Bio-Inductive Shoulder Patch:

A New Approach to Treating Rotator Cuff Injuries

Overview of the Bio-Inductive Patch:

Rotator cuff injury is common, and many patients avoid surgery because they hear about painful, lengthy postoperative rehabilitation and time away from work. This minimally invasive approach is designed as a new option for people suffering from rotator cuff tendon tears in the shoulder joint, which affect more than 4 million people annually in the U.S. and are the most common source of shoulder pain and disability.  The Bio-inductive Implant, manufactured by Rotation Medical, is suitable for most rotator cuff disease, from small partial-thickness tears to massive full-thickness tears.

Rotator cufftears are most often caused by chronic wear and tear with degeneration of the tendon. Rotator cuff tears can also occur in people who repeatedly perform overhead motions in their jobs or sports. In fact, more than 50 percent of people over age 60 have symptoms. Because traditional treatments do not address the poor quality of the underlying tendon tissue, a significant number of these tendons often develop into larger, more painful and debilitating tears and/or re-tears due to continuing degeneration of the torn tendon. The Bio-inductive Patch allows surgeons to intervene early and potentially prevent disease progression by augmenting and healing the tendon before the injury worsens.

Watch the video of Dr. Marc Pietropaoli discussing the Bio-Inductive Patch on Bridge Street (Channel 9 WSYR)

Inflammation and Impingement of the Rotator Cuff:

The rotator cuff is four muscles – one in front (the subscapularis), one on the top (the supraspinatus) and two in back (infraspinatus and teres minor). Strengthening these muscles will help a lot to dynamically stabilize the shoulder. The rotator cuff can usually be strengthened with rubber band type resistance as well as using 1- to 5-pound dumbbells.  A physical therapist teaches patients how to perform these exercises correctly. They also utilize various modalities to help such as ice, heat, ultrasound and electronic stimulation.

The supraspinatus sits in between two bones: the humeral head (the ball of the ball and socket) and the acromion (the tip of your shoulder bone).  In between the supraspinatus tendon and the acromion there is a bursa, which

is a little fluid filled sack that lubricates the tendon from the undersurface of the bone. Both the rotator cuff tendons and the bursa can get pinched in between the acromion and the humeral head and become inflamed.

“Itis” means inflammation so bursitis is “inflammation of the bursa;” whereas tendonitis is “inflammation of the tendon.” The two combined is often called impingement syndrome and can cause a rotator cuff injury. This all can be helped/treated by performing rotator cuff strengthening exercises. These can all be taught by a physical therapist. Sometimes, even this fails and then either a cortisone shot, an MRI and/or surgery are utilized.

Sometimes they are injured from a fall on an outstretched hand.  Sports or jobs with repeated overhead motion can also damage the rotator cuff.  You’re more likely to have this if you have a job where you need to move your arm a certain way over and over, like a painter or a carpenter, or you play sports like baseball, tennis , swimming, javelin, overhead sports.​ Aging causes tendons to wear down, which can lead to a tear as well. Some tears are not painful, but others can be very painful.  Dr. Pietropaoli believes that 80 to 90 percent of people who have some impingement syndrome don’t often need to have surgery.

What is a Rotator Cuff Tear?

There are two types of rotator cuff tears:​

  • Partial thickness tear – This type of tear is also called an incomplete tear.  It damages the tendon, but does not completely sever it. ​
  • Full-thickness tear – This type of tear is also called a complete tear.  It separates all of the tendon from the bone and/or is a full hole within the tendon itself.   ​

What causes your Rotator Cuff to tear?

Rotator cuff problems are caused by a variety of factors including genecs, trauma, age or acvity-related injury. The most common cause is a process called degenerave tendinosis.  As we age, our rotator cuff tendons wear out like a well-worn pair of jeans. These tendons are subject to stress and wear and have poor blood supply. Over me, the tendon becomes thinner and is more suscepble to tearing. As this degeneraon progresses, rotator cuff tears can become increasingly larger and more painful

Symptoms of a Tear:

  • With a rotator cuff injury, you will typically feel pain in the front and side of your shoulder that radiates down the side of your arm. ​
  • You may also feel pain when lifting your arm overhead, reach behind your back, or when you try to sleep on the affected side. ​
  • If the tear occurs with injury, you may experience acute pain, a snapping sensation and immediate weakness of the arm/inability to lift the arm overhead.

