Recruiting

FlōGraft®

Sponsor:

Applied Biologics, LLC

Code:

NCT03379324

Conditions

Rotator Cuff Tear

Fatty Atrophy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Superiority of augmented repairs

Fat degeneration of supraspinatus muscle

Study Details

Brief 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.

Conditions

Rotator Cuff Tear

Fatty Atrophy

Study ID

NCT03379324

Start date

Mar 24, 2017

Status verified date

Dec, 2017

Completion date

Sep 30, 2019

Anticipated

Primary completion date

Sep 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Superiority of augmented repairs

Assess pain, function, and structural integrity of the rotator cuff at 3 months, 6 months, 1 year, and 2 years post-operation

active comparator: Fat degeneration of supraspinatus muscle

MRI assessment the quantity and disposition of fat within the supraspinatus muscle body compared to pre-operation MRI, at 1 year and 2 years post-operation

Interventions

Superiority of augmented repairs

4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body

Fat degeneration of supraspinatus muscle

4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body

Primary outcome measure

  • Structural healing integrity [ Time Frame: 1 year post-operation ]

Central Contacts and Locations

Central contacts

Hussein Elkousy, MD

8322899423He700@fondren.com

Dede Wilson

7137998600dede.wilson@hcahealthcare.com

Locations

Texas Orthopedic Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Dede Wilson

713-799-8600dede.wilson@hcahealthcare.com

Principal Investigator:

Hussein Elkousy, MD

More Information

Sponsor

Applied Biologics, LLC

Last update posted

Dec 20, 2017

Last verified

Dec, 2017

Keywords

  • Rotator Cuff
  • Human Amniotic Fluid
  • Amniotic Fluid Allograft
  • FlōGraft®
  • Amniotic Fluid Biologic
  • Fatty Atrophy
  • Fat Degeneration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Applied Biologics, LLC on 2017-12-20.