Non-Inferiority Seen with Subacromial Spacer for Rotator Cuff Tear vs Partial Repair

Orthopedics Today
21 Nov, 2020 ,

According to results presented at the American Shoulder and Elbow Surgeons Annual Meeting, use of a biodegradable subacromial implant spacer for massive rotator cuff tears had non-inferior outcomes to partial repair. “Non-inferiority was established in the intent-to-treat and patient populations for the study group,” Verma said. “InSpace realized an 11.4% mean advantage compared to the partial repair group.”

Source
Full content

Use of a biodegradable subacromial implant spacer for massive rotator cuff tears had non-inferior outcomes to partial repair, according to results presented at the American Shoulder and Elbow Surgeons Annual Meeting.

Nikhil N. Verma, MD, and colleagues randomly assigned patients with full-thickness massive rotator cuff tears and no prior surgical repair to treatment using either the InSpace biodegradable subacromial implant spacer (Stryker; n=93) or partial rotator cuff repair (n=91). Researchers collected Western Ontario Rotator Cuff score, American Shoulder and Elbow Surgeons Standard Shoulder Assessment and lack of device-related adverse events as a combined primary effective endpoint, while secondary endpoints included patient-reported outcomes, quality of life, VAS score and range of motion.

In his presentation, Verma noted no statistically significant differences in the primary composite endpoint between the groups.

“Non-inferiority was established in the intent-to-treat and patient populations for the study group,” Verma said. “InSpace realized an 11.4% mean advantage compared to the partial repair group.”

Although both groups had statistically significant improvements among various patient-reported outcome measures, Verma said patients in the InSpace group experienced early recovery of range of motion compared with the partial repair group.

“The InSpace group averaged about an 11-minute difference in terms of the time it took to perform the procedure in comparison to the partial repair group, offering an advantage to the InSpace implant,” Verma said. “With regard to complications, there were no differences between the groups.”