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

NCT03379324 | Unknown DMC

• 1 other identifier: TOH169
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Structural healing integrity

  Improved structural healing is the best indication of long-term surgery success. The Sugaya grading system is a method to account for structural integrity of the rotator cuff following surgery with five possible classifications. Sugaya scale: type I indicating sufficient thickness with homogeneously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, the presence of a minor discontinuity; and type V, the presence of a major discontinuity. Types I-III indicate different levels of healing. The classification of each shoulder must be assessed using MRIs (grade determined by a blinded musculoskeletal radiologist).

  1 year post-operation

Secondary Outcomes (8)

• Fatty degeneration

  1 year post-operation

• Structural healing integrity (2)

  2 years post-operation

• Fatty degeneration (2)

  2 years post-operation

• Functional outcome

  Baseline

• Functional outcome (2)

  3 months post-operation

Study Arms (2)

Superiority of augmented repairs

ACTIVE COMPARATOR

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

Biological: Superiority of augmented repairs; Biological: Fat degeneration of supraspinatus muscle

Fat degeneration of supraspinatus muscle

ACTIVE COMPARATOR

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

Biological: Superiority of augmented repairs; Biological: Fat degeneration of supraspinatus muscle

Interventions

Superiority of augmented repairs BIOLOGICAL

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

Also known as: FlōGraft®, Human amniotic fluid-derived allograft

Fat degeneration of supraspinatus muscle; Superiority of augmented repairs

Fat degeneration of supraspinatus muscle BIOLOGICAL

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

Also known as: FlōGraft®, Human amniotic fluid-derived allograft

Fat degeneration of supraspinatus muscle; Superiority of augmented repairs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Biologics, LLC: lead
• Fondren Orthopedic Group L.L.P.: collaborator
• Texas Orthopedic Hospital: collaborator

Study Sites (1)

Texas Orthopedic Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Gregory Stocks, MD

  Texas Orthopedic Hospital

  STUDY CHAIR

Central Study Contacts

Hussein Elkousy, MD

CONTACT

8322899423; He700@fondren.com

Dede Wilson

CONTACT

7137998600; dede.wilson@hcahealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Eligible patients will be randomized to FlōGraft®-augmented repair versus repair alone. Surgeons cannot be blinded to treatment; however, follow-up MRIs will be assessed by blinded radiologists.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a stratified, randomized, radiograph and patient blinded, prospective trial enrolling 260 subjects undergoing rotator cuff repair

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 20, 2017
• Study Start: March 24, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 20, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)