TY - JOUR
T1 - Subacromial Balloon Spacer for Massive, Irreparable Rotator Cuff Tears Is Associated With Improved Shoulder Function and High Patient Satisfaction
AU - Familiari, Filippo
AU - Nayar, Suresh K.
AU - Russo, Raffaella
AU - De Gori, Marco
AU - Ranuccio, Francesco
AU - Mastroianni, Valerio
AU - Giuzio, Ermes
AU - Galasso, Olimpio
AU - Gasparini, Giorgio
AU - McFarland, Edward G.
AU - Srikumaran, Uma
N1 - Funding Information:
The authors report the following potential conflicts of interest or sources of funding: Funding was provided by a grant (Borsa di Studio "L. Perugia") from the Italian Shoulder and Elbow Society (Società Italiana di Chirurgia della Spalla e del Gomito). U.S. receives personal fees (stock equity/options) from Tigon Medical, outside the submitted work; receives personal fees from Conventus, Fx Shoulder USA, Orthofix, Smith & Nephew, Heron, and Pacira, outside the submitted work; and receives grant support from DePuy Synthes, Arthrex , Wright, Smith & Nephew, American Shoulder and Elbow Surgeons , and OMEGA, outside the submitted work. In addition, U.S. has patents pending with Conventus, Fx Shoulder USA, and Tigon Medical. Full ICMJE author disclosure forms are available for this article online, as supplementary material .
Funding Information:
The authors report the following potential conflicts of interest or sources of funding: Funding was provided by a grant (Borsa di Studio ?L. Perugia?) from the Italian Shoulder and Elbow Society (Societ? Italiana di Chirurgia della Spalla e del Gomito). U.S. receives personal fees (stock equity/options) from Tigon Medical, outside the submitted work; receives personal fees from Conventus, Fx Shoulder USA, Orthofix, Smith & Nephew, Heron, and Pacira, outside the submitted work; and receives grant support from DePuy Synthes, Arthrex, Wright, Smith & Nephew, American Shoulder and Elbow Surgeons, and OMEGA, outside the submitted work. In addition, U.S. has patents pending with Conventus, Fx Shoulder USA, and Tigon Medical. Full ICMJE author disclosure forms are available for this article online, as supplementary material.
Publisher Copyright:
© 2020 Arthroscopy Association of North America
PY - 2021/2
Y1 - 2021/2
N2 - Purpose: To investigate associations between clinical and demographic parameters and Constant-Murley (CM) scores after subacromial balloon placement for massive, irreparable rotator cuff tears and to evaluate implant survival, shoulder function, and patient satisfaction. Methods: We prospectively analyzed patients with rotator cuff tears deemed irreparable on preoperative magnetic resonance imaging for whom nonoperative therapy was unsuccessful and who underwent balloon placement from 2014 to 2017 with minimum 1-year follow-up. Shoulder function was assessed using the CM score and the 12-Item Short Form Health Survey. Results: The study included 51 patients (22 women and 29 men) with a mean age at surgery of 63 years (range, 50-78 years). The mean follow-up period was 36 months (range, 24-56 months). The postoperative acromiohumeral interval and total preoperative CM score predicted the postoperative CM score at final follow-up. The implant survival rates were 92% at 6 and 12 months, 90% at 2 years, and 87% at 3 and 4 years. Five patients underwent reverse total shoulder arthroplasty, and 1 underwent latissimus dorsi tendon transfer. Postoperatively, mean CM scores (± standard deviation) improved for range of motion (from 11 ± 5.4 to 34 ± 6.8) and strength (from 13 ± 5.4 to 28 ± 12) (P < .01 for both). The total CM score improved from 27 ± 7.4 preoperatively to 77 ± 15 postoperatively (P < .01). The physical and mental component summary scores on the 12-Item Short Form Health Survey improved from 27 ± 5.0 to 51 ± 6.5 (P = .02) and from 44 ± 15 to 56 ± 8.0, respectively (P < .01). Thirty-eight patients reported excellent satisfaction, 8 were satisfied, and 5 were dissatisfied. Of the patients, 50 (98%) exceeded the minimal clinically important difference (≥10.4) and patient acceptable symptom state (≥44). Conclusions: At mean 3-year follow-up, subacromial balloon spacer placement for massive, irreparable rotator cuff tears was associated with a significant improvement in shoulder function, limited need for revision surgery, and high patient satisfaction. A greater postoperative acromiohumeral interval and lower preoperative CM score predicted a lower postoperative CM score at final follow-up. Level of Evidence: Level IV, retrospective cohort study and treatment study.
AB - Purpose: To investigate associations between clinical and demographic parameters and Constant-Murley (CM) scores after subacromial balloon placement for massive, irreparable rotator cuff tears and to evaluate implant survival, shoulder function, and patient satisfaction. Methods: We prospectively analyzed patients with rotator cuff tears deemed irreparable on preoperative magnetic resonance imaging for whom nonoperative therapy was unsuccessful and who underwent balloon placement from 2014 to 2017 with minimum 1-year follow-up. Shoulder function was assessed using the CM score and the 12-Item Short Form Health Survey. Results: The study included 51 patients (22 women and 29 men) with a mean age at surgery of 63 years (range, 50-78 years). The mean follow-up period was 36 months (range, 24-56 months). The postoperative acromiohumeral interval and total preoperative CM score predicted the postoperative CM score at final follow-up. The implant survival rates were 92% at 6 and 12 months, 90% at 2 years, and 87% at 3 and 4 years. Five patients underwent reverse total shoulder arthroplasty, and 1 underwent latissimus dorsi tendon transfer. Postoperatively, mean CM scores (± standard deviation) improved for range of motion (from 11 ± 5.4 to 34 ± 6.8) and strength (from 13 ± 5.4 to 28 ± 12) (P < .01 for both). The total CM score improved from 27 ± 7.4 preoperatively to 77 ± 15 postoperatively (P < .01). The physical and mental component summary scores on the 12-Item Short Form Health Survey improved from 27 ± 5.0 to 51 ± 6.5 (P = .02) and from 44 ± 15 to 56 ± 8.0, respectively (P < .01). Thirty-eight patients reported excellent satisfaction, 8 were satisfied, and 5 were dissatisfied. Of the patients, 50 (98%) exceeded the minimal clinically important difference (≥10.4) and patient acceptable symptom state (≥44). Conclusions: At mean 3-year follow-up, subacromial balloon spacer placement for massive, irreparable rotator cuff tears was associated with a significant improvement in shoulder function, limited need for revision surgery, and high patient satisfaction. A greater postoperative acromiohumeral interval and lower preoperative CM score predicted a lower postoperative CM score at final follow-up. Level of Evidence: Level IV, retrospective cohort study and treatment study.
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U2 - 10.1016/j.arthro.2020.09.048
DO - 10.1016/j.arthro.2020.09.048
M3 - Article
C2 - 33068742
AN - SCOPUS:85096489357
SN - 0749-8063
VL - 37
SP - 480
EP - 486
JO - Arthroscopy - Journal of Arthroscopic and Related Surgery
JF - Arthroscopy - Journal of Arthroscopic and Related Surgery
IS - 2
ER -