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

January 4, 2017 updated by: Thomas Jefferson University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Randall W Culp, MD, Thomas Jefferson University-Philadelphia Hand Center
  • Study Director: Michael P Gaspar, MD, Thomas Jefferson University-Philadelphia Hand Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16D.538

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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