Archives of Orthopaedic and Trauma Surgery

, Volume 137, Issue 1, pp 95–103 | Cite as

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

  • Vladimir Senekovic
  • Boris Poberaj
  • Ladislav Kovacic
  • Martin Mikek
  • Eliyahu Adar
  • Elana Markovitz
  • Eran Maman
  • Assaf Dekel
Arthroscopy and Sports Medicine



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.


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).


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.


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.


Massive rotator cuff tears Inspace Baloon Functional scores 



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


  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 CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Green A (2003) Chronic massive rotator cuff tears: evaluation and management. J Am Acad Orthop Surg 11(5):321–331CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  5. 5.
    Warner JJ (2001) Management of massive irreparable rotator cuff tears: the role of tendon transfer. Instr Course Lect 50:63–71PubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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 202:173–183Google Scholar
  9. 9.
    Gartsman GM (1990) Arthroscopic acromioplasty for lesions of the rotator cuff. J Bone Joint Surg Am 72(2):169–180CrossRefPubMedGoogle Scholar
  10. 10.
    Hawkins RJ, Misamore GW, Hobeika PE (1985) Surgery for full-thickness rotator-cuff tears. J Bone Joint Surg Am 67(9):1349–1355CrossRefPubMedGoogle Scholar
  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):857–866CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  15. 15.
    Gerber C (1992) Latissimus dorsi transfer for the treatment of irreparable tears of the rotator cuff. Clin Orthop Relat Res 275:152–160Google Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedPubMedCentralGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  19. 19.
    Constant CR, Murley AH (1987) A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 214:160–164Google Scholar
  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 CrossRefPubMedPubMedCentralGoogle Scholar
  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 304:78–83Google Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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):229–232Google Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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):82–86CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedGoogle Scholar
  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 CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Vladimir Senekovic
    • 1
  • Boris Poberaj
    • 2
  • Ladislav Kovacic
    • 1
  • Martin Mikek
    • 3
  • Eliyahu Adar
    • 4
  • Elana Markovitz
    • 5
  • Eran Maman
    • 6
  • Assaf Dekel
    • 7
  1. 1.Department of TraumatologyUniversity Medical CentreLjubljanaSlovenia
  2. 2.Valdoltra Orthopedic HospitalAnkaranSlovenia
  3. 3.Center for Orthopedic Surgery and Sports MedicineNovo MestoSlovenia
  4. 4.Department of Orthopedic SurgeryE. Wolfson Medical CenterHolonIsrael
  5. 5.Ortho-Space LtdCaesareaIsrael
  6. 6.Shoulder Unit, Orthopedic Surgery DivisionTel Aviv Medical CenterTel AvivIsrael
  7. 7.Advanced Orthopedic CenterAssuta Medical CenterTel AvivIsrael

Personalised recommendations