Skip to main content

Advertisement

SpringerLink
Log in

Subacromial Balloon Spacer for the Massive Irreparable Cuff Tear

  • Published:
Current Reviews in Musculoskeletal Medicine Aims and scope Submit manuscript

  • 3 Altmetric

Abstract

Purpose of Review

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.

Recent Findings

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.

Summary

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. Matsen FA, Cordasco FA, Sperling JW, Lippitt SB. Rockwood and Matsen’s The Shoulder E-Book: Rockwood and Matsen’s The Shoulder E-Book. Elsevier Health Sciences; 2021.

  2. Sheean AJ, Hartzler RU, Denard PJ, et al. Preoperative radiographic risk factors for incomplete arthroscopic supraspinatus tendon repair in massive rotator cuff tears. Arthroscopy. 2017. https://doi.org/10.1016/j.arthro.2017.09.046.

    Article  PubMed  Google Scholar 

  3. Kim SJ, Kim SH, Lee SK, Seo JW, Chun YM. Arthroscopic repair of massive contracted rotator cuff tears: aggressive release with anterior and posterior interval slides do not improve cuff healing and integrity. J Bone Joint Surg Am. 2013;95(16):1482–8. https://doi.org/10.2106/JBJS.L.01193.

    Article  PubMed  Google Scholar 

  4. Minagawa H, Yamamoto N, Abe H, et al. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: from mass-screening in one village. J Orthop. 2013;10(1):8–12. https://doi.org/10.1016/j.jor.2013.01.008.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Yamamoto A, Takagishi K, Osawa T, et al. Prevalence and risk factors of a rotator cuff tear in the general population. J Shoulder Elbow Surg. 2010;19(1):116–20. https://doi.org/10.1016/j.jse.2009.04.006.

    Article  PubMed  Google Scholar 

  6. Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. a long-term observation. Clin Orthop Relat Res. 1990;254:92–6.

    Article  Google Scholar 

  7. Zingg PO, Jost B, Sukthankar A, Buhler M, Pfirrmann CW, Gerber C. Clinical and structural outcomes of nonoperative management of massive rotator cuff tears. J Bone Joint Surg Am. 2007;89(9):1928–34. https://doi.org/10.2106/JBJS.F.01073.

    Article  CAS  PubMed  Google Scholar 

  8. Collin PG, Gain S, Nguyen Huu F, Ladermann A. Is rehabilitation effective in massive rotator cuff tears? Orthop Traumatol Surg Res. 2015;101(4 Suppl):S203–5. https://doi.org/10.1016/j.otsr.2015.03.001.

    Article  CAS  PubMed  Google Scholar 

  9. Levy O, Mullett H, Roberts S, Copeland S. The role of anterior deltoid reeducation in patients with massive irreparable degenerative rotator cuff tears. J Shoulder Elbow Surg. 2008;17(6):863–70. https://doi.org/10.1016/j.jse.2008.04.005.

    Article  PubMed  Google Scholar 

  10. Savarese E, Romeo R. New solution for massive, irreparable rotator cuff tears: the subacromial “biodegradable spacer.” Arthrosc Tech. 2012;1(1):e69-74. https://doi.org/10.1016/j.eats.2012.02.002.

    Article  PubMed  PubMed Central  Google Scholar 

  11. • Singh S, Reeves J, Langohr GDG, Johnson JA, Athwal GS. The subacromial balloon spacer versus superior capsular reconstruction in the treatment of irreparable rotator cuff tears: a biomechanical assessment. Arthroscopy. 2019;35(2):382–9. https://doi.org/10.1016/j.arthro.2018.09.016. Biomechanical study comparing superior capsular reconstruction with subacromial balloon implantation. Both techniques restored humeral head migration and restored abduction forces after tear creation. No significant differences were seen between either technique in biomechanical outcome.

    Article  PubMed  Google Scholar 

  12. Kunze KN, Moran J, Taylor SA, et al. Subacromial balloon spacer implantation for massive irreparable rotator cuff tears is associated with restoration of the acromiohumeral interval and glenohumeral center of pressure: a systematic review and meta-analysis of controlled laboratory studies. Am J Sports Med. 2023:3635465221150652. https://doi.org/10.1177/03635465221150652.

  13. Kunze KN, Moran J, Cecere R, et al. High rate of clinically meaningful achievement in outcomes after subacromial balloon spacer implantation for massive irreparable rotator cuff tears: a systematic review and meta-analysis. Am J Sports Med. 2023:3635465231155916. https://doi.org/10.1177/03635465231155916.

  14. Senekovic V, Poberaj B, Kovacic L, et al. The biodegradable spacer as a novel treatment modality for massive rotator cuff tears: a prospective study with 5-year follow-up. Arch Orthop Trauma Surg. 2017;137(1):95–103. https://doi.org/10.1007/s00402-016-2603-9.

