Implantable Subacromial Balloon Spacers in Patients With Massive Irreparable Rotator Cuff Tears: A Systematic Review of Clinical, Biomechanical, and Financial Implications

Abstract

To determine the clinical, biomechanical, and financial impact of the use of subacromial balloon spacers in the surgical management of massive, irreparable rotator cuff tears (RCTs). Methods: All studies assessing the use of implantable subacromial balloon spacers for management of massive, irreparable RCTs were systematically searched. Risk of bias was assessed using Methodological Index for Non-Randomized Studies criteria. Data extraction and analysis was performed for pain and function scores, shoulder range of motion (ROM), glenohumeral contact pressure and vertical migration of humeral head, and cost. Subjective synthesis was performed with forest plots when outcomes were reported in 3 or more studies. Results: In total, 19 studies met inclusion criteria for analysis; 337 patients (mean age 68 years) had 343 subacromial balloon spacer implantations. Throughout a mean follow-up of 33 months, there was significant

Poor Results After Arthroscopic Treatment of Irreparable Rotator Cuff Tears Using a Subacromial Balloon Spacer

“…17 BSA reduced pressure and distributed it more evenly over repaired supraspinatus tendons in cadaveric studies, making it not only a stand-alone device for IRCTs but also an adjuvant therapy to tendon repair. 18 However, most of these nonclinical studies have conflicts of interest with the balloon manufacturer as noted by a recent review by Johns et al, 19 so they should be taken with caution and, as with any other medical device, we need to inspect the current clinical studies to get a more realistic picture.…”

Superior Capsular Reconstruction Using the Biceps Tendon in the Treatment of Irreparable Massive Rotator Cuff Tears Improves Patient-Reported Outcome Scores: A Systematic Review

“…Several treatment modalities have been described in the literature for their treatment. 2 , 5 , 8 , 10 , 25 Despite surgical repair of these massive retracted tears, a significant number of such repairs fail postoperatively. 19 Tendon retraction, fatty infiltration of the muscle, repair under tension, poor tissue vascularity, and insufficient length of the available tendon stump are some of the known causes of rotator cuff repair failure.…”

“…McLaughlin 18 described a similar procedure in 1944 using biceps tendon to augment repairs of irreparable RCTs. 8 Despite having been described long ago, this technique is not very popular because the biceps tendon is considered a pain generator. Pain in the biceps groove has not been reported as a long-term complication in any study.…”

“… 3 This results in pain, weakness, loss of range of motion (ROM), and pseudoparalysis, and in some patients, this may eventually lead to rotator cuff tear (RCT) arthropathy. 4 Several surgical procedures, including medialization of the rotator cuff footprint, 5 superior capsular reconstruction (SCR) using either tensor fascia lata (TFL) or human acellular dermis, 6 , 7 placement of implantable balloon spacers, 8 and reconstruction of the superior capsule using locally available biceps tendon, have been described as salvage procedures. 9 , 10 , 11 , 12 , 13 , 14 , 15 The common biomechanical principle in all these procedures is to restore the fulcrum and prevent proximal migration of the center of rotation of the glenohumeral joint.…”

Editorial Commentary: Mechanics Versus Biology: Both Are Relevant Principles in Understanding Superior Capsular Reconstruction

“…Ó 2021 by the Arthroscopy Association of North America 0749-8063/202062/$36.00 https://doi.org/10.1016/j.arthro.2020.12.227 appropriate control, and low levels of evidence," 10 and it remains to be seen how a device with a very limited life span can alter shoulder mechanics for more than a short period. It does appear that the physics demand that "thicker is better."…”