Published: March 31, 2022 | Updated: July 31, 2023
A new procedure approved last year by the Food and Drug Administration is bringing relief to those experiencing massive rotator cuff tears. The Stryker InSpace subacromial balloon spacer is designed for patients who have a rotator cuff tear that is not directly repairable to bone but who are not ready for a reverse total shoulder replacement. This treatment is being offered by orthopedic surgeon and shoulder specialist Ryan J. Krupp, M.D., who is executive medical director of Norton Orthopedic Institute and Norton Sports Health. Dr. Krupp was the first to provide this service in the region.
The shoulder is a ball (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 motion, with the rotator cuff being the most significant of these structures. The rotator cuff is made of four muscles (supraspinatus, infraspinatus, subscapularis and teres minor) and their corresponding tendons that connect the humerus with the shoulder blade to keep the shoulder in place and provide the driving force for motion, such as lifting and rotating the arm.
Rotator cuff tears are common, especially as we age, with most tears occurring in patients over 40. When the muscles are damaged, irritated or torn, patients have pain, weakness and loss of mobility. Injuries like these often occur earlier in people who perform the same overhead motions repeatedly, often being seen in occupations like painters and carpenters. This is also a very common sports injury in “overhead” athletes, such as pitchers who overuse the “pitching arm,” or in weightlifters. Rotator cuff damage can accumulate over time, but tears also can occur after a traumatic event such as a fall or accident. Tears can be partial, where only part of the tendon is damaged, or full, where the tendon is completely separated from the bone.
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“In the case of a massive irreparable rotator cuff tear (MIRCT), the tendons have shrunk or pulled back, and thus there is inadequate tissue for a direct repair to the bone even with surgery,” Dr. Krupp said.
Pain and tenderness in the affected shoulder are the hallmark signs of rotator cuff injury, including when at rest or lying on the affected arm — especially with reaching overhead, behind the back or when pulling or lifting items. Patients typically experience shoulder weakness and loss of range of motion as well. When caused by trauma, such as lifting or falling on an outstretched arm, there may be sudden acute pain, a snapping sensation and immediate weakness. Symptoms also may develop gradually in more chronic situations, particularly with overhead repetitive activity. A partial or minor rotator cuff tear may get worse over time, especially if you don’t care for it properly.
Nonsurgical treatment may provide some relief of pain and allow for improved function. These treatments include rest and activity modification, strengthening exercises and physical therapy, and nonsteroidal anti-inflammatory drugs (NSAIDs) or steroid injections. If the pain and decreased function persist however, patients should consult with a shoulder specialist.
Fortunately, many rotator cuff tears can be repaired directly to the bone, restoring more normal anatomy and function, especially if addressed in a timely fashion.
“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 only of the deltoid but also the damaged rotator cuff,” Dr. Krupp said.
“The 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 do not have much arthritis and are not ready for a shoulder replacement.”
The InSpace balloon implant was designed with this patient population in mind. It allows for the arthroscopic treatment of MIRCT in patients who have the ability to compensate with their remaining rotator cuff and surrounding soft tissue structures and have minimal to no arthritis. The device is a biodegradable balloon that is inserted between the tip of the shoulder (called the acromion) and the humeral head, and then filled with saline. The balloon creates space between the bones and surrounding tissue, allowing for smoother motion and thus reducing friction and pain.
“It also restores the humeral head to a more normal position, allowing the remaining rotator tissue hopefully to adapt and work to stabilize and drive the shoulder,” Dr. Krupp said.
The implant does not last forever, resorbing over time beginning around three months with complete resorption in six to 12 months.
Per Dr. Krupp, “The theory is that as the implant resorbs, it gets replaced by scar tissue that serves as a buffer between the humeral head and acromion while at the same time allowing the patient to rehab the remaining rotator cuff tissue and other muscles around the shoulder.”
Potential advantages of this procedure compared with alternative treatments for MIRCT include:
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