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

Thomas Jefferson University

Status: Unknown

Conditions: Adhesions Nos Postoperative; Fibrosis; Scar; Tendinopathy

Treatments: Biological: Amnion Tendon Wrapping; Procedure: Surgical Tenolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03013582

16D.538

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Amnion wrapping + Tenolysis

Experimental group

Description:

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

Treatment:

Biological: Amnion Tendon Wrapping

Procedure: Surgical Tenolysis

Tenolysis control

Placebo Comparator group

Description:

Standard surgical tenolysis alone

Treatment:

Procedure: Surgical Tenolysis