Satisfactory mid-term outcome of subacromial balloon spacer for the treatment of irreparable rotator cuff tears
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To answer the question whether arthroscopic subacromial balloon spacer (InSpace Balloon—ISB) implantation results in improved outcomes in patients suffering by irreparable massive rotator cuff tears (MRCT). Secondarily, we aimed to compare the outcomes of a combined ISB and arthroscopic partial repair procedure with those of a single ISB implantation without any repair.
A retrospective single-centre case series, based on prospectively collected data of patients who were suffering by irreparable MRCT, was conducted. An ISB implantation along with an arthroscopic non-anatomic repair or debridement was carried out in all patients included in this study. Patients were functionally evaluated with the use of the American Shoulder and Elbow Surgeons Shoulder Score and the Constant score. Individual’s pain was pre- and postoperatively measured with the Visual Analogue Scale (0–100/100). Patients’ satisfaction and postoperative complications were also documented. As for the active range of motion (RoM), shoulder’s forward flexion, external rotation at 0° and of 90° of abduction, and internal rotation were also pre- and postoperatively assessed.
Thirty-one patients [mean age: 65.2 years, standard deviation (SD): 8.5, and range: 50–80 years] with a mean follow-up of 22.1 months (SD: 9.8; range: 6–31 months) were reviewed. All final postoperative clinical and functional scores were significantly improved in comparison with the preoperative values (p < 0.05). The vast majority of the patients declared fully or almost fully satisfied with their treatment (80.6%), while most patients were free of pain at their last follow-up (83.9%). We identified 18 patients (group A), who were treated with a combined ISB implantation and arthroscopic non-anatomic repair and 13 patients (group B) who received an ISB implant without any repair. The long head of biceps, where existed, was tenotomized in both groups. No significant difference was found between the baseline demographic and clinical characteristics of the two groups. As for the mean final postoperative scores and RoM, the differences between the two groups were insignificant (p > 0.05).
The use of ISB implantation for patients suffering by MRCT leads to significantly improved mid-term outcomes and high patents’ satisfaction. The additional use of arthroscopic partial repair with ISB was not proven superior to the single ISB implantation.
Level of evidence
IV; therapeutic case series.
KeywordsIrreparable massive rotator cuff tears Subacromial biodegradable spacer Balloon Arthroscopic partial repair Arthroscopic debridement Shoulder arthroscopy Shoulder retrospective case series
The authors wish to thank Dr. Crysanthi Papanastasopoulou for her valuable contribution to the statistical part of the study.
MM wrote the manuscript, and participated in the conception and design of the study and in the interpretation of data. EB critically revised and edited the manuscript, participated in the acquisition of data, and assisted during the operations. MM and EB have contributed equally to this work (EB should be considered as second–first author). GA critically revised the manuscript, participated in the acquisition of data and assisted during the operations. EA carried out all the operations and had the final checking of the manuscript. All authors read and approved the final manuscript.
Compliance with ethical standards
Conflict of interest
MM, EB, and GA declare that they have no competing interests. EA has received honoraria from Orthospace LTD.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee (HYGEIA Hospital, Athens, Greece; IRB number: 02/05/2018) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.