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The biodegradable spacer as a novel treatment modality for massive rotator cuff tears: a prospective study with 5-year follow-up

Abstract

Background

The management of massive, irreparable rotator cuff tears (RCT) is challenging and associated with high failure rates. There are no current consensus or definitive guidelines concerning the optimal surgical treatment for this devastating condition. This study was designed to confirm the long-term safety and efficacy of the biodegradable inflatable InSpace™ system in patients with massive reparable or irreparable RCTs.

Methods

In this open-label, single arm, prospective study, subjects with massive RCT underwent subacromial implantation with the biodegradable spacer. Follow-up visits were scheduled according to routine clinical practice. Shoulder function was evaluated using Total Constant Score (TCS).

Results

Twenty-four patients were treated and assessed. Four patients had partial tears, and in three of them RC repair was performed. These patients were not included in the efficacy analyses. Of the participating subjects who reached the 5-year follow-up, 84.6% of the patients showed a clinically significant improvement of at least 15 points in their score, while 61.54% showed at least 25 points of improvement. Only 10% of the treated patients showed no improvement or worsening in the shoulder score comparing to their baseline. An overall improvement in the total CS commencing at 3 months and sustained by 6 months through to 5 years of follow-up (P < 0.0001) was demonstrated.

Conclusions

We conclude that in this initial cohort, arthroscopic implantation of InSpace™ system represented an effective alternative to the existing arthroscopic procedures in patients with painful massive RCT refractory to conservative management. Further randomized controlled trials comparing the clinical and functional outcomes after implantation of the InSpace™ device are warranted.

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References

  1. 1.

    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(1):13–20. doi:10.1007/s10195-010-0084-0

  2. 2.

    Green A (2003) Chronic massive rotator cuff tears: evaluation and management. J Am Acad Orthop Surg 11(5):321–331

  3. 3.

    Gerber C, Wirth SH, Farshad M (2011) Treatment options for massive rotator cuff tears. J Shoulder Elbow Surg 20(2 Suppl):S20–S29. doi:10.1016/j.jse.2010.11.028

  4. 4.

    Omid R, Lee B (2013) Tendon transfers for irreparable rotator cuff tears. J Am Acad Orthop Surg 21(8):492–501. doi:10.5435/JAAOS-21-08-492

  5. 5.

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

  6. 6.

    Hirooka A, Yoneda M, Wakaitani S, Isaka Y, Hayashida K, Fukushima S, Okamura K (2002) Augmentation with a Gore-Tex patch for repair of large rotator cuff tears that cannot be sutured. J Orthop Sci 7(4):451–456. doi:10.1007/s007760200078

  7. 7.

    Moore DR, Cain EL, Schwartz ML, Clancy WG Jr (2006) Allograft reconstruction for massive, irreparable rotator cuff tears. Am J Sports Med 34(3):392–396. doi:10.1177/0363546505281237

  8. 8.

    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

  9. 9.

    Gartsman GM (1990) Arthroscopic acromioplasty for lesions of the rotator cuff. J Bone Joint Surg Am 72(2):169–180

  10. 10.

    Hawkins RJ, Misamore GW, Hobeika PE (1985) Surgery for full-thickness rotator-cuff tears. J Bone Joint Surg Am 67(9):1349–1355

  11. 11.

    Rockwood CA Jr, Williams GR Jr, Burkhead WZ Jr (1995) Debridement of degenerative, irreparable lesions of the rotator cuff. J Bone Joint Surg Am 77(6):857–866

  12. 12.

    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(3):238–246. doi:10.1016/j.jse.2004.07.008

  13. 13.

    Chaudhury S, Holland C, Thompson MS, Vollrath F, Carr AJ (2012) Tensile and shear mechanical properties of rotator cuff repair patches. J Shoulder Elbow Surg 21(9):1168–1176. doi:10.1016/j.jse.2011.08.045

  14. 14.

    Wong I, Burns J, Snyder S (2010) Arthroscopic GraftJacket repair of rotator cuff tears. J Shoulder Elbow Surg 19(2 Suppl):104–109. doi:10.1016/j.jse.2009.12.017

  15. 15.

    Gerber C (1992) Latissimus dorsi transfer for the treatment of irreparable tears of the rotator cuff. Clin Orthop Relat Res 275:152–160

  16. 16.

