Abstract
Massive irreparable rotator cuff tears (MIRCTs) represent a difficult situation especially in painful and pseudoparalytic patients. A new technique, consisting of an arthroscopic implantation of an inflatable biodegradable “balloon”, serving as a temporary subacromial spacer, has been introduced recently for MIRCTs. The purpose of this paper is: 1) to present the efficacy and safety results of patients treated with the balloon; 2) to show that these results are maintained over time, after balloon degradation; 3) to compare these results to published results of other procedures available for MIRCTs.
This paper presents the first group of 22 patients (females/males 13/8, one bilateral), treated in a single-surgeon, prospective and on-going series of 97 shoulders operated with the balloon, since September 2010. The mean age is 69.3 (52–86) and the average follow-up 52.5 months. The balloon is inserted arthroscopically and inflated with saline. The procedure is simple with a short operative time (10–20 min). It can also supplement partial repairs, especially of the subscapularis, as well as repairable massive tears with bad tissue quality. The balloon is not used in severe cuff tear arthropathy or complete insufficiency of the external rotators. Final outcome scores, Constant (CS) and UCLA scores are obtained at least three years after complete balloon degradation (which occurs within 12 months), and are also compared to those of other treatments available for MIRCTs.
No device related safety issues were observed in this group. Good results, including rapid pain relief and restoration of active motion, which maintained over time, are obtained in 85% of the patients. The CS has improved significantly (average preop/postop: pain 2.9/12.7; ADL 6.8/17.4; ROM 22.8/36.6; strength 3.1/5.6; TOTAL 35.8/72.3; NORMATIVE 42.7/86.4). The UCLA score has also improved significantly (preop/postop: pain 1.9/8.6; function 3.9/8.6; active flexion 3.5/4.5; strength in flexion 2.4/3.4; satisfaction 0/4.5; TOTAL 11.2/29.8). Pseudoparalysis is reversed (average preop/postop flexion 86°/156.8°). The CS and UCLA score for the balloon are superior compared to published results of debridement, biceps tenotomy/tenodesis, partial repair, tuberoplasty and latissimus dorsi transfer. CS (86.4/63.8), CS pain (12.7/11.9) and flexion (156.8/128.0) are also better for the balloon compared to the reverse prosthesis.
The balloon is indicated for MIRCTs, as well as reparable massive tears with a high risk of retear. The implantation is a straightforward and short procedure, which has excellent safety profile and positive effect on painful MIRCTs including pseudoparalysis. The balloon provides significant improvement in the CS and UCLA score that persists way beyond its degradation. The balloon patients' shoulder function is superior to the other available treatment options. Additional studies are needed to further confirm the effectiveness of the balloon as a first line treatment for MIRCTs.
