Rotator Cuff: Does the Vascularity Matter and the Role for PINPOINT

Background or rationale for this study:

4.5 million Patient's seek medical care for shoulder pain annually in the United States.

250,000 patients receive rotator cuff surgery in the United States annually. Those rotator
cuff surgeries produce a societal savings of $3.44 billion per year; averaging $13,771.00 per
patient younger than age 61. In which case rotator cuff tears Increases with age.

The Societal and Economic Value of Rotator Cuff Repair (AAOS) 2015 Rotator cuff repairs
result in a lifetime societal savings in the U.S. of approximately $3.44 billion annually.
Societal savings offset the direct costs of treatment in patients younger than age 61,
resulting in an average net savings of $13,771 per patient. This number significantly
increased to $77,662.00 for patients younger than 40 years of age.

Common problem, a 55 year-old man injured his left arm. He uses a sling and has difficulties
performing simple activities. 1 week later he falls develops immediate pain in his shoulder.
On examination he is unable to move his left arm in any upward or sideways direction without
supporting it with his other arm. Radiographs he brought show no signs of shoulder
osteoarthritis, dislocation, or fracture.

Shoulder pain is the third most common musculoskeletal reason for seeking medical care.
Although smaller tears are less likely to propagate, larger tears tend to progress with time
and eventually may become irreparable because of significant tendon retraction, muscle
atrophy, or both or when the tendons tissue quality does not allow repair.

In 1972-Neer proposed that 95% of rotator cuff injuries were caused by mechanical compression
under the coracoacromial arch, others argued cuff tear caused spur formation.

- Type I-flat

- Type II-curved

- Type III-hooked

Multifactorial:

Extrinsic factors;

- Subacromial impingement

- Glenohumeral instability

- Internal impingement

- Trauma (acute/repetitive) Intrinsic Factors;

- Tendon vascular supply

- Collagen fiber abnormalities

A positive painful arc test result and positive external rotation resistance test result were
the most accurate finding for detecting Rotator Cuff Disease; whereas the presence of a
positive lag tests (external or internal rotation) result was most accurate for diagnosis of
a full-thickness rotator cuff tear. Differentiating a full thickness tear from a partial
tear, the most sensitive test was the belly-press test (56.8%), and the most specific was the
lift-off test (96.95).

Bone microvascularization of the footprint plays a role in rotator Cuff healing. The use of
the Pinpoint may play a pivotal role in rotator Cuff healing, en lieu of Plasma Rich
platelets with variable results based on concentration levels.

6 level randomized controlled trials showed no clinically significant differences in Constant
scores, University of California, Los Angles shoulder rating (UCLA), and American Shoulder
and Elbow Surgeons (ASES) scores between double-row and single-row rotator cuff repair.
Overall odds ratio (OR) of intact rotator cuff tendon healing was 1.93 in patients treated
with double-row versus single-row repair, and the difference was significant.

A statistically significant benefit of double-row repair in the ASES and UCLA scores was
observed in the subgroup with tears greater than 3cm. The take home point; Double row may
improve structural healing: Clinical Relevance?

9 studies in the meta-analysis, 5 of which were randomized prospective studies (LEVEL1).

Double-row rotator cuff repair techniques have a significantly lower re-tear rate, higher
ASES score and greater range of motion of internal rotation compared with single-row repair
techniques. Point: Especially in those rotator cuff tears with a size >30mm, the double-row
technique is recommended for repair.

This was a Level 4 study out of the Cleveland Clinic which showed the majority of the tears
occurred between 6 and 24 weeks. The role of a potential hand held device can assess the
tendon quality in the office and change the rehab protocols based on tendon retraction.

Role for study interventions:

- Assessing the bony vascularity at the footprint and the tendon integrity.

- Current standard of care:

Steroid injection as a non-operatively treatment option. Could the steroid injections be
affecting the tendon micro vascularization? Could using the Pinpoint assess tendon quality
and long term healing a potential.

- Cystic osseous resorption and osteolysis.

- Breakdown products (PLLA) cause synovitis and chondrolysis.

- Breakdown products (PLLA) may interfere with healing-Complications of Bioabsorbable
Suture anchors in the shoulder.

Why Medical Row Knots?