    Article  PubMed  Google Scholar 

  15. Senekovic V, Poberaj B, Kovacic L, Mikek M, Adar E, Dekel A. Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. Eur J Orthop Surg Traumatol. 2013;23(3):311–6. https://doi.org/10.1007/s00590-012-0981-4.

    Article  PubMed  Google Scholar 

  16. •• Sandler AB, Gil LG, Scanaliato JP, Green CK, Dunn JC, Parnes N. Subacromial balloon placement demonstrates no advantage over debridement in the treatment of massive irreparable rotator cuff tears: a dual-armed systematic review and meta-analysis of over 1000 patients. Am J Sports Med. 2023:3635465231168127. https://doi.org/10.1177/03635465231168127Latest systematic review comparing the use of a subacromial balloon compared with debridement. Authors found no clear clinical benefit, however noted shorter operative time and longer conversion time to reverse total shoulder arthroplasty with debridement. However, only two of the included studies are of Level 1 evidence.

  17. Gervasi E, Maman E, Dekel A, Cautero E. Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears. Musculoskelet Surg. 2016;100(Suppl 1):19–24. https://doi.org/10.1007/s12306-016-0433-0.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. Rockwood CA, Williams GR, Burkhead WZ. Débridement of degenerative, irreparable lesions of the rotator cuff. J Bone Joint Surg Am. 1995;77(6):857–66. https://doi.org/10.2106/00004623-199506000-00006.

    Article  PubMed  Google Scholar 

  19. Burkhart SS. Arthroscopic treatment of massive rotator cuff tears. Clinical results and biomechanical rationale. Clin Orthop Relat Res. 1991;267:45–56.

    Article  Google Scholar 

  20. Matsen FA, Whitson A, Jackins SE, Hsu JE. Significant improvement in patient self-assessed comfort and function at six weeks after the smooth and move procedure for shoulders with irreparable rotator cuff tears and retained active elevation. Int Orthop. 2019;43(7):1659–67. https://doi.org/10.1007/s00264-019-04310-4.

    Article  PubMed  Google Scholar 

  21. Scheibel M, Lichtenberg S, Habermeyer P. Reversed arthroscopic subacromial decompression for massive rotator cuff tears. J Shoulder Elbow Surg. 2004;13(3):272–8. https://doi.org/10.1016/j.jse.2004.01.007.

    Article  PubMed  Google Scholar 

  22. Mirzayan R, Bouz G. Biologic tuberoplasty with an acellular dermal allograft for massive rotator cuff tears. Arthrosc Tech. 2021;10(7):e1743–9. https://doi.org/10.1016/j.eats.2021.03.016.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Ravenscroft M, Barnes MW, Muench LN, Mazzocca AD, Berthold DP. Bursal acromial reconstruction (BAR) using an acellular dermal allograft as a surgical solution for the treatment of massive irreparable rotator cuff tears. Arthrosc Tech. 2021;10(3):e877–85. https://doi.org/10.1016/j.eats.2020.11.002.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Johns WL, Ailaney N, Lacy K, Golladay GJ, Vanderbeck J, Kalore NV. Implantable subacromial balloon spacers in patients with massive irreparable rotator cuff tears: a systematic review of clinical, biomechanical, and financial implications. Arthrosc Sports Med Rehabil. 2020;2(6):e855–72. https://doi.org/10.1016/j.asmr.2020.06.011.

    Article  PubMed  PubMed Central  Google Scholar 

  25. •• Verma N, Srikumaran U, Roden CM, et al. InSpace implant compared with partial repair for the treatment of full-thickness massive rotator cuff tears: a multicenter, single-blinded, randomized controlled trial. J Bone Joint Surg Am. 2022;104(14):1250–62. https://doi.org/10.2106/JBJS.21.00667. North American Level 1 study comparing the use of InSpace device with partial rotator cuff repair. Authors found significant clinical improvements at 12 months from baseline, and these were maintained at 24 months.

    Article  PubMed  Google Scholar 

  26. •• Metcalfe A, Parsons H, Parsons N, et al. Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial. Lancet. 2022;399(10339):1954–63. https://doi.org/10.1016/S0140-6736(22)00652-3. First Level 1 study investigating the use of the subacromial balloon compared with subacromial debridement and biceps tenotomy. Authors found a clinical improvement in both groups, yet arthroscopic debridement without balloon implantation was significantly superior compared with balloon implantation.

    Article  CAS  PubMed  Google Scholar 

  27. Boileau P, Rumian AP, Zumstein MA. Reversed shoulder arthroplasty with modified L'Episcopo for combined loss of active elevation and external rotation. J Shoulder Elbow Surg. 2010;19(2 Suppl):20–30. https://doi.org/10.1016/j.jse.2009.12.011.

    Article  PubMed  Google Scholar 

  28. Hartzler RU, Steen BM, Hussey MM, et al. Reverse shoulder arthroplasty for massive rotator cuff tear: risk factors for poor functional improvement. J Shoulder Elbow Surg. 2015;24(11):1698–706. https://doi.org/10.1016/j.jse.2015.04.015.

