Non-inferiority seen with subacromial spacer for rotator cuff tear vs partial repair
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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.”
Perspective
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Samer S. Hasan, MD, PhD
The past 20 years have witnessed the proliferation of options for treating patients with symptomatic irreparable rotator cuff tears, including reverse shoulder arthroplasty, tendon transfer, superior capsule reconstruction and partial rotator cuff repair, with or without patch augmentation. The InSpace biodegradable subacromial implant spacer represents another potent arrow in the shoulder surgeon’s quiver.
Nikhil N. Verma, MD, and colleagues recently reported on the results of a 2-year multicenter randomized controlled clinical trial comparing the subacromial spacer and partial cuff repair. The authors demonstrated that the device can be deployed quickly, is safe to use and delivers a clinical result at least equivalent to that of a partial cuff repair. Although the study protocol specified similar physical therapy cadence for both study cohorts, patients receiving the spacer can initiate immediate active shoulder motion. Additionally, biomechanical studies have demonstrated that the subacromial spacer works as advertised. It centers the humeral head and optimizes deltoid function and shoulder kinematics. The device has been used since 2008 in Europe, where studies have demonstrated that clinical outcomes are maintained for at least 3 to 5 years, long after spacer degradation, likely because of deltoid and periscapular muscle retraining.
The clinical data related to the subacromial implant spacer study are currently under FDA review, and it is hoped that the device will be approved shortly for use in the United States. However, further comparative study will be needed to determine the precise indications for the subacromial implant spacer relative to the other treatment options for this challenging group of patients.
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Verma NN, et al. Balloon subacromial spacer vs. partial repair for massive rotator cuff tears: A randomized trial. Presented at: American Shoulder and Elbow Surgeons Annual Meeting; Oct. 2-3, 2020 (virtual meeting).
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