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Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS® in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication

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Abstract

Purpose

New interspinous process decompression devices (IPDs) provide an alternative to conservative treatment and decompressive surgery for patients with neurogenic intermittent claudication (NIC) due to degenerative lumbar spinal stenosis (DLSS). APERIUS® is a minimally invasive IPD that can be implanted percutaneously. This multicentre prospective study was designed to make a preliminary evaluation of safety and effectiveness of this IPD up to 12 months post-implantation.

Methods

After percutaneous implantation in 156 patients with NIC due to DLSS, data on symptoms, quality of life, pain, and use of pain medication were obtained for up to 12 months.

Results

Early symptom and physical function improvements were maintained for up to 12 months, when 60 and 58 % of patients maintained an improvement higher than the Minimum Clinically Important Difference for Zurich Claudication Questionnaire (ZCQ) symptom severity and physical function, respectively. Leg, buttock/groin, and back pain were eased throughout, and the use and strength of related pain medication were reduced. Devices were removed from 9 % of patients due to complications or lack of effectiveness.

Conclusions

Overall, in a period of up to 12 months follow-up, the safety and effectiveness of the APERIUS® offered a minimally invasive option for the relief of NIC complaints in a high proportion of patients. Further studies are underway to provide insight on outcomes and effectiveness compared to other decompression methods, and to develop guidance on optimal patient selection.

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Acknowledgments

The INCA study investigators and their staff for data collection: (1) Belgium: Dr Fransen and Dr Collignon, Brussels (35 patients); Dr Jodaitis and Dr Morelli, La Louviere (28 patients); Dr Van Meirhaeghe, Brugge (25 patients); Dr Scordidis, Montignies sur Sambre (10 patients); Dr Lambert, Mons (2 patients); Dr Hes, Antwerpen (1 patient). (2) Germany: Dr Stavros and Dr Richter, Schwandorf (19 patients); Dr Bachus and Dr Godde, Düsseldorf (13 patients); Dr Weisskopf, Polonius, and Dr Wierscher, Schwarzach (4 patients); Dr Kolvenbach, Erlangen (2 patients); Dr Sobottke and Dr Kaulhausen, Köln (1 patient). (3) United Kingdom: Mr Craig, Aberdeen (17 patients).

Prof Albert and Anne-Françoise Donneau (statisticians), Dr Brat (central reader), and Quintiles (writing assistance), all funded by Medtronic.

Conflict of interest

J.V.M. is a consultant with Medtronic, Synthes; P.F. is a consultant with Medtronic, SpineArt, Covidien; D.M. is a consultant with Medtronic, Stryker; N.C. is a consultant with Medtronic; A.M. is a former employee of Medtronic; G.G. is a consultant with Medtronic; and F.C. is a consultant with Medtronic, Alphatec. This study was sponsored by Medtronic Spinal and Biologics Europe BVBA (now Medtronic Bakken Research Center BV, Endepolsdomein 5, 6229 GW Maastricht, The Netherlands).

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Authors and Affiliations

  1. Dienst Orthopedie en Traumatologie, AZ Sint-Jan Brugge-Oostende AV, Ruddershove 10, 8000, Brugge, Belgium

    Jan Van Meirhaeghe

  2. Centre Neurochirurgical de Bruxelles, Clinique du Parc Léopold CHIREC, Brussels, Belgium

    Patrick Fransen & Frederic Collignon

  3. Service de Neurochirurgie, CHU Tivoli La Louvière, La Louvière, Belgium

    Daniele Morelli

  4. Orthopedic Suite, Woodend Hospital, Aberdeen, UK

    Niall J. A. Craig

  5. Zentrum für Molekulare Orthopädie, Gemeinschaftspraxis Königsallee, Düsseldorf, Germany

    Gregor Godde

  6. Dijlestraat 50, 3110, Rotselaar, Belgium

    Attila Mihalyi

Authors
  1. Jan Van Meirhaeghe
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  2. Patrick Fransen
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  3. Daniele Morelli
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  4. Niall J. A. Craig
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  5. Gregor Godde
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  6. Attila Mihalyi
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  7. Frederic Collignon
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Corresponding author

Correspondence to Jan Van Meirhaeghe.

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Van Meirhaeghe, J., Fransen, P., Morelli, D. et al. Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS® in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. Eur Spine J 21, 2565–2572 (2012). https://doi.org/10.1007/s00586-012-2330-z

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  • DOI: https://doi.org/10.1007/s00586-012-2330-z

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