Skip to main content
SpringerLink
Log in

Subacromial balloon spacer implantation for patients with massive irreparable rotator cuff tears achieves satisfactory clinical outcomes in the short and middle of follow-up period: a meta-analysis

  • SHOULDER
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

This meta-analysis was performed systematically to evaluate the efficacy of subacromial balloon spacers for patients with massive, irreparable rotator cuff tears.

Methods

Electronic databases, including Medline/PubMed, Embase and Cochrane Library, were systematically searched to identify studies evaluating the efficacy of subacromial spacers for patients with irreparable or massive rotator cuff tears. Meta-analyses were performed to pool the outcome estimates of interest, such as the total constant score (TCS) and its sub-score (pain, activities of daily living [ADL], range of motion [ROM], and strength), Oxford shoulder score (OSS), American Shoulder and Elbow Society scores (ASES) and numeric rating scale (NRS), as well as different outcomes at different time points in the follow-up period.

Results

Ten studies with a total of 261 patients involving 270 shoulders were deemed viable for inclusion in the meta-analysis. The combined results demonstrated significant improvements in the TCS at the final follow-up (pooled mean difference = 26.4, 95% confidence intervals [CIs] 23.3 to 29.5). A sensitivity analysis and subgroup analysis, which were implemented based on two factors, different follow-up points and sub-scores (pain, ADL, ROM, and strength), revealed a consistent trend. The combined shoulder motion results demonstrated significant improvements in the forward flexion and external rotation (0° abduction) variables rather than in the abduction and external rotation (90° abduction) variables. Additionally, significant improvements in the OSS and ASES and a decrease in the NRS were observed in the middle of the follow-up period.

Conclusion

This meta-analysis indicated that subacromial balloon spacer implantation for patients with massive irreparable rotator cuff tears may achieve satisfactory outcomes between 3 months and 3 years of follow-ups. Although the short- and middle- term effect is significant, the long-term effect needs to be confirmed by large-sample randomized controlled trial.

Level of evidence

IV.

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.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

Abbreviations

ADL:

Activities of daily living

ASES:

American Shoulder and Elbow Society scores

CIs:

Confidence intervals

ISB:

InSpace™ balloon

MD:

Mean difference

MINORS:

Methodological index for non-randomized studies

NRS:

Numeric rating scale

OSS:

Oxford shoulder score

PRISMA:

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

RCTs:

Rotator cuff tears

ROM:

Range of motion

RTSA:

Reverse total shoulder arthroplasty

SCR:

Superior capsular reconstruction

SD:

Standard deviation

TCS:

Total constant score

References

  1. Baig MN, Glynn OA, Kaar K (2018) Technical Report: Biodegradable spacer device for irreparable rotator cuff tears. Cureus 10:e3307

    CAS  PubMed  PubMed Central  Google Scholar 

  2. Bedi A, Dines J, Warren RF, Dines DM (2010) Massive tears of the rotator cuff. J Bone Jt Surg Am 92:1894–1908

    Article  Google Scholar 

  3. Berth A, Neumann W, Awiszus F, Pap G (2010) Massive rotator cuff tears: functional outcome after debridement or arthroscopic partial repair. J Orthop Traumatol 11:13–20

    Article  PubMed  PubMed Central  Google Scholar 

  4. Boileau P, Baque F, Valerio L, Ahrens P, Chuinard C, Trojani C (2007) Isolated arthroscopic biceps tenotomy or tenodesis improves symptoms in patients with massive irreparable rotator cuff tears. J Bone Jt Surg Am 89:747–757

    Article  Google Scholar 

  5. Boileau P, Melis B, Duperron D, Moineau G, Rumian AP, Han Y (2013) Revision surgery of reverse shoulder arthroplasty. J Shoulder Elbow Surg 22:1359–1370

    Article  PubMed  Google Scholar 

  6. Burkhart SS, Nottage WM, Ogilvie-Harris DJ, Kohn HS, Pachelli A (1994) Partial repair of irreparable rotator cuff tears. Arthroscopy 10:363–370

