PDF(Pubmed)
Abstract：
OBJECTIVE: The purpose of the review is to provide an updated overview of a relatively novel but controversial surgical device (InSpace subacromial balloon, Stryker, Kalamazoo, MI) that can be readily incorporated into the armamentarium of the shoulder surgeon. The authors review the critical clinical and surgical decision-making aspects of InSpace. A recommended surgical technique and rehabilitation protocol are outlined. The authors present a nuanced view of the balloon spacer in the continuum of care of the irreparable rotator cuff tear.
RESULTS: Within the last year, two Level I clinical trials have been published, and the data from these studies offer conflicting evidence regarding the utility of the subacromial balloon spacer. The current review contrasts these two recent studies and offers a framework by which the available evidence can be practically understood with respect to clinical decision-making. The literature currently supports a limited indication for use of InSpace: the elderly, low-demand patient with preserved active range of motion with an operatively irreparable, posterosuperior rotator cuff tear with an intact subscapularis. The InSpace subacromial balloon spacer is a simple device that can yield substantial improvements in clinical outcomes among a subset of patients with irreparable rotator cuff tears. InSpace is not a panacea for the complex, irreparable rotator cuff tear. Individualized decision-making is necessary in this diverse and challening patient population.
RESULTS: Within the last year, two Level I clinical trials have been published, and the data from these studies offer conflicting evidence regarding the utility of the subacromial balloon spacer. The current review contrasts these two recent studies and offers a framework by which the available evidence can be practically understood with respect to clinical decision-making. The literature currently supports a limited indication for use of InSpace: the elderly, low-demand patient with preserved active range of motion with an operatively irreparable, posterosuperior rotator cuff tear with an intact subscapularis. The InSpace subacromial balloon spacer is a simple device that can yield substantial improvements in clinical outcomes among a subset of patients with irreparable rotator cuff tears. InSpace is not a panacea for the complex, irreparable rotator cuff tear. Individualized decision-making is necessary in this diverse and challening patient population.
摘要：
目的：评论的目的是提供一种相对新颖但有争议的手术装置（InSpace肩峰下球囊，史崔克,卡拉马祖,MI）可以很容易地结合到肩部外科医生的医疗设备中。作者回顾了InSpace的关键临床和手术决策方面。概述了推荐的手术技术和康复方案。作者介绍了球囊垫片在无法修复的肩袖撕裂的连续护理中的细微差别。
结果：去年，已经发表了两项I级临床试验，这些研究的数据提供了关于肩峰下球囊垫片实用性的相互矛盾的证据。当前的综述将这两项最新研究进行了对比，并提供了一个框架，通过该框架可以实际了解有关临床决策的可用证据。目前，文献支持使用InSpace的有限适应症：老年人，低需求的患者具有保留的活动范围，具有不可修复的手术，后上肩袖撕裂，肩胛骨下完整。InSpace肩峰下球囊间隔器是一种简单的装置，可以在不可修复的肩袖撕裂患者的子集中产生临床结果的实质性改善。InSpace不是复杂的灵丹妙药，无法修复的肩袖撕裂.在这个多样化且令人沮丧的患者群体中，个性化决策是必要的。
结果：去年，已经发表了两项I级临床试验，这些研究的数据提供了关于肩峰下球囊垫片实用性的相互矛盾的证据。当前的综述将这两项最新研究进行了对比，并提供了一个框架，通过该框架可以实际了解有关临床决策的可用证据。目前，文献支持使用InSpace的有限适应症：老年人，低需求的患者具有保留的活动范围，具有不可修复的手术，后上肩袖撕裂，肩胛骨下完整。InSpace肩峰下球囊间隔器是一种简单的装置，可以在不可修复的肩袖撕裂患者的子集中产生临床结果的实质性改善。InSpace不是复杂的灵丹妙药，无法修复的肩袖撕裂.在这个多样化且令人沮丧的患者群体中，个性化决策是必要的。
