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Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears

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European Journal of Orthopaedic Surgery & Traumatology Aims and scope Submit manuscript

Abstract

Purpose

The purposes of this prospective non-randomized study were to confirm the feasibility of the biodegradable sub-acromial spacer (InSpace™) implantation in patients with massive irreparable rotator cuff tear and to determine the safety profile and functional results 3 years post-implantation.

Methods

Twenty patients were implanted with the InSpace™ device and assessed up to 3 years of post-implantation. Improvement in shoulder function was assessed using Constant score, while ease of use of the system was recorded by surgeons as were device-related adverse events.

Results

Twenty patients were available for assessment. Implantation was performed arthroscopically in all patients, and a range of deployment time was 2–20 min. The mean total Constant score increased from 33.4 to 65.4 points at 3 years. There was an improvement of 6.4 points in subjective pain score which commenced at 1 week post-operatively and was sustained until 3 years of follow-up. Also activities of daily living and motions commenced improvement by 9.4 and 7.7 points, respectively. Improvement in power was only evident at 18 months of follow-up but was sustained at 3 years.

Conclusions

Arthroscopic deployment of a co-polymer biodegradable spacer (balloon) into the sub-acromial space for an irreparable rotator cuff tear was found to be low-risk and simple procedure associated with improvement in shoulder function and low rate of complications.

Level of evidence

IV; therapeutic case series

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Conflict of interest

In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from OrthoSpace Ltd. Also, a commercial entity (OrthoSpace Ltd.) paid or directed, or agreed to pay or direct, benefits to a research fund, foundation, educational institution or other charitable or non-profit organization with which the authors are affiliated or associated. Dr. Dekel and Dr. Adar have financial interest in the funding company, while other authors have no such interest.

Author information

Authors and Affiliations

  1. Department of Traumatology, University Medical Centre Ljubljana, Zaloska 2, 1000, Ljubljana, Slovenia

    Vladimir Senekovic & Ladislav Kovacic

  2. Valdoltra Orthopedic Hospital, Jadranska Cesta 31, 6280, Ankaran, Slovenia

    Boris Poberaj

  3. Center for Orthopedic Surgery and Sports Medicine, Novo Mesto General Hospital, ARTROS, Tehnološki Park 21, 1000, Ljubljana, Slovenia

    Martin Mikek

  4. Department of Orthopedic Surgery, E. Wolfson Medical Center, 62 HaLohamim Street, P.O. Box 5, 58100, Holon, Israel

    Eliyahu Adar

  5. Advanced Orthopedic Center, Assuta Medical Center, 20 Habarzel St, Ramat Hachayil, 69710, 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. Assaf Dekel
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Corresponding author

Correspondence to Assaf Dekel.

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Senekovic, V., Poberaj, B., Kovacic, L. et al. 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 (2013). https://doi.org/10.1007/s00590-012-0981-4

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  • DOI: https://doi.org/10.1007/s00590-012-0981-4

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