    Article  CAS  PubMed  Google Scholar 

  7. Burks CA, Bundy K, Fotuhi P, Alt E (2006) Characterization of 75:25 poly(l-lactide-co-epsilon-caprolactone) thin films for the endoluminal delivery of adipose-derived stem cells to abdominal aortic aneurysms. Tissue Eng 12:2591–2600

    Article  CAS  PubMed  Google Scholar 

  8. Carver TJ, Kraeutler MJ, Smith JR, Bravman JT, McCarty EC (2018) Nonarthroplasty surgical treatment options for massive, irreparable rotator cuff tears. Orthop J Sports Med 6:2325967118805385

    PubMed  PubMed Central  Google Scholar 

  9. Castagna A, Garofalo R, Maman E, Gray AC, Brooks EA (2019) Comparative cost-effectiveness analysis of the subacromial spacer for irreparable and massive rotator cuff tears. Int Orthop 43:395–403

    Article  PubMed  Google Scholar 

  10. Chen KH, Chiang ER, Wang HY, Ma HL (2017) Arthroscopic partial repair of irreparable rotator cuff tears: factors related to greater degree of clinical improvement at 2 years of follow-up. Arthroscopy 33:1949–1955

    Article  PubMed  Google Scholar 

  11. Chevalier Y, Pietschmann MF, Thorwachter C, Chechik O, Adar E, Dekel A et al (2018) Biodegradable spacer reduces the subacromial pressure: a biomechanical cadaver study. Clin Biomech (Bristol, Avon) 52:41–48

    Article  Google Scholar 

  12. Cofield RH, Parvizi J, Hoffmeyer PJ, Lanzer WL, Ilstrup DM, Rowland CM (2001) Surgical repair of chronic rotator cuff tears. A prospective long-term study. J Bone Jt Surg Am 83-A:71–77

    Article  Google Scholar 

  13. Cohen J (1968) Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull 70:213–220

    Article  CAS  PubMed  Google Scholar 

  14. Deranlot J, Herisson O, Nourissat G, Zbili D, Werthel JD, Vigan M et al (2017) Arthroscopic subacromial spacer implantation in patients with massive irreparable rotator cuff tears: clinical and radiographic results of 39 retrospectives cases. Arthroscopy 33:1639–1644

    Article  PubMed  Google Scholar 

  15. Fu KM, Smith JS, Polly DW Jr, Ames CP, Berven SH, Perra JH et al (2011) Correlation of higher preoperative American Society of Anesthesiology grade and increased morbidity and mortality rates in patients undergoing spine surgery. J Neurosurg Spine 14:470–474

    Article  PubMed  Google Scholar 

  16. Gerber C, Canonica S, Catanzaro S, Ernstbrunner L (2018) Longitudinal observational study of reverse total shoulder arthroplasty for irreparable rotator cuff dysfunction: results after 15 years. J Shoulder Elbow Surg 27:831–838

    Article  PubMed  Google Scholar 

  17. Gerber C, Wirth SH, Farshad M (2011) Treatment options for massive rotator cuff tears. J Shoulder Elbow Surg 20:S20–S29

    Article  PubMed  Google Scholar 

  18. Gervasi E, Cautero E, Dekel A (2014) Fluoroscopy-guided implantation of subacromial “biodegradable spacer” using local anesthesia in patients with irreparable rotator cuff tear. Arthrosc Tech 3:e455–e458

    Article  PubMed  PubMed Central  Google Scholar 

  19. Gervasi E, Maman E, Dekel A, Cautero E (2016) Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears. Musculoskelet Surg 100:19–24

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. Green A (2003) Chronic massive rotator cuff tears: evaluation and management. J Am Acad Orthop Surg 11:321–331

    Article  PubMed  Google Scholar 

  21. Habermeyer P, Magosch P, Rudolph T, Lichtenberg S, Liem D (2006) Transfer of the tendon of latissimus dorsi for the treatment of massive tears of the rotator cuff: a new single-incision technique. J Bone Jt Surg Br 88:208–212