    Scheibel M, Lichtenberg S, Habermeyer P (2004) Reversed arthroscopic subacromial decompression for massive rotator cuff tears. J Shoulder Elbow Surg 13(3):272–278. doi:10.1016/S1058274604000242

  17. 17.

    Anley CM, Chan SK, Snow M (2014) Arthroscopic treatment options for irreparable rotator cuff tears of the shoulder. World J Orthop 5(5):557–565. doi:10.5312/wjo.v5.i5.557

  18. 18.

    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(3):311–316. doi:10.1007/s00590-012-0981-4

  19. 19.

    Constant CR, Murley AH (1987) A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 214:160–164

  20. 20.

    Savarese E, Romeo R (2012) New solution for massive, irreparable rotator cuff tears: the subacromial “biodegradable spacer”. Arthrosc Tech 1(1):e69–e74. doi:10.1016/j.eats.2012.02.002

  21. 21.

    Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC (1994) Fatty muscle degeneration in cuff ruptures. Pre- and post-operative evaluation by CT scan. Clin Orthop Relat Res 304:78–83

  22. 22.

    Kukkonen J, Kauko T, Vahlberg T, Joukainen A, Aarimaa V (2013) Investigating minimal clinically important difference for Constant score in patients undergoing rotator cuff surgery. J Shoulder Elbow Surg 22(12):1650–1655. doi:10.1016/j.jse.2013.05.002

  23. 23.

    Szabo I, Boileau P, Walch G (2008) The proximal biceps as a pain generator and results of tenotomy. Sports Med Arthrosc 16(3):180–186. doi:10.1097/JSA.0b013e3181824f1e

  24. 24.

    Conboy VB, Morris RW, Kiss J, Carr AJ (1996) An evaluation of the Constant–Murley shoulder assessment. The Journal of bone and joint surgery British 78(2):229–232

  25. 25.

    Burkhart SS, Barth JR, Richards DP, Zlatkin MB, Larsen M (2007) Arthroscopic repair of massive rotator cuff tears with stage 3 and 4 fatty degeneration. Arthroscopy 23(4):347–354. doi:10.1016/j.arthro.2006.12.012

  26. 26.

    Nove-Josserand L, Costa P, Liotard JP, Safar JF, Walch G, Zilber S (2009) Results of latissimus dorsi tendon transfer for irreparable cuff tears. Orthop Traumatol Surg Res 95(2):108–113. doi:10.1016/j.otsr.2008.10.002

  27. 27.

    Lee BG, Cho NS, Rhee YG (2011) Results of arthroscopic decompression and tuberoplasty for irreparable massive rotator cuff tears. Arthroscopy 27(10):1341–1350. doi:10.1016/j.arthro.2011.06.016

  28. 28.

    Sartoretti C, Sartoretti-Schefer S, Duff C, Buchmann P (1996) Angioplasty balloon catheters used for distraction of the ankle joint. Arthroscopy 12(1):82–86

  29. 29.

    Kilinc AS, Ebrahimzadeh MH, Lafosse L (2009) Subacromial internal spacer for rotator cuff tendon repair: “the balloon technique”. Arthroscopy 25(8):921–924. doi:10.1016/j.arthro.2009.02.017

  30. 30.

    Katolik LI, Romeo AA, Cole BJ, Verma NN, Hayden JK, Bach BR (2005) Normalization of the Constant score. J Shoulder Elbow Surg 14(3):279–285. doi:10.1016/j.jse.2004.10.009

  31. 31.

    Gustavson K, von Soest T, Karevold E, Roysamb E (2012) Attrition and generalizability in longitudinal studies: findings from a 15-year population-based study and a Monte Carlo simulation study. BMC Public Health 12:918. doi:10.1186/1471-2458-12-918

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Acknowledgements

Funding was provided by Ortho-Space Ltd, Caesarea, Israel.

Author information

Correspondence to Eran Maman.

Additional information

E. Maman and A. Dekel co-directed the project.

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Cite this article

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 137, 95–103 (2017). https://doi.org/10.1007/s00402-016-2603-9

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Keywords

  • Massive rotator cuff tears
  • Inspace
  • Baloon
  • Functional scores