UnknownNot Applicable

Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study

United States260 participantsStarted 2017-03-24

Plain-language summary

Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction. A secondary injection will be administered at the time of repair in the supraspinatus muscle body medial to the musculotendonous junction.

Who can participate

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: * Included patients will have a repairable, full thickness rotator cuff tear limited to the supraspinatus and infraspinatus, confirmed by MRI. Patients with concomitant biceps tenotomy, tenodesis, arthroscopic subacromial decompression, and distal clavicle excision will be included. Exclusion Criteria: * Patients with prior operations on the shoulder, partial thickness tears, subscapularis tears or labral tears requiring repair, irreparable supraspinatus tears, staged bilateral rotator cuff repairs, or concomitant suprascapular nerve decompression will be excluded. We will also exclude patients with co-morbid conditions requiring the use of corticosteroids. Patients who cannot have an MRI for medical reasons will also be excluded.

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

Structural healing integrity

Timeframe: 1 year post-operation

Trial details

NCT IDNCT03379324

SponsorApplied Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-30

Contact for this trial

Hussein Elkousy, MD

8322899423 He700@fondren.com

View on ClinicalTrials.gov More Rotator Cuff Tear trials

Who can participate

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.