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.
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
Baig MN, Glynn OA, Kaar K (2018) Technical Report: Biodegradable spacer device for irreparable rotator cuff tears. Cureus 10:e3307
Bedi A, Dines J, Warren RF, Dines DM (2010) Massive tears of the rotator cuff. J Bone Jt Surg Am 92:1894–1908
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
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
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
Burkhart SS, Nottage WM, Ogilvie-Harris DJ, Kohn HS, Pachelli A (1994) Partial repair of irreparable rotator cuff tears. Arthroscopy 10:363–370
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
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
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
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
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
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
Cohen J (1968) Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull 70:213–220
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
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
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
Gerber C, Wirth SH, Farshad M (2011) Treatment options for massive rotator cuff tears. J Shoulder Elbow Surg 20:S20–S29
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
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
Green A (2003) Chronic massive rotator cuff tears: evaluation and management. J Am Acad Orthop Surg 11:321–331
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
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
Higgins JP, Green S (2011) Cochrane handbook for systematic reviews of interventions. Wiley-Blackwell, Chichester Hoboken
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
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
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
Kang JR, Sin AT, Cheung EV (2017) Treatment of massive irreparable rotator cuff tears: a cost-effectiveness analysis. Orthopedics 40:e65–e76
Lee BG, Cho NS, Rhee YG (2011) Results of arthroscopic decompression and tuberoplasty for irreparable massive rotator cuff tears. Arthroscopy 27:1341–1350
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
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
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
Mazzocca AD, Bollier M, Fehsenfeld D, Romeo A, Stephens K, Solovyoya O et al (2011) Biomechanical evaluation of margin convergence. Arthroscopy 27:330–338
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
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
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
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
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
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
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
Neri BR, Chan KW, Kwon YW (2009) Management of massive and irreparable rotator cuff tears. J Shoulder Elbow Surg 18:808–818
Nizlan NM, Skirving AP, Campbell PT (2009) Arthroscopic suprascapular neurectomy for the management of severe shoulder pain. J Shoulder Elbow Surg 18:245–250
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
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
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
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
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
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
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
Sartoretti C, Sartoretti-Schefer S, Duff C, Buchmann P (1996) Angioplasty balloon catheters used for distraction of the ankle joint. Arthroscopy 12:82–86
Savarese E, Romeo R (2012) New solution for massive, irreparable rotator cuff tears: the subacromial “biodegradable spacer”. Arthrosc Tech 1:e69–e74
Scheibel M, Lichtenberg S, Habermeyer P (2004) Reversed arthroscopic subacromial decompression for massive rotator cuff tears. J Shoulder Elbow Surg 13:272–278
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
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
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
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
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
Warner JJ (2001) Management of massive irreparable rotator cuff tears: the role of tendon transfer. Instr Course Lect 50:63–71
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
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
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
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
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
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
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
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.
Rights and permissions
About this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00167-019-05834-3