*Note: this device is not yet available in the US.
It seems incredibly rare for someone to dream up a completely novel treatment for a complex, challenging orthopedic problem and have that treatment be less invasive, less risky to the patient, cost less than the accepted existing standard treatments, and provide excellent results with little downside. Read below to find out about one such case.
There is a new device that is being utilized in Europe and Israel (currently not approved by the US FDA and not available for sale in the US) to treat patients with massive, irreparable rotator cuff tears. Clinical trials are currently underway in the US with the hope that FDA approval will be forthcoming. This device is the InSpace balloon. I learned about this new device while attending a recent international conference on shoulder surgery; I have no affiliation with the device or its inventors/owners, I just think it sounds incredibly innovative, promising, and brilliant and I really wish I had thought of it :).
Some massive rotator cuff tears, due to poor tendon and muscle quality, will not allow a successful rotator cuff repair. The optimal treatment for massive rotator cuff tears is debated. There are many treatment options, all with their own risks and benefits. The exact choice of treatment depends on the patient’s problems, age, functional requirements and the surgeons’s preferences and experience. One recent development is the InSpace balloon. It is a low risk procedure and may have some benefits over traditional treatments.
The InSpace device is composed of an introducer and a balloon-shaped spacer made of a biodegradable polymer which is a widely used material in the medical industry. The spacer is positioned by an arthroscopic procedure in the subacromial space between the humeral head and the acromion. Once positioned, the spacer is inflated with physiological water to allow smooth and frictionless gliding between the shoulder bones (see the images below showing the position of the implanted balloon in relation to the bones and muscles).
As pain associated with the torn rotator cuff tendons may cause abnormal motion and limit rehabilitation, breaking the pain cycle may facilitate successful rehabilitation, allow pain relief, improve shoulder function, and potentially eliminate or defer the need for more extensive shoulder surgery. The spacer degrades within 6-12 months. While the spacer is intact in the shoulder, the patient proceeds with focused rehab, working to retrain their muscles to move the shoulder in such a way that pain is diminished and hopefully eliminated and function is optimized.
Some patients develop massive rotator cuff tears slowly over time and they are able to adjust their shoulder musculature to function much like an intact rotator cuff; centering the humeral head and powering the shoulder at the same time. These patients have remarkably painless and functional shoulders. The balloon gives the patient with a massive cuff tear who hasn't been able to compensate on his/her own the time to do so with the balloon doing the work of centering the head while the shoulder muscles retrain.
The InSpace Balloon is intended to decrease pain associated with ruptured tendons following a rotator cuff tear. It has been approved by the European authorities since July 2010.
The surgical procedure of InSpace balloon insertion is similar to other routine rotator cuff surgeries, conducted in an operating room, under general or regional anaesthesia using an arthroscopic approach.
European and Israeli surgeons are using InSpace in two situations: to buy several more years’ time for patients facing shoulder replacement surgery; and for patients with massive rotator cuff tears that cannot successfully be fixed surgically.
Through arthroscopy or mini-open surgery, InSpace can be implanted in under 10 minutes.
Dr. Chezar Avi from Emek Medical Center in Afula has implanted the device in patients with large unreparable tears causing significant pain, and in older patients seeking to avoid joint replacement surgery: “The biggest advantage is that the procedure is simple, done arthroscopically and the recovery is fast and fairly easy,” reports the surgeon. “Another advantage is that if it fails, you can always return and perform joint replacement surgery in the future.”
Clinical data collected by the device's parent company, OrthoSpace shows that approximately 85 percent of patients experience improvement in shoulder function after implantation, and that improvement gets better over time.
Clinical trials are currently underway in the US.
This information is provided as an educational service and is not intended to serve as medical advice. Anyone seeking specific orthopaedic advice or assistance should consult his or her orthopaedic surgeon.
Sara Jurek, MD