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- Title
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.
- Authors
Van Meirhaeghe J; Fransen P; Morelli D; Craig NJ; Godde G; Mihalyi A; Collignon F; Van Meirhaeghe, Jan; Fransen, Patrick; Morelli, Daniele; Craig, Niall J A; Godde, Gregor; Mihalyi, Attila; Collignon, Frederic
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Publication
European Spine Journal, 2012, Vol 21, Issue 12, p2565
- ISSN
0940-6719
- Publication type
journal article
- DOI
10.1007/s00586-012-2330-z