Abstract
Background: In the last two decades lumbar interspinous decompression systems have gained a wide and often uncontrolled diffusion. Such devices, usually made of titanium or PEEK (polyetheretherketone), are currently implanted in different lumbar spine degenerative disorders, and clinical indications to their use are often confounding. Methods: This is a single center, single arm, 2-year prospective study of 50 patients undergoing lumbar surgical interspinous decompression, in which the BacJac all-PEEK device was implanted. Preoperative diagnosis was: central (CLS) or foraminal (FLS) spinal stenosis, degenerative antero/retro listhesis<grade I (LAL/RAL), Degenerative Disc Disease (DDD), Recurrent Disc Protrusion (RDP), Lumbar Synovial Cyst (LSC). Clinical and neuroradiological assessment was performed by means of Visual Analog Scale (VAS) plus a novel 3-arm scale (IGEA), Computed Tomography (CT), Magnetic Resonance (MR) and x-rays images. Results: The 2-year follow-up examination was performed in 47 patients (94%); three patients were lost. Thirty- nine out of forty-seven (83%) patients improved, and the remaining eight were considered unchanged. The VAS score improved from 7.5 preoperatively to 3.