapping of the released tendon with amnion. | Biological: Amnion Tendon Wrapping<br>* Tendon is wrapped with the allograft<br>Procedure: Surgical Tenolysis<br>* Surgical release of peritendinous scarred tissue<br>|
| Placebo Comparator: Tenolysis control<br>Standard surgical tenolysis alone | Procedure: Surgical Tenolysis<br>* Surgical release of peritendinous scarred tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Active Motion (TAM) |  | 6 months | 
| Passive Range of Motion (PROM) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Rated Wrist Evaluation (PRWE) | Validated Outcome score/questionnaire specific to wrist function | 6 months | 
| Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) | Validated Outcome score/questionnaire generalized to upper extremity conditions | 6 months | 
| Complications |  | 2 weeks, One month, 3 months, 6 months |