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Orthop J Sports Med. 2019 Oct 15;7(10):2325967119875717. doi: 10.1177/2325967119875717. eCollection 2019 Oct.

Outcomes of Subacromial Balloon Spacer Implantation for Massive and Irreparable Rotator Cuff Tears: A Systematic Review.

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1
Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
2
Medical College of Georgia at Augusta University, Augusta, Georgia, USA.
3
Rush University Medical Center, Chicago, Illinois, USA.

Abstract

Background:

Selection of optimal treatment for massive to irreparable rotator cuff tears (RCTs) entails a challenging decision-making process in which surgeons must consider several factors, including duration of symptoms, tear pattern, tear size, and muscle quality, as well as patient characteristics such as age, comorbidities, shoulder dominance, and activity level. Unfortunately, no clear consensus has been reached regarding optimal management.

Purpose:

To systematically review the published literature assessing outcomes after subacromial balloon spacer implantation for treatment of massive and irreparable RCTs.

Study Design:

Systematic review; Level of evidence, 4.

Methods:

A comprehensive literature search was performed in September 2018 through use of MEDLINE and the Cochrane Library electronic databases. Studies were assessed for multiple outcomes of interest including Constant score, Oxford Shoulder Score (OSS), University of California Los Angeles (UCLA) Shoulder Score, complications, and patient satisfaction.

Results:

After applying the selection criteria, 12 clinical studies were included for data extraction and analysis. In total, 291 shoulders (in 284 patients) treated with subacromial balloon spacer implantation were pooled for evaluation, with a mean follow-up of 22.9 ± 14.9 months (range, 6-60 months). Constant scores were used as an outcome metric for 267 shoulders (91.7%; 11 studies), with improvements in mean Constant score ranging from 18.5 to 49.6 points. Patient satisfaction was assessed in 105 patients (37.0%; 5 studies), with rates of patients indicating they were satisfied or very satisfied with their treatment outcome ranging from 45.8% to 100%. A total of 6 patients (2.1%) experienced complications related to balloon spacer implantation, including transient neurapraxia of the lateral antebrachial cutaneous nerve, superficial wound infection, deep wound infection, and balloon migration. Of these, 3 patients (2 balloon migration, 1 deep wound infection) required subsequent surgeries for balloon removal.

Conclusion:

Placement of the subacromial balloon spacer is a minimally invasive, technically simple procedure with favorable patient-reported outcomes at limited short-term follow-up. However, inherent methodological limitations and patient heterogeneity between studies may impair our ability to fully characterize the longer term efficacy, particularly relative to other potential surgical options. Further prospective randomized or comparative studies are warranted to ascertain clinical outcomes of subacromial balloon spacer in the management of massive and irreparable RCTs.

KEYWORDS:

Shoulder; rotator cuff; shoulder biomechanics; subacromial balloon

Conflict of interest statement

One or more of the authors has declared the following potential conflict of interest or source of funding: S.A.P. has received research support from Exactech, consultant fees from Arthrex and Exactech, and hospitality payments from Smith & Nephew and Stryker. B.R.G. has received research support from Southtech Orthopedics, educational support and consultant fees from Mitek, and hospitality payments from Exactech. N.N.V. has received research support from Arthrex, Breg, Ossur, Smith & Nephew, and Wright Medical; consultant fees from Medacta, Minivasive, and Orthospace; royalties from Smith & Nephew and Vindico Medical-Orthopedics Hyperguide; educational support from Medwest; and nonconsulting fees from Pacira Pharmaceuticals and has stock/stock options in Cymedica, Minivasive, and Omeros. B.R.W. has received research support from Arthrex, royalties from Elsevier, speaking fees from Genzyme, educational support from Smith & Nephew, and hospitality payments from Medical Device Business Systems. 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.

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