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. 2014:2014:176936.
doi: 10.1155/2014/176936. Epub 2014 Apr 15.

One-year follow-up of a series of 100 patients treated for lumbar spinal canal stenosis by means of HeliFix interspinous process decompression device

Alberto Alexandre  1 , Andrea Maria Alexandre  2 , Mario De Pretto  1 , Luca Corò  1 , Raul Saggini  3
Affiliations

One-year follow-up of a series of 100 patients treated for lumbar spinal canal stenosis by means of HeliFix interspinous process decompression device

Alberto Alexandre et al. Biomed Res Int. 2014.

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). HeliFix is a minimally invasive IPD that can be implanted percutaneously. This is a preliminary evaluation of safety and effectiveness of this IPD up to 12 months after implantation.

Methods: After percutaneous implantation in 100 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 symptoms and physical function improvements were maintained for up to 12 months. Leg, buttock/groin, and back pain were eased throughout, and the use and strength of related pain medication were reduced. Devices were removed from 2% of patients due to lack of effectiveness.

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

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Figures

Figure 1
Figure 1
The first sharp inserted in the interspinous space is a 5 mm thick trocar (a). After his removal a second trocar bringing on the tip a proof element of 8 mm size is introduced ((b) and (c)). The percutaneous insertion of the IPD is controlled under fluoroscopy (d).
Figure 2
Figure 2
12 months after procedure laterolateral (a) and anteroposterior (b) radiographs are useful to demonstrate the correct position of this L4-L5 implant.
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