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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

  • Arthroscopy and Sports Medicine
  • Published:
Archives of Orthopaedic and Trauma Surgery Aims and scope Submit manuscript

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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Acknowledgements

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

Author information

Authors and Affiliations

  1. Department of Traumatology, University Medical Centre, Ljubljana, Slovenia

    Vladimir Senekovic & Ladislav Kovacic

  2. Valdoltra Orthopedic Hospital, Ankaran, Slovenia

    Boris Poberaj

  3. Center for Orthopedic Surgery and Sports Medicine, Novo Mesto, Slovenia

    Martin Mikek

  4. Department of Orthopedic Surgery, E. Wolfson Medical Center, Holon, Israel

    Eliyahu Adar

  5. Ortho-Space Ltd, Caesarea, Israel

    Elana Markovitz

  6. Shoulder Unit, Orthopedic Surgery Division, Tel Aviv Medical Center, 6 Weizman Street, 64239, Tel Aviv, Israel

    Eran Maman

  7. Advanced Orthopedic Center, Assuta Medical Center, Tel Aviv, Israel

    Assaf Dekel

Authors
  1. Vladimir Senekovic
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  2. Boris Poberaj
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  3. Ladislav Kovacic
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  4. Martin Mikek
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  5. Eliyahu Adar
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  6. Elana Markovitz
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  7. Eran Maman
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  8. Assaf Dekel
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Corresponding author

Correspondence to Eran Maman.

Additional information

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

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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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  • DOI: https://doi.org/10.1007/s00402-016-2603-9

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