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

A Alexandre ,Mario De Pretto,Andrea Alexandre ,L Corò ,R Saggini

doi:10.1155/2014/176936

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.

Highlights

Degenerative lumbar spinal stenosis (DLSS) is the most common type of spinal stenosis, with a reported incidence of 2–8% in the general population [1]
We present a study of 100 consecutive eligible cases, to assess safety and effectiveness of this interspinous process decompression devices (IPDs) up to 12 months after procedure
All patients were selected on the basis of a history of degenerative lumbar spinal stenosis (DLSS), confirmed by MRI, with symptoms of neurogenic intermittent claudication (NIC), including leg/buttock/groin pain, with or without back pain, relieved by flexion

Summary

Introduction

Degenerative lumbar spinal stenosis (DLSS) is the most common type of spinal stenosis, with a reported incidence of 2–8% in the general population [1]. Due to the increase in life duration DLSS condition becomes symptomatic and is one of the most common causes for spinal surgery in the elderly population over the age of 50. Lumbar extension decreases the cross-sectional area of the dural sac as well as the neural foramina, causing compression on neural and vascular structures, which triggers exacerbation of symptoms [3–5]. While some patients respond well to this treatment, many do not and they become candidates for surgical intervention. Decompressive lumbar laminectomy is the most common surgical procedure, with or without fusion in consideration of coexistence of spinal instability [10–30]

Methods

Results

Conclusion