UnknownNot Applicable

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

40 participantsStarted 2017-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Active Motion (TAM)

Timeframe: 6 months

Passive Range of Motion (PROM)

Timeframe: 6 months

Trial details

NCT IDNCT03013582

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07

Contact for this trial

Michael P Gaspar, MD

michaelpgaspar@gmail.com

View on ClinicalTrials.gov More Tendinopathy trials