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64th Annual Meeting of the German Society of Neurosurgery (DGNC)

German Society of Neurosurgery (DGNC)

26 - 29 May 2013, Düsseldorf

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Hyalospine® is safe and shows less fibrosis in patients who underwent laminotomy. A multicenter, prospective randomized, double-blind controlled clinical trial

Meeting Abstract

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  • Frank Kandziora - Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt
  • Andreas Pingel - Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt
  • Stavros Stavridis - Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt
  • Paul Pavlov - St. Maartens Kliniek, Nijmegen, Niederlande

Deutsche Gesellschaft für Neurochirurgie. 64. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC). Düsseldorf, 26.-29.05.2013. Düsseldorf: German Medical Science GMS Publishing House; 2013. DocMO.20.02

doi: 10.3205/13dgnc174, urn:nbn:de:0183-13dgnc1742

Published: May 21, 2013

© 2013 Kandziora et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Objective: Hyalospine® is a novel anti-adhesion gel which is a physical combination of sulfated hyaluronate and gellan gum. The aim of this clinical trial was to confirm the safety and efficacy of Hyalospine® for the prevention of adhesions and fibrosis following single- or two-level lumbar laminotomy.

Method: Thirty-eight subjects with degenerative spinal stenosis or disc herniation were randomized to either the Hyalospine® or control groups in a ratio of 1:1. Follow-ups were scheduled at 6 weeks, 6 months, and 1 year. Throughout the 12-month safety analysis period, all adverse events were reported and classified using the MedDRA system, and hematological and immunological response tests were completed. For the assessment of Hyalospine® efficacy, magnetic resonance imaging was used to determine the extent of epidural fibrosis. Further assessments included patient-reported outcome measures (Oswestry Disability Index, Pain Numeric Rating Scale, Short Form-36, EuroQol 5D, and Zurich Claudication questionnaires) were employed to assess physical function, pain, disability, symptoms, and quality of life/health status and examination of neurological status based on clinical evaluations of motor function, reflex and sensory domains.

Results: No SAEs were found in the Hyalospine® subjects. Multiple altered immunological parameters were not considered to be clinically significant. Hyalospine® subjects had less fibrosis compared to the control group at 6 and 12 months, but this outcome was only significantly different at the earlier time point (14% vs. 18%, p = 0.017). All subjects showed clear improvements of symptoms after surgery, but there were no significant differences in all patient reported outcome measures between the Hyalospine® and control groups. In addition, a larger percentage of Hyalospine® subjects improved in all assessed neurological domains compared to the controls, although this was not significantly different (62% vs. 46%, p = 0.433).

Conclusions: Hyalospine® is easy to use and showed a good safety profile in patients with spinal stenosis or disc herniation who underwent laminotomy. No SAEs or device-related safety issues arose during the 12-month trial period for subjects treated with Hyalospine®. There was a tendency for Hyalospine® subjects having less fibrosis throughout the 12-month study period; however, a greater number of subjects would be required to confirm efficacy.