FDA Approved Rotator Cuff Surgery Performed in Louisville


A new procedure approved last year by the Food and Drug Administration is bringing relief to those who suffer from massive rotator cuff tears. The Stryker InSpace Subacromial Balloon Spacer is designed for patients who have a rotator cuff tear that is not repairable directly to the bone but are not ready for a reverse total shoulder replacement . This treatment is offered by orthopedic surgeon and shoulder specialist Ryan J. Krupp, MD, Executive Medical Director of Norton Orthopedic Institute and Norton Sports Health. Dr. Krupp was the first to offer this service in the region.

What is the rotator cuff?

The shoulder is a ball and socket (humeral head) and socket (glenoid) joint, which is the most mobile joint in the body. It relies on the soft tissue structures around the shoulder for stability and movement, with the rotator cuff being the most important of these structures. The rotator cuff is made up of four muscles (supraspinatus, infraspinatus, subscapularis, and teres minor) and their corresponding tendons that connect the humerus to the scapula to hold the shoulder in place and provide the driving force for movement, such as arm lifting and rotation.

How can the rotator cuff be damaged?

Rotator cuff tears are common, especially with age, with most tears occurring in patients over 40 years of age. When muscles are damaged, irritated, or torn, patients experience pain, weakness, and loss of mobility. Injuries like these often occur earlier in people who perform the same overhead movements repeatedly, often seen in professions like painters and carpenters. It is also a very common sports injury in ‘overhead’ athletes, such as throwers who overuse the ‘throwing arm’ or weightlifters. Rotator cuff injuries can accumulate over time, but tears can also occur after a traumatic event such as a fall or accident. Tears can be partial, where only part of the tendon is damaged, or complete, where the tendon is completely separated from the bone.

Norton Orthopedic Institute

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“In the case of a massive irreparable rotator cuff tear (MIRCT), the tendons have shrunk or pulled away, and so there is no adequate tissue for direct bone repair, even with surgery,” Dr. Krupp said.

Signs of Rotator Cuff Injury and Treatments

Pain and tenderness in the affected shoulder are hallmark signs of a rotator cuff injury, including when resting or lying on the affected arm – especially when extending overhead, behind the back or when pulling or lifting objects. Patients typically suffer from shoulder weakness and loss of range of motion. When caused by trauma, such as lifting or falling on an outstretched arm, there may be sudden sharp pain, a snapping sensation, and immediate weakness. Symptoms can also develop gradually in more chronic situations, especially with repetitive overhead activity. A partial or minor rotator cuff tear can get worse over time, especially if you don’t take care of it properly.

Non-surgical treatment may provide some pain relief and allow for improvement in function. These treatments include rest and activity modification, strengthening exercises, and physical therapy, as well as nonsteroidal anti-inflammatory drugs (NSAIDs) or steroid injections. If pain and decreased function persist, patients should see a shoulder specialist.

New treatment for MIRCT

Fortunately, many rotator cuff tears can be repaired directly on the bone, restoring more normal anatomy and function, especially if treated in a timely manner.

“For massive irreparable rotator cuff tears (MIRCT), reverse total shoulder arthroplasty has become the primary treatment in these cases using the deltoid muscle to drive the shoulder and do the work not just of the deltoid but also from the damaged rotator cuff,” said Dr. Krupp.

“Reverse total shoulder replacement is a good option for many of our patients, but we are always looking for additional treatments to offer our patients, especially if they don’t have a lot of arthritis and are not ready for a shoulder replacement.”

The InSpace Balloon Implant was designed with this patient population in mind. It allows arthroscopic treatment of MIRCT in patients who have the ability to compensate with their remaining rotator cuff and surrounding soft tissue structures and who have little or no arthritis. The device is a biodegradable balloon that is inserted between the point of the shoulder (called the acromion) and the humeral head, then filled with saline solution. The ball creates space between the bones and surrounding tissues, allowing for smoother movement and reducing friction and pain.

“It also restores the humeral head to a more normal position, hopefully allowing the remaining rotator tissue to adapt and work to stabilize and drive the shoulder,” Dr. Krupp said.

The implant does not last forever, resorbing over time starting around three months with full resorption in six to 12 months.

According to Dr. Krupp, “The theory is that as the implant resolves, it is replaced by scar tissue which acts as a buffer between the humeral head and the acromion while allowing the patient to rehabilitate the remaining rotator cuff tissue. rotators and other muscles around the shoulder.

Potential advantages of this procedure over alternative treatments for MIRCT include:

  • Shorter surgical time
  • Less invasive approach
  • Quicker return to activity
  • Shorter and less complex rehabilitation protocol


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