    Article  CAS  Google Scholar 

  22. Heuberer PR, Kolblinger R, Buchleitner S, Pauzenberger L, Laky B, Auffarth A et al (2016) Arthroscopic management of massive rotator cuff tears: an evaluation of debridement, complete, and partial repair with and without force couple restoration. Knee Surg Sports Traumatol Arthrosc 24:3828–3837

    Article  PubMed  Google Scholar 

  23. Higgins JP, Green S (2011) Cochrane handbook for systematic reviews of interventions. Wiley-Blackwell, Chichester Hoboken

    Google Scholar 

  24. Holschen M, Brand F, Agneskirchner JD (2017) Subacromial spacer implantation for massive rotator cuff tears: clinical outcome of arthroscopically treated patients. Obere Extrem 12:38–45

    Article  PubMed  Google Scholar 

  25. Hunt LP, Ben-Shlomo Y, Clark EM, Dieppe P, Judge A, MacGregor AJ et al (2013) 90-day mortality after 409,096 total hip replacements for osteoarthritis, from the National Joint Registry for England and Wales: a retrospective analysis. Lancet 382:1097–1104

    Article  PubMed  Google Scholar 

  26. Kane TP, Rogers P, Hazelgrove J, Wimsey S, Harper GD (2008) Pulsed radiofrequency applied to the suprascapular nerve in painful cuff tear arthropathy. J Shoulder Elbow Surg 17:436–440

    Article  PubMed  Google Scholar 

  27. Kang JR, Sin AT, Cheung EV (2017) Treatment of massive irreparable rotator cuff tears: a cost-effectiveness analysis. Orthopedics 40:e65–e76

    Article  PubMed  Google Scholar 

  28. Lee BG, Cho NS, Rhee YG (2011) Results of arthroscopic decompression and tuberoplasty for irreparable massive rotator cuff tears. Arthroscopy 27:1341–1350

    Article  PubMed  Google Scholar 

  29. Liem D, Lengers N, Dedy N, Poetzl W, Steinbeck J, Marquardt B (2008) Arthroscopic debridement of massive irreparable rotator cuff tears. Arthroscopy 24:743–748

    Article  PubMed  Google Scholar 

  30. Malahias MA, Brilakis E, Avramidis G, Antonogiannakis E (2019) Satisfactory mid-term outcome of subacromial balloon spacer for the treatment of irreparable rotator cuff tears. Knee Surg Sports Traumatol Arthrosc. https://doi.org/10.1007/s00167-019-05485-4

    Article  PubMed  Google Scholar 

  31. Maman E, Safran O, Beyth S, Mozes G, Dekel A, Michael B et al (2017) Biceps tenotomy does not affect the functional outcomes of patients treated with spacer implantation due to massive irreparable rotator cuff tears. Open Orthop J 11:1577–1584

    Article  PubMed  PubMed Central  Google Scholar 

  32. Mazzocca AD, Bollier M, Fehsenfeld D, Romeo A, Stephens K, Solovyoya O et al (2011) Biomechanical evaluation of margin convergence. Arthroscopy 27:330–338

    Article  PubMed  Google Scholar 

  33. Mihata T, Lee TQ, Watanabe C, Fukunishi K, Ohue M, Tsujimura T et al (2013) Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. Arthroscopy 29:459–470

    Article  PubMed  Google Scholar 

  34. Mihata T, McGarry MH, Pirolo JM, Kinoshita M, Lee TQ (2012) Superior capsule reconstruction to restore superior stability in irreparable rotator cuff tears: a biomechanical cadaveric study. Am J Sports Med 40:2248–2255

    Article  PubMed  Google Scholar 

  35. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 6:e1000097

    Article  PubMed  PubMed Central  Google Scholar 

  36. Moon AS, Patel HA, Ithurburn MP, Brabston EW, Ponce BA, Momaya AM (2019) Subacromial spacer implantation for the treatment of massive irreparable rotator cuff tears: a systematic review. Arthroscopy 35:607–614

    Article  PubMed  Google Scholar 

  37. Moore DR, Cain EL, Schwartz ML, Clancy WG Jr (2006) Allograft reconstruction for massive, irreparable rotator cuff tears. Am J Sports Med 34:392–396

