Clinical trial evaluates unique treatment option for advanced rotator cuff tears

INSPACE IS A GAME CHANGER

Clinical Trial Evaluates Unique, Less Invasive, Treatment Option for Advanced Rotator Cuff Tears

By Brian Sodoma

Rotator cuff tears are a common shoulder problem, but they also present to physicians with a wide range of severity. Rotator cuff repair enjoys a high success rate for younger adults with smaller tears. On the other hand, due to poorer tissue quality and slower healing, older patients with larger tears may not enjoy the same benefits. A shoulder replacement has typically been the alternative if a repair is unlikely to succeed.

But that could all change soon for many active older adults. The CORE

Institute and MORE Foundation have partnered to investigate an innovative procedure called InSpace, which could bring promise as a new option for many who need it.

Dr. Marc Jacofsky

RESTORING ROTATOR CUFF FUNCTION

A massive rotator cuff tear, which involves at least two or more of the four tendons in the region, is the most severe tear, and a particular problem for a wide range of older adults, explained Dr. Michael Amini, The CORE Institute’s chief surgeon in its Shoulder & Sports Division and Principal Investigator for the study.

Developed by Stryker Sports Medicine, InSpace places a saline-filled balloon above the shoulder bone to serve much like a “pillow” in place of the rotator cuff. It reduces pain and improves function by limiting unwanted movement of the shoulder and preventing impingement. The balloon dissolves in about a year, but with less stress on the muscles, they become stronger and operate efficiently together on their own to offer improved comfort and motion again. “When we heard this was coming to the U.S., we wanted to be an early adopter. InSpace has the potential to fill a gap in care, and it’s without a doubt the least invasive option with a shorter path to recovery,” Dr. Amini added.

The procedure has been performed more than 30,000 times in Europe over the last decade, Dr. Amini noted. It has been used in the United States since the summer of 2021, and surgeons at The CORE Institute were the first in Arizona, and among the first few in the country, to use it.

EVALUATING REHABILITATION

Accelerating recovery is indeed the greatest potential benefit of InSpace. The shoulder can be used within two weeks, whereas traditional replacement or repair usually requires the arm to stay in a sling for six to 12 weeks, Dr. Amini emphasized.

With the help of the MORE Foundation, the study will monitor data from 150 patients 65 years or older enrolled across eight sites around the U.S., one of them being The CORE Institute. Two rapid rehabilitation programs will be analyzed for quality of outcomes: one is guided by a physical therapist, the second is a homebased protocol, both with the same exercises and recovery timeline.