Approximately 25% to 50% of U.S. adults over 40 years of age have a rotator cuff tear.

A New Approach: The Rotation Medical Rotator Cuff System

The Rotational Medical Rotator Cuff System is a new technology designed to improve the treatment of rotator cuff disease.  At Victory Sports Medicine & Orthopedics, Dr. Pietropaoli is pioneering the use of a breakthrough technology designed as a new option for millions of people suffering from rotator cuff tendon tears in the shoulder joint. This new, minimally invasive solution, the Rotation Medical Bio-inductive Patch, goes beyond traditional surgery to help the tendon heal through the induction of new tendinous tissue growth

The technology can be used in earlier stages of rotator cuff disease to slow progression of your rotator cuff disease. Addressing the injury earlier can shorten recovery time, reduce pain and improve quality of life. Intervening before a full tear has occurred may also decrease your chances of requiring traditional rotator cuff surgery.  The technology can also be used in conjunction with traditional repair procedures to improve the tendon biology and decrease the chance of your rotator cuff tendon re-tearing.

What is it?

The technology includes a collagen based bio-inductive implant about the size of a postage stamp. This implant is delivered arthroscopically through a small incision over the location of your rotator cuff tendon injury. Your physician will secure it in place with small staples.

This first-of-its-kind implant induces the formation of new tendinous tissue for the treatment of rotator cuff disease. Not only does this new approach augment the tendons that are vital to proper functioning of the rotator cuff, it can potentially prevent the progression of rotator cuff disease, both in situations where partial-thickness tears might progress to full-thickness tears or where re-tears of full-thickness repairs are likely.

Watch a short animated video on the Bio-Inductive Shoulder Patch procedure.

About the Surgery:

The Rotation Medical Bio-inductive Patch biologically augments the tendon through the induction of new tendinous tissue growth of the supraspinatus tendon to help reduce the peak strain at the site of the tear and create an environment for the patient’s tendon to heal.

The patch is inserted through a small incision during a short, minimally-invasive procedure. Derived from bovine Achilles tendon, the implant is held in place with surgical staples until new tissue grows into the implant and remodels into tendon-like tissue. The surgical staples hold the implant in place until new tissue grows into the implant and remodels into tendon-like tissue. The implant gradually absorbs within about six months, leaving a layer of new tendinous tissue to biologically augment the existing tendon in doing its job of moving and stabilizing the shoulder during day-to-day activities.

How does the patch work?

After implantation, the bio-inductive implant dissolves slowly. This implant has been shown in clinical studies to heal the tendon by inducing the growth of new tendon- like issue, resulting in thicker tendons and replacement of issue defects.  The new issue growth occurs within weeks of implantation, enhancing the body’s natural healing response and thickening the tendon to help restore good attachment of your tendon to your shoulder bone.

How does the Rotation Medical Implant benefit you?

Depending on the stage of your rotator cuff disease, the Rotation Medical Rotator Cuff Repair System can potentially provide a range of benefits:

  • Shorter rehabilitation
  • Faster recovery
  • Potential to prevent or slow down disease progression
  • Decreased risk of developing a second degenerative tear
  • Healing of partial-thickness tears

Recent Study on the Bio-Inductive Implant:

There is a growing body of evidence demonstrating the ability of the implant to safely induce new tendinous tissue. A first-in-man study conducted in Sydney, Australia, enrolled 24 patients who required rotator cuff surgery in a prospective, multi-center, non-randomized trial. Patients with partial- or full-thickness supraspinatus tendon tears underwent arthroscopic subacromial decompression (ASD) followed by implantation of the Rotation Medical Bio-inductive Implant.

For partial-thickness tears the implant was placed over the tendon without repair; for full-thickness tears the implant was placed over a traditional repair. MRI results showed that a layer of new tendinous tissue was induced in all of the patients, with a 64 percent increase in tendon thickness. In addition, partial-thickness defects were filled in without any evidence of tear progression, and there were no re-tears in the full-thickness repair patients. There were no observations of adverse reactions to the implant, and all patients showed consistent improvement in clinical scores. 

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