Authors' objectives: To determine whether there is any evidence to support the efficacy and/or effectiveness of balloon spacers as treatment for massive rotator cuff tear (in particular for patients with previously failed surgical repair).

Authors' results and conclusions: After our initial search, twenty-two studies were deemed relevant (full appraisal and summaries in Table 1). The subacromial balloon spacer (a.k.a. InSpace? balloon implant) was first described in 2012 by Savarese and Romeo as treatment for massive irreparable rotator cuff tears and was initially approved for use in European Union countries and was recently (July 13, 2021) approved by the US Food and Drug Administration (FDA). This subacromial spacer, which is composed of a poly-lactide and e-caprolactone polymer, is implanted in the subacromial space (between the acromion and the humeral head) and then filled with saline, for the purpose of increasing, or normalizing, the distance between the humeral head and acromion, hence reducing the friction between the humeral head and acromion during abduction. The spacer eventually dissolves after 12 months. However, there is a report of failed degradation of an implanted subacromial balloon spacer causing a symptomatic foreign body reaction, which necessitated the subsequent surgical removal of the device. Longer periods of balloon degradation of up to 24 months have also been reported. The proposed benefit of this device seems to be twofold ? to facilitate smooth, frictionless articulation which would theoretically help restore the force couples of the remaining rotator cuff and deltoid, and aids in the healing of a repaired rotator cuff through a fibrous layer that is formed during its dissolution. However, its long-term mechanism of action remains uncertain; with regards to its limited duration, the exact mechanism explaining why pain and functional scores continue to improve beyond the period of spacer dissolution is also unclear, and the potential adverse effects associated with its use requires further investigation. It should also be noted that there are other treatment options available to patients with massive or irreparable rotator cuff tears reported in the literature which may be considered, especially for younger patients. At present, there is some short-term evidence on the effectiveness of InSpace? subacromial balloon spacer in improving function and reducing pain among patients diagnosed with massive or irreparable rotator cuff tears. However, this evidence needs to be interpreted with caution due to potential selection bias, conflict of interest, as well as the role of chance that cannot be excluded in interpreting the reported outcomes.

Authors' methods: Due to the limited information available to us with regards to balloon spacers, in order to develop our search strategy, we began our search by compiling for information on ?balloon spacer? as available via the internet search engine Bing?. We came across information on a device called the Stryker InSpace? balloon implant, described as a treatment option for massive irreparable rotator cuff tears. This search provided further information on the device we were investigating and thus informed our search strategy accordingly. A comprehensive and systematic search of commercial medical literature databases was conducted on February 17, 2022. Combinations of keywords were employed in this literature search. No limitations, such as on the date or language of publication were implemented in the literature search. A manual search on the references of the articles that were retrieved in full was also conducted.

Project Status: Completed

URL for project: https://www.worksafebc.com/en/about-us/research-services/evidence-based-medicine-and-systematic-reviews

Year Published: 2022

URL for published report: https://www.worksafebc.com/resources/health-care-providers/guides/balloon-spacer-treatment-massive-rotator-cuff-tear?lang=en

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Canada

Organisation Name: WorkSafeBC

Contact Address: 6591 Westminster Highway, Richmond, BC, V7C 1C6 Canada. Tel: 604-231-8417; Fax: 604-279-7698

Contact Name: ebpg@worksafebc.com

Contact Email: ebpg@worksafebc.com

Copyright: WorkSafe BC