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

Patients will be given a written explanation of the study and screened for inclusion and
exclusion 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. 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.

All participants will volunteer to enroll in the study by signing informed consent
(Attachment B). All potential subjects will be over 18 years of age and capable of providing
their own informed consent. Patients will be recruited from the patient populations of Dr.
Edwards, Dr. Elkousy, Dr. Morris, Dr. Gombera and Dr Brown. The informed consent process will
be conducted by the investigators, their staff, or their research associates (e.g.,
orthopedic surgery fellows), who will explain the purpose and methods of the study, the risks
and benefits, and requirements of participation. Randomization to groups will occur following
informed consent; patients will not know to which group they are assigned.

1. Arthroscopic transosseous equivalent rotator cuff (TOE) repair will be performed; this
is our standard procedure, using suture anchors in the medial and lateral rows for a TOE
technique. The medial row will be 4.5 mm Polyether ether ketone (PEEK) anchors and the
lateral row will be a 5.5 mm PEEK knotless anchor. Medial row anchor sutures will be
tied.

2. FlōGraft® details: 4cc of FlōGraft® will be used in each treated patient, provided in a
single peel pouch containing two 2cc vials. In FlōGraft® treated patients, FlōGraft®
will be applied, following repair as detailed below.

3. FlōGraft® Preparation Protocol 3.1 Store FlōGraft® at -65◦C or colder until immediately
prior to use. 3.2 Remove box from cold storage, open exterior box and remove interior
package containing vials.

3.3 Neither the interior dust cover nor the outside of the vial are sterile. Do not
place either the interior package or the vial in sterile field.

3.4 Remove vials from packaging, place on non-sterile, secure, flat surface, or hold
vial firmly in one hand allowing contents to thaw (3-7 minutes.) Hold vial upright to
aspirate contents. Note: Allograft should be implanted immediately post-thaw, but not
later than eight (8) minutes post-thaw.

3.5 Pierce the vial cap and draw thawed solution into syringe. Do not pressurize vial
with air prior to extracting thawed FlōGraft® solution.

3.6 If needed, change needle size based on surgeon preference (18g to 23g.)

4. FlōGraft® Implantation 4.1 After the rotator cuff repair is completed, shut off
water-flow to joint. Excess water in joint is drained through the skin incisions,
creating a "dry" sub-acromial space.

4.2 Insert needle through skin incision or percutaneously. Under direct visualization,
inject FlōGraft® directly into rotator cuff tissue at repair site in approximately 0.50
cc aliquots. Cover entire repair site.

4.3 Implant allograft into the cuff muscle more medially to the repair in 0.25-0.5 cc
aliquots, as appropriate.

5. Postoperative management: 4 weeks immobilization in abduction sling; passive range of
motion will be initiated at the discretion of the surgeon based on tear size. Active
range of motion will begin at 8 weeks to 16 weeks.

6. Diagnostic MRI will be performed at one and two years postoperatively.

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.