Bioinductive Implant

Florida Orthopaedic Institute is now using a new breakthrough procedure to treat patients with rotator cuff disease. The Rotation Medical Bioinductive Implant biologically helps tendons heal through the induction of new tissue growth, helping patients resume normal activities quicker than traditional treatments, while reducing the likelihood of further degeneration or re-tears.

This minimally invasive system is a new option for people suffering from rotator cuff tendon tears in the shoulder joint. Rotator cuff tears are the most common source of shoulder pain and disability, affecting more than 4 million people a year in the U.S. Many patients avoid rotator cuff surgery because they have heard about painful, lengthy postoperative rehabilitation and time away from work.

Rotation Medical Bioinductive Implant

About the size of a postage stamp, the Rotation Medical Bioinductive Implant is inserted through a small incision during a minimally invasive procedure. Bioinductive implants induce the formation of new tendinous tissue over the surface of the tendon, resulting in a thicker tendon. Depending on the stage of rotator cuff disease, the bioinductive implant provides patients a range of potential benefits, including shorter rehabilitation, faster recovery, prevention or slowing of disease progression, healing of partial-thickness tears, and decreased risk of developing a subsequent tear.

Rotator Cuff Injuries

Surrounding the shoulder joint, the rotator cuff is a group of muscles and tendons that surround, move and stabilize the shoulder joint. The rotator cuff keeps the head of the upper arm bone firmly within the shallow socket of the shoulder. Rotator cuff injuries usually cause a dull ache in the shoulders, which can worsen when sleeping on the injured side. A torn rotator cuff can make daily activities like getting dressed, sleeping or brushing your teeth painful and difficult to do. They can prevent you from doing things like work, or things that you love to do like playing sports and living an active lifestyle.

When a rotator cuff tear occurs, the tendon separates from the humeral head (the top of the upper arm bone). There are two types of rotator cuff tears:

• Partial – Where the soft tissue is damaged but the tendon is not completely torn away. Typically caused by aging, weakness, or overuse of the tendon.
• Complete – also known as a full thickness tear, when the soft tissue is completely separated from the bone. In most cases, the rotator cuff tendon tears directly off the attachment site.

Causes and Risk Factors

Rotator cuff tears are usually caused by persistent wear and tear with degeneration of the tendon. It is estimated that four million people in the United States suffer from rotator cuff disease, and approximately 25% to 50% of U.S. adults over 40 years of age have a rotator cuff tear. Rotator cuff tears occur in people who repeatedly perform overhead motions in their jobs or sports, as well as the following factors.

AGE – The risk of rotator cuff injury increases with age. Torn rotator cuffs are the more common in people ages 35 and older. More than 50 percent of people over age 60 have rotator cuff injury symptoms.

SPORTS – Repetitive arm motions, like those above the head and behind the back, increase the chance of a rotator cuff injury. Sports where athletes regularly perform such actions include golf, baseball, archery, swimming, surfing, and tennis.

WORK – Manual laborers who use repetitive overhead movements are more prone to rotator cuff injuries. Construction workers, carpenters, house painters, firefighters, and law-enforcement officials have an increased risk of this type of injury.

GENETICS – If torn rotator cuffs are common in your family, you may be at an increased risk with a predisposition for frayed or weak shoulder tendons.Overuse injuries from continually over-exerting activities are the some of the major cause of bursitis or tendinitis. Overuse injuries are commonly found in individuals who play competitive sports, but can also be related to repetitive activities such as painting or stocking shelves. The overuse activities cause friction and scraping of the rotator cuff and its nearby joints. Bursitis or tendinitis is cared for by moderating and reducing the activity, along with a rehabilitation program prescribed by a Florida Orthopaedic Shoulder specialist.

Rotator Cuff Symptoms

• Pain in the shoulder, especially when lifting or lowering the arm, or while lying on the affected shoulder.
• Often described as a dull ache deep in the shoulder.
• Disturbed sleep, particularly if you lie on the affected shoulder.
• Difficult to comb your hair or reach behind your back.
• Weakness in the affected arm, especially when lifting and rotating the arm.
• Locking of the shoulder.
• A crackling sensation when the shoulder is moved in certain positions.
• Feeling like the shoulder is “catching”.
• A feeling of instability in the shoulder.

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 incapacitating tears or re-tears due to continuing degeneration of the torn tendon. Bioinductive implants allow Florida Orthopaedic surgeons to intervene early and help prevent disease progression by augmenting and healing the tendon before the injury worsens.

Conventional surgery to repair rotator cuffs is effective, but repairs take a long time to heal. In the repaired area, there are a low number of cells to assist in healing, and a poor blood supply. The mechanical load on tendons is high, which can cause a repaired tendon to re-tear. Overuse injuries from continually over-exerting activities are the some of the major cause of bursitis or tendinitis. Overuse injuries are commonly found in individuals who play competitive sports, but can also be related to repetitive activities such as painting or stocking shelves. The overuse activities cause friction and scraping of the rotator cuff and its nearby joints. Bursitis or tendinitis is cared for by moderating and reducing the activity, along with a rehabilitation program prescribed by a Florida Orthopaedic Shoulder specialist.

