I recently published a detailed opinion piece in the Journal of Orthopaedic Experience & Innovation on the InSpace balloon.
You can read the full peer-reviewed article on the journal’s website here: From My Perspective…InSpace Balloon: Real Solution? Below is a summary of what I found and why it matters for my patients.
What Is the InSpace Balloon?
The InSpace balloon is a bioabsorbable device placed in the subacromial space of the shoulder. Surgeons implant it during a quick arthroscopic procedure. It dissolves on its own after about six months. The FDA approved it in 2021 as a treatment for irreparable rotator cuff tears.
How I Got Involved With the Trial
I first heard about the balloon from a colleague, Dr. Michael McKee, during a visit to the University at Buffalo Orthopedic Department. I later learned my own mentor, Dr. Laith Jazrawi, was already part of the FDA trial studying the device. That connection led our site to join the study.
We enrolled six patients, half of whom received the balloon. Both groups improved overall. One patient who got the balloon told me the benefit faded within a year. One who did not get it called his surgery the best decision he ever made and returned to work as a tree cutter.
Since the trial ended, I have placed only two more balloons. Both patients specifically requested the device.
What the Research Actually Shows
My own experience is too small to draw conclusions from alone. That is why the published data matters more.
Two Major Studies, One Ongoing Debate
Two randomized controlled trials looked closely at the InSpace balloon. The FDA IDE trial was published in the Journal of Bone and Joint Surgery. A separate trial, called START:REACTS, was published in The Lancet. Neither trial found a meaningful difference in patient outcomes between balloon and non-balloon treatment after one year. START:REACTS actually suggested a possible negative effect, though it did not reach the threshold considered clinically significant.
The two studies disagreed on some technical points, including how patients with partial tears of the subscapularis tendon were included, and how range of motion was measured. After reviewing both papers and corresponding directly with the lead author of START:REACTS, I found the criticism of that trial’s design did not hold up well under scrutiny.
A Flaw in the FDA Trial’s Design
The FDA IDE trial had a design limitation the other study avoided. Its control group received a partial rotator cuff repair in addition to skipping the balloon, which changed two variables at once instead of one. That makes it harder to know whether the balloon itself, or the added repair, explains any difference in results. START:REACTS isolated a single variable, the balloon, making its comparison more reliable from a research standpoint.
Why Value Matters as Much as Outcomes
The InSpace balloon costs between five and seven thousand dollars per implant, similar to many reverse total shoulder replacement devices. When neither major trial showed a clear long-term functional benefit over simple debridement, that price becomes difficult to justify. Value in medicine should weigh outcomes against cost, not outcomes alone.
My Recommendation for Patients Today
The InSpace balloon appears to be a safe option for patients with irreparable superior rotator cuff tears. But safety alone does not make it the right choice. Based on the strongest available evidence, I do not see it outperforming arthroscopic debridement, with or without partial repair. I only consider placing the balloon for patients who specifically seek it out, and I make sure they understand what the data does and does not show first.
As a Clinical Associate Professor at the University at Buffalo Jacobs School of Medicine, staying current with research like this shapes how I counsel every patient who comes through my Buffalo-area offices with a rotator cuff tear.
For a closer look at how this fits with other rotator cuff treatment options, see my earlier posts on the balloon implant for irreparable rotator cuff tears and the balloon spacer discussion, or learn more about rotator cuff tear treatment options.
To read the complete peer-reviewed article, including the full study comparison table and references, visit the Journal of Orthopaedic Experience & Innovation.