The subacromial balloon spacer for massive irreparable rotator cuff tears: approximately 3 years of prospective follow-up.

backgroundIrreparable rotator cuff tears (RCT) are still a challenging problem. RCT can result in disability and severe pain. The optimal treatment for this disabling and painful diagnosis remains controversial. The arthroscopic implantation of a biodegradable subacromial balloon spacer is a possible treatment option. In this prospective study, we evaluate the clinical outcome of this balloon spacer after approximately 3 years.

methodsBetween March 2014 and December 2015, the biodegradable balloon spacer was implanted into the subacromial space of 46 shoulders of 44 patients with massive irreparable RCT. Pain was evaluated using a numeric rating scale (NRS), and functional outcome was evaluated using the Oxford shoulder score (OSS). Patients were followed prospectively for approximately 3 years. This present study focuses on the comparison between the early and the midterm results up to approximately 3 years.

resultsAll patients were treated by surgical implantation of the subacromial balloon spacer. The comparison between the outcomes of the NRS and the OSS after one and 3 years was made and showed no mutual significant differences, respectively, p = 0.61 and p = 0.08. Significant pain reduction and functional improvement was noticed postoperatively and maintained after approximately 3 years. At last follow-up (mean: 34 months), pain was reduced to a NRS of 3.09 points (95% CI: 2.17-4.01). Functional outcome based on the OSS improved significantly from 21.32 preoperatively to 34.39 (95% CI: 29.17-36.70) at the last follow-up. Correction for estimated confounders did not show significant differences. 82% of the patients were satisfied with the outcome after implantation of the subacromial balloon spacer. No surgical or postoperative medical complications due to implantation of the balloon spacer were reported.

conclusionsArthroscopic implantation of the biodegradable balloon spacer in the subacromial space is a safe and minimally invasive intervention. It leads to significant reduction in pain and significant improvement of functional daily activities in patients with irreparable RCT during 3 years of follow-up starting postoperative and maintain over time beyond device degradation. A high percentage of patients are satisfied postoperatively. Despite of these positive results after 3 years of follow-up, the specific contribution of the balloon needs further investigation.