Using Bioinductive Implants to Repair and Heal Rotator Cuff Injuries

Manufactured by Rotation Medical, bioinductive implants are suitable for most rotator cuff disease, from small partial-thickness tears to massive full-thickness tears. They are derived from bovine Achilles tendon and gradually absorbed within six months, leaving a layer of new tendon-like tissue to biologically increase the existing tendon. This treatment can be used for both previously treated and untreated patients. Introduced to the market in 2014, the technology has been used in thousands of rotator cuff procedures in the U.S.

Not all patients with painful rotator cuffs require surgery. Nonsurgical treatments, like modified activities, strengthening exercises, physical therapy and steroid injections can be used in many cases to treat the shoulder. At Florida Orthopaedic, our philosophy is to first try all appropriate nonsurgical methods to increase mobility and function. Then, and only then, do we suggest surgery.

Several surgeons at Florida Orthopaedic have undergone extensive training and have performed many bioinductive implants. For more information and to find out if a bioinductive implant procedure is right for you, call to schedule a consultation with one of our orthopedic surgeons who specialize in rotator cuff tear treatments.Overuse injuries from continually over-exerting activities are the some of the major cause of bursitis or tendinitis. Overuse injuries are commonly found in individuals who play competitive sports, but can also be related to repetitive activities such as painting or stocking shelves. The overuse activities cause friction and scraping of the rotator cuff and its nearby joints. Bursitis or tendinitis is cared for by moderating and reducing the activity, along with a rehabilitation program prescribed by a Florida Orthopaedic Shoulder specialist.

Questions & Answers

What is the Rotation Medical Bioinductive Implant?

The Rotation Medical Bioinductive Implant is a collagen-based implant about the size of a postage stamp. It is delivered arthroscopically through a small incision located over the injured rotator cuff tendon and attached with proprietary staples. The Bioinductive Implant induces the formation of new tendinous tissue over the surface of the tendon, resulting in a thicker tendon. It is the first and only implant to clinically demonstrate that it induces new tendinous tissue growth, helping tendons heal.

The Rotation Medical Bioinductive Implant can be used early in the disease before it progresses and has potential to prevent disease progression and reduce re-tear rates by addressing the underlying root cause – excessive stress and strain in the tendon.

How does the technology work?

The Rotation Medical Bioinductive Implant is highly porous. Shortly after implantation new fibrovascular tissue completely fills the porosity of the implant. The Implant is designed with unique biomechanical properties that induce this new tissue to remodel into linearly oriented, tendon-like tissue. As part of the remodeling process the implant gradually absorbs within about six months, leaving a layer of new tissue to biologically augment the existing tendon. Due to the very high purity of the implant, there has not been any observation of an adverse inflammatory response or foreign body reaction associated with the implant.

What are the benefits of the Bioinductive Implant?

Depending on the stage of rotator cuff disease, the Bioinductive Implant can provide a range of potential benefits for patients(1), including:

• Shorter rehabilitation, with decreased sling time.
• Faster recovery, with less physical therapy.
• Prevention or slowing of disease progression.
• Healing of partial-thickness tears.
• Decreased risk of developing a subsequent degenerative tear.

What are the drawbacks of traditional treatments?

Traditional approaches to treating rotator cuff injuries focus only on mechanical repair, but do not address the underlying biology of the tendon. Additional details of traditional treatments:

• Have high incidence of failures – a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear.
• Many patients avoid and/or delay surgery because of painful and long rehab and surgical failures.

How common are rotator cuff injuries in the U.S.?

• Rotator cuff disease is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S.
• Many people choose to forego surgery until pain is severe and range of motion is significantly impaired. However, as rotator cuff disease progresses, it can become increasingly difficult for a surgeon to repair.

Is there clinical evidence to support this new technology?

There is a growing body of evidence demonstrating the ability of the Bioinductive Implant to safely induce new tendinous tissue growth:

• Multiple studies have shown that the technology is safe and effective.
• FDA clearance was obtained in spring 2014.
• Thousands of patients have received the Rotation Medical Bioinductive Implant in the U.S.

(1) Currently there is no definitive clinical evidence to support that the implant reduces pain or gets patients back to activities more quickly. However, in some cases the implant shortened or sped up rehabilitation, which may get patients back to activities more quickly.

(2,4) Ken Yamaguchi, Konstantinos Ditsios, William D. Middleton, Charles F. Hildebolt,Leesa M. Galatz, Sharlene A. Teefey; The Demographic and Morphological Features of Rotator Cuff Disease: A Comparison of Asymptomatic and Symptomatic Shoulders. J Bone & Joint Surgery. 2006 Aug; 88(8): 1699-1704.

(3) Commissioned Market Research Report

(5) Nathan A. Mall, Miho J. Tanaka, Luke S. Choi, George Paletta, Jr.; Factors Affecting Rotator Cuff Healing. J Bone & Joint Surgery. 2014; 96:778-88.