Subacromial balloon spacer seen as safe, effective for patients with rotator cuff tears
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Results showed a subacromial balloon spacer provided early functional recovery and pain relief with shorter operative times compared with arthroscopic partial repair in patients with irreparable, posterosuperior massive rotator cuff tears.
Nikhil N. Verma, MD, and colleagues analyzed 184 patients with symptomatic, irreparable, posterosuperior massive rotator cuff tears and an intact subscapularis who underwent failed nonoperative management. According to the study, 93 patients were randomized to receive a subacromial balloon spacer (InSpace implant; Stryker), while 91 patients were randomized to arthroscopic partial repair.
Outcome measures were collected from baseline to 2-year follow-up and included the American Shoulder and Elbow Surgeons (ASES) score, Western Ontario Rotator Cuff score, VAS pain score, Constant-Murley shoulder score, EuroQol-5D 5-Level score, range of motion, operative time, complications and reoperations.
Verma and colleagues found a significant and clinically relevant improvement in ASES scores from baseline to 1-year and 2-year follow-up for patients who received the balloon spacer. Among the balloon spacer cohort, 83% of patients achieved the ASES minimally clinically important difference threshold and 82% of patients achieved the substantial clinical benefit threshold. Among the partial repair cohort, 81% of patients achieved the ASES minimally clinically important difference threshold and 79% of patients achieved the substantial clinical benefit threshold.
Mean operative time was 44.6 minutes for the balloon spacer cohort and was 71.2 minutes for the partial repair cohort. Researchers found no device-related surgical complications; however, four reoperations were required in the balloon spacer cohort and three reoperations were required in the partial repair cohort.
“The InSpace implant is an appropriate alternative to partial repair in patients with irreparable posterosuperior massive rotator cuff tears and an intact subscapularis,” researchers wrote in the study. “Notable benefits include early functional recovery and pain relief combined with a shorter operative time,” they added.
Perspective
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Clinical experience with the InSpace subacromial balloon spacer outside North America exceeds a decade and several published studies have demonstrated safety and improved clinical outcomes maintained for up to 5 years. However, high-level clinical study of the subacromial balloon spacer had been lacking until the recent article by Verma and colleagues summarizing the results of a pivotal, multicenter, randomized clinical trial.
Twenty sites throughout the United States and Canada enrolled patients in this robust level-1 study, comparing the outcomes following subacromial balloon spacer subacromial balloon spacer vs. partial rotator cuff repair. Both cohorts were characterized by nearly identical demographics and distribution of ancillary procedures, and a remarkable subject retention approaching 90%.
The study demonstrated noninferiority of the subacromial balloon spacer relative to partial rotator cuff repair. Additionally, subacromial balloon spacer insertion time averaged 4 minutes and the procedure was uniformly safe, with no device related complications. More importantly, patients receiving a subacromial balloon spacer demonstrated faster recovery of comfort and active motion than following partial repair, despite identical immobilization and rehabilitation protocols to maintain subject blinding.
The InSpace subacromial balloon spacer, approved by the FDA for clinical use in July 2021, represents an important arrow in our quiver of treatment options for the patients with a symptomatic massive, irreparable rotator cuff tear, but without advanced glenohumeral arthritis or pseudoparalysis. Further comparative study is needed to determine the precise role for the subacromial balloon spacer relative to other treatment options, such as superior capsule reconstruction, tendon transfers and reverse shoulder arthroplasty, and the optimal cadence for postoperative recovery.
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