Fluoroscopically Guided Subacromial Spacer Implantation for Massive Rotator Cuff Tears: Two Years of Prospective Follow-up.

Background: Massive rotator cuff tears (MRCTs) are common and have been estimated to account for nearly 40% of all rotator cuff tears. An evolving strategy for management of MRCTs has been the implantation of a degradable subacromial spacer balloon that attempts to restore normal shoulder biomechanics.
Purpose: To assess the safety and efficacy of fluoroscopically guided balloon spacer implantation under local anesthesia in a cohort of patients with 2 years of postoperative follow-up.
Study Design: Case series; Level of evidence, 4.
Methods: The safety and efficacy of using fluoroscopically guided subacromial spacer implantation was assessed in 46 patients. Follow-up visits were scheduled according to routine clinical practice. Shoulder function was evaluated using Constant and American Shoulder and Elbow Society (ASES) scores.
Results: Overall, 87.5% (35/40) of patients saw clinically significant improvement in the total Constant and ASES scores from 6 weeks postoperatively, with improvement maintained up to 24 months postoperatively.
Conclusion: The data suggest that fluoroscopically guided subacromial spacer implantation under local anesthesia is a low-risk, clinically effective option, especially for the elderly population and those patients who have multiple comorbidities or a contraindication to general anesthesia. Patients undergoing subacromial spacer implantation for the treatment of MRCTs had satisfactory outcomes at 2-year follow-up, with a low rate of complications.
Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: Devices for the surgical procedures in this study were provided by OrthoSpace. E. Maman is a paid consultant and member of the scientific advisory team for OrthoSpace and has stock options in OrthoSpace. A.D. is co-founder and medical director of OrthoSpace. E. Markovitz is an employee of OrthoSpace. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.
(© The Author(s) 2021.)