- Enhances Biology be sealing footprint from synovial fluid.

- Compared to knotless medical row, better biomechanics incl. load to failure, stiffness,
less gap formation.

- A biomechanical comparison of 2 technical of double-row rotator cuff fixation: the
importance of medical row knots.

Clinical Implications and Surgeon's Role;

- Choice of a tissue-penetrating instrument; smaller penetrating devices resulting in
improves characteristics of stitch holding strength.

- Size of the tissue bite; bigger bite size being stronger.

- Most critical variable under a surgeons control during a rotator cuff repair is the
choice of the stitch.

Role for Pinpoint:

In the re-tear and partial-repair groups, postoperative tendon preservation at the middle
fact significantly affected the Japanese Orthopaedic Assocation (JOA) and UCLA scores
(P=.014, respectively). Considering the patients with tendon healing had better clinical
factors, the Pinpoint may help identify the tendon and footprint vascularity at time of
surgery.

Goals for the Pinpoint:

To attempt to show that increased vascularity may have an effect of the muscle quality,
therefore improving the strength and function long term.

Objective:

- This prospective study aims to obtain the accurate level within a range of a 95% CI
imaging Rotator Cuff tendons and the footprint.

- Ensure the Vascularity of the tendon after the footprint and the tendon have been
restored to the anatomic footprint. See if the level of the Rotator Cuff bite affects
the vascular flow of the tendon.

- Does tying the medical row or excessive tension change the vascularity of the Rotator
Cuff.

- We would like to see if by using the Pinpoint system it may be more cost effective then
Plasma Rich Platelet.

- Decrease the number of the re-tear rates in Rotator cuff repairs.

Overall goals: Improve long term patient function and outcomes. Increase Rotator Cuff healing
rates. Cost effective and time efficient method of Rotator Cuff evaluation during
arthroscopy.

Procedures involved (Research Interventions)

Patients undergoing a Rotator Cuff Repair:

- Pre-operatively Questioners to be completed at pre-op American Shoulder and Elbow
Surgeons (ASES), University California Los Angeles (UCLA), Disabilities of the arm,
shoulder and hand (DASH), Short Form Health Survey-12 (SF-12) & Short Form Health
Survey-36 (SF-36)

- Operative Collect OR information

- Post-operative ASES, UCLA, DASH SF-12 & SF-36

- Ultra sounds 3 months, 6 months, 1 year and 24 months

The operative intervention will proceed as current standard protocol dictates for the
described procedure. No changes in the operative technique will be undertaken apart from
injection of the dye and visualization with the camera. The idea would be to place the
Pinpoint probe within the subacrominal space, to check the vascular status of the tendon, and
then take a bite of the tendon and place the pinpoint back to check if the vascularity has
decreased. The Indocyanin Green dye kit will be used along with the PINPOINT system .
Patients with potential allergies or a history of allergies or sensitivity to sodium iodide
or iodinated contrast agents should not use this system, and will not be asked to
participate. The possible adverse reactions are, anaphylaxis, Hypotension, tachycardia,
dyspnea and urticarial. The duration of the procedure will be increased because of the study
imaging; this could be 15 to 30 minutes.

Inclusion Criteria:

1. Diagnosis of requiring Rotator Cuff repair surgical treatment

2. Willingness and ability to comply with the requirements of the protocol including
follow-up requirements.

3. Willing and able to sign a study specific informed consent form to participate.

4. Age range of ≥ 30 years old and ≤ 80 years old at time of surgery.

5. Male or female.

Exclusion Criteria:

1. Previous Rotator cuff repair or shoulder surgery.

2. Active systemic infection or infection at the operative site.

3. Co-morbid medical conditions of the upper extremities that may affect the neurological
and/or pain assessment.

4. History of an osteoporotic fracture.

5. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect
bone and mineral metabolism.

6. Taking medications that may interfere with bony/soft tissue healing including chronic
steroid use.

7. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV,
active hepatitis B or C or fibromyalgia.

8. Insulin-dependent type 1 or type 2 diabetes.

9. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient
death or have an effect on outcomes prior to study completion.

10. Pregnant, or intend to become pregnant, during the course of the study.

11. Severe obesity (Body Mass Index > 40).