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

Not Applicable

• Conditions: Scar; Fibrosis; Adhesions Nos Postoperative; Tendinopathy
• Interventions: Biological: Amnion Tendon Wrapping; Procedure: Surgical Tenolysis

• Registration Number: NCT03013582
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study First Submitted: 2016-12-20
• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06
• Primary Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amnion wrapping + Tenolysis	Surgical Tenolysis	Standard surgical tenolysis + wrapping of the released tendon with amnion.
Amnion wrapping + Tenolysis	Amnion Tendon Wrapping	Standard surgical tenolysis + wrapping of the released tendon with amnion.
Tenolysis control	Surgical Tenolysis	Standard surgical tenolysis alone

Primary Outcome Measures

Name	Time	Method
Passive Range of Motion (PROM)	6 months
Total Active Motion (TAM)	6 months

Secondary Outcome Measures

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