Data for a two-year trial of Stryker's InSpace subacromial balloon found the device was a viable option for patients with massive irreparable rotator cuff tears.
Five things to know:
1. The randomized study, published April 22 in the Journal of Bone and Joint Surgery, evaluated 184 patients. It compared Stryker's balloon implant with partial rotator cuff repair.
2. Patients were followed for two years. Eighty-three percent of patients who had the InSpace implant achieved the American Shoulder and Elbow Surgeons' minimally clinically important difference threshold, while 81% of the partial repair group reached that. Forward elevation was significantly greater in the InSpace group compared to the partial repair group as well.
3. There were no device-related surgical complications. Four reoperations were done after InSpace implantation and three after partial repair.
4. The study concluded, "The InSpace implant is an appropriate alternative to partial repair in patients with irreparable posterosuperior massive rotator cuff tears and an intact subscapularis. Notable benefits include early functional recovery and pain relief combined with a shorter operative time."
5. "These results demonstrating InSpace as a safe and effective option with earlier functional recovery, pain relief and shorter operative times are helping us change the game in shoulder surgery and creating better care for patients," the study's lead investigator, Nikhil Verma, MD, said in a May 3 news release.