Background: Massive rotator cuff tear (RCT) can result in disability and severe pain. When conservative treatment fails, surgical treatment should be considered, as various surgical options can provide relatively satisfactory results. However, choosing an optimal treatment remains controversial. A relatively new treatment for irreparable RCT is the arthroscopic implantation of a biodegradable balloon spacer into the subacromial space. Here, we examined whether placement of this balloon spacer reduces pain and improves functional outcome in patients with an irreparable RCT. Patients were followed for 1 year following implantation.
Methods: In this prospective single-arm study, a biodegradable balloon spacer was implanted into the subacromial space of patients with a massive RCT. Pain was evaluated using a numeric rating scale (NRS), and functional outcome was evaluated using the Oxford shoulder score (OSS) and the Constant-Murley shoulder score (CMS). Five follow-up visits were performed during the first postoperative year.
Results: Forty-six shoulders in 44 patients with massive RCT were treated by surgical implantation of the subacromial balloon spacer. The mean reduction in NRS score was 3.5 points (95% CI 2.5-4.4), and 74% of patients achieved the minimal clinically important difference of 2 points by the 1-year follow-up visit. Functional outcome improved significantly based on OSS and CMS scores, and 80% of patients reported that they were satisfied with their outcome. No surgical or postoperative medical complications due to implantation of the balloon spacer were reported.
Conclusions: Our results suggest that arthroscopic implantation of a biodegradable balloon spacer in the subacromial space significantly reduces pain and improves activities of daily living in patients with massive RCT during 1 year of follow-up. The specific contribution of the balloon with respect to improved clinical outcome needs further study, ideally in a randomized controlled trial.
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