    Article  PubMed  Google Scholar 

  29. Zumstein MA, Pinedo M, Old J, Boileau P. Problems, complications, reoperations, and revisions in reverse total shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2011;20(1):146–57. https://doi.org/10.1016/j.jse.2010.08.001.

    Article  PubMed  Google Scholar 

  30. Marigi EM, Johnson QJ, Dholakia R, Borah BJ, Sanchez-Sotelo J, Sperling JW. Cost comparison and complication profiles of superior capsular reconstruction, lower trapezius transfer, and reverse shoulder arthroplasty for irreparable rotator cuff tears. J Shoulder Elbow Surg. 2022;31(4):847–54. https://doi.org/10.1016/j.jse.2021.08.027.

    Article  PubMed  Google Scholar 

  31. Gabig AM, Burkhart SS, Denard PJ, Proffitt JM, Hartzler RU. Similar value demonstrated in the short-term outcomes of superior capsular reconstruction and reverse shoulder arthroplasty for massive rotator cuff tears. Arthrosc Sports Med Rehabil. 2023;5(1):e249–55. https://doi.org/10.1016/j.asmr.2022.11.022.

    Article  PubMed  PubMed Central  Google Scholar 

  32. • Castagna A, Garofalo R, Maman E, Gray AC, Brooks EA. Comparative cost-effectiveness analysis of the subacromial spacer for irreparable and massive rotator cuff tears. Int Orthop. 2019;43(2):395–403. https://doi.org/10.1007/s00264-018-4065-x. Economic analysis comparing the use of subacromial balloons with arthroscopic rotator cuff repair, shoulder arthroplasty and non-surgical management. Authors found the subacromial balloon to be the most effective option, both clinically and economically.

    Article  PubMed  Google Scholar 

  33. Luthringer TA, Fares MY, Rondon AJ, Vaughan AK, Khan AZ, Abboud JA. Subacromial balloon spacer versus partial rotator cuff repair in the treatment of massive irreparable rotator cuff tears: facility personnel allocation and procedural cost analysis. Cureus. 2023;15(7):e41538. https://doi.org/10.7759/cureus.41538.

    Article  PubMed  PubMed Central  Google Scholar 

  34. • Maman E, Safran O, Beyth S, et al. Biceps tenotomy does not affect the functional outcomes of patients treated with spacer implantation due to massive irreparable rotator cuff tears. Open Orthop J. 2017;11:1577–84. https://doi.org/10.2174/1874325001711011577. Cohort analysis of 48 patients who underwent subacromial balloon spacer implantation with or without biceps tenotomy. At 12 months, the Constant Score in the tenotomy group increased from 38 to 72, whereas the non-tenotomy group increased from 35 to 69, showing no significant difference between groups.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Grubhofer F, Ernstbrunner L, Gerber C, et al. Effect of abduction brace wearing compliance on the results of arthroscopic rotator cuff repair. JB JS Open Access. 2022;7(2). https://doi.org/10.2106/JBJS.OA.21.00148

Download references

Funding

No funding was received.

Author information

Authors and Affiliations

  1. Lancaster University Medical School, Lancaster, UK

    Yash Sewpaul

  2. San Antonio Military Medical Center, San Antonio, TX, USA

    Andrew J. Sheean

  3. Manchester University NHS Foundation Trust, Manchester, UK

    Mustafa S. Rashid

  4. TSAOG Orthopaedics, 19138 U.S. Hwy 281 N, San Antonio, TX, 78258, USA

    Robert U. Hartzler

Authors
  1. Yash Sewpaul
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Andrew J. Sheean
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Mustafa S. Rashid
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Robert U. Hartzler
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Robert U. Hartzler.

Ethics declarations

Conflict of Interest

Yash Sewpaul and Mustafa Rashid declare they have no conflict of interest. Andrew Sheean declares: American Orthopaedic Society for Sports Medicine: Board or committee member, Arthroscopy: Editorial or governing board, Society of Military Orthopaedic Surgeons: Board or committee member, Springbok Analytics: Stock or stock Options, Stryker: Paid consultant. Robert Hartzler declares: American Shoulder and Elbow Surgeons: Board or committee member, Arthroscopy: Editorial or governing board, Arthroscopy Association of North America: Board or committee member, Stryker: Paid consultant; Research support, Wolters Kluwer Health—Lippincott Williams & Wilkins: Publishing royalties, financial or material support.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Sewpaul, Y., Sheean, A.J., Rashid, M.S. et al. Subacromial Balloon Spacer for the Massive Irreparable Cuff Tear. Curr Rev Musculoskelet Med 17, 47–57 (2024). https://doi.org/10.1007/s12178-023-09879-3

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12178-023-09879-3

Keywords

Search

Navigation