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European Journal of Orthopaedic Surgery & Traumatology

Published in:

01-04-2013 | Original Article

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

Authors: Vladimir Senekovic, Boris Poberaj, Ladislav Kovacic, Martin Mikek, Eliyahu Adar, Assaf Dekel

Published in: European Journal of Orthopaedic Surgery & Traumatology | Issue 3/2013

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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Title: Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears
Authors: Vladimir Senekovic
Boris Poberaj
Ladislav Kovacic
Martin Mikek
Eliyahu Adar
Assaf Dekel
Publication date: 01-04-2013
Publisher: Springer-Verlag
Published in: European Journal of Orthopaedic Surgery & Traumatology / Issue 3/2013
Print ISSN: 1633-8065
Electronic ISSN: 1432-1068
DOI: https://doi.org/10.1007/s00590-012-0981-4

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Purpose

Methods

Results

Conclusions

Level of evidence

At a glance: The ONWARDS insulin icodec trials

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Abstract

Purpose

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Conclusions

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