    Article  PubMed  Google Scholar 

  38. Moser M, Jablonski MV, Horodyski M, Wright TW (2007) Functional outcome of surgically treated massive rotator cuff tears: a comparison of complete repair, partial repair, and debridement. Orthopedics 30:479–482

    Article  PubMed  Google Scholar 

  39. Mulieri P, Dunning P, Klein S, Pupello D, Frankle M (2010) Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Jt Surg Am 92:2544–2556

    Article  Google Scholar 

  40. Neri BR, Chan KW, Kwon YW (2009) Management of massive and irreparable rotator cuff tears. J Shoulder Elbow Surg 18:808–818

    Article  PubMed  Google Scholar 

  41. Nizlan NM, Skirving AP, Campbell PT (2009) Arthroscopic suprascapular neurectomy for the management of severe shoulder pain. J Shoulder Elbow Surg 18:245–250

    Article  PubMed  Google Scholar 

  42. Ozaki J, Fujimoto S, Masuhara K, Tamai S, Yoshimoto S (1986) Reconstruction of chronic massive rotator cuff tears with synthetic materials. Clin Orthop Relat Res 202:173–183

    Google Scholar 

  43. Parvizi J, Johnson BG, Rowland C, Ereth MH, Lewallen DG (2001) Thirty-day mortality after elective total hip arthroplasty. J Bone Jt Surg Am 83-A:1524–1528

    Article  Google Scholar 

  44. Piekaar RSM, Bouman ICE, van Kampen PM, van Eijk F, Huijsmans PE (2018) Early promising outcome following arthroscopic implantation of the subacromial balloon spacer for treating massive rotator cuff tear. Musculoskelet Surg 102:247–255

    Article  CAS  PubMed  Google Scholar 

  45. Prat D, Tenenbaum S, Pritsch M, Oran A, Vogel G (2018) Sub-acromial balloon spacer for irreparable rotator cuff tears: is it an appropriate salvage procedure? J Orthop Surg (Hong Kong) 26(2):2309499018770887

    Article  Google Scholar 

  46. Ramot Y, Nyska A, Markovitz E, Dekel A, Klaiman G, Zada MH et al (2015) Long-term local and systemic safety of poly(l-lactide-co-epsilon-caprolactone) after subcutaneous and intra-articular implantation in rats. Toxicol Pathol 43:1127–1140

    Article  CAS  PubMed  Google Scholar 

  47. Ricci M, Vecchini E, Bonfante E, Micheloni GM, Berti M, Schenal G et al (2017) A clinical and radiological study of biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tears. Acta Biomed 88:75–80

    PubMed  PubMed Central  Google Scholar 

  48. Ruiz Iban MA, Lorente Moreno R, Ruiz Diaz R, Alvarez Sciamanna R, Paniagua Gonzalez A, Lorente Gomez A et al (2018) The absorbable subacromial spacer for irreparable posterosuperior cuff tears has inconsistent results. Knee Surg Sports Traumatol Arthrosc 26:3848–3854

    Article  PubMed  Google Scholar 

  49. Sartoretti C, Sartoretti-Schefer S, Duff C, Buchmann P (1996) Angioplasty balloon catheters used for distraction of the ankle joint. Arthroscopy 12:82–86

    Article  CAS  PubMed  Google Scholar 

  50. Savarese E, Romeo R (2012) New solution for massive, irreparable rotator cuff tears: the subacromial “biodegradable spacer”. Arthrosc Tech 1:e69–e74

    Article  PubMed  PubMed Central  Google Scholar 

  51. Scheibel M, Lichtenberg S, Habermeyer P (2004) Reversed arthroscopic subacromial decompression for massive rotator cuff tears. J Shoulder Elbow Surg 13:272–278

    Article  PubMed  Google Scholar 

  52. Senekovic V, Poberaj B, Kovacic L, Mikek M, Adar E, Dekel A (2013) Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. Eur J Orthop Surg Traumatol 23:311–316

    Article  PubMed  Google Scholar 

  53. Senekovic V, Poberaj B, Kovacic L, Mikek M, Adar E, Markovitz E et al (2017) 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 137:95–103

    Article  PubMed  Google Scholar 

  54. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J (2003) Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg 73:712–716

    Article  PubMed  Google Scholar 

  55. Walch G, Edwards TB, Boulahia A, Nove-Josserand L, Neyton L, Szabo I (2005) Arthroscopic tenotomy of the long head of the biceps in the treatment of rotator cuff tears: clinical and radiographic results of 307 cases. J Shoulder Elbow Surg 14:238–246

    Article  PubMed  Google Scholar 

  56. Wall B, Nove-Josserand L, O’Connor DP, Edwards TB, Walch G (2007) Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Jt Surg Am 89:1476–1485

    Google Scholar 

  57. Warner JJ (2001) Management of massive irreparable rotator cuff tears: the role of tendon transfer. Instr Course Lect 50:63–71

    CAS  PubMed  Google Scholar 

  58. Werner CM, Steinmann PA, Gilbart M, Gerber C (2005) Treatment of painful pseudoparesis due to irreparable rotator cuff dysfunction with the Delta III reverse-ball-and-socket total shoulder prosthesis. J Bone Jt Surg Am 87:1476–1486

    CAS  Google Scholar 

  59. Yallapragada RK, Apostolopoulos A, Katsougrakis I, Selvan TP (2018) The use of a subacromial spacer-inspace balloon in managing patients with irreparable rotator cuff tears. J Orthop 15:862–868

    Article  PubMed  PubMed Central  Google Scholar 

  60. Yamamoto A, Takagishi K, Osawa T, Yanagawa T, Nakajima D, Shitara H et al (2010) Prevalence and risk factors of a rotator cuff tear in the general population. J Shoulder Elbow Surg 19:116–120

    Article  PubMed  Google Scholar 

  61. Zumstein MA, Jost B, Hempel J, Hodler J, Gerber C (2008) The clinical and structural long-term results of open repair of massive tears of the rotator cuff. J Bone Jt Surg Am 90:2423–2431

    Article  Google Scholar 

  62. Zumstein MA, Pinedo M, Old J, Boileau P (2011) Problems, complications, reoperations, and revisions in reverse total shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg 20:146–157

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

This study was supported by China Scholarship Council (CSC) which funded two of the authors (Fanxiao Liu, CSC, NO.: 201808080126; Fei Xiong, CSC, NO.: 201706920036) and the Key R & D program in Shandong Province (Jinlei Dong, NO.: 2016GSF201214).

Funding

There is no funding source.

Author information

Authors and Affiliations

  1. Department of Orthopaedics, Shandong Provincial Hospital Affiliated to Shandong University, No. 324, Road Jing Wu Wei Qi, Jinan, 250021, Shandong, China

    Fanxiao Liu, Jinlei Dong & Dongsheng Zhou

  2. Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Yishan Road 600, Xuhui District, Shanghai, 200233, China

    Qinglin Kang & Fei Xiong

Authors
  1. Fanxiao Liu
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jinlei Dong
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Qinglin Kang
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Dongsheng Zhou
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Fei Xiong
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

All authors contributed substantially to conception and design, or acquisition of data, or analysis and interpretation of data, drafted the article or revised it critically for important intellectual content, provided final approval of the version to be published, and agreed to act as guarantor of the work (ensuring that questions related to any part of the work are appropriately investigated and resolved).

Corresponding author

Correspondence to Fei Xiong.

Ethics declarations

Conflict of interest

The authors declared that they have no potential conflicts of interests to declare.

Ethical approval

This review did not involve primary data collection from patients and as such research approval was not obtained.

Additional information

Publisher's Note

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

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 14 kb)

Supplementary material 2 (DOCX 1811 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Liu, F., Dong, J., Kang, Q. et al. Subacromial balloon spacer implantation for patients with massive irreparable rotator cuff tears achieves satisfactory clinical outcomes in the short and middle of follow-up period: a meta-analysis. Knee Surg Sports Traumatol Arthrosc 29, 143–153 (2021). https://doi.org/10.1007/s00167-019-05834-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00167-019-05834-3

Keywords

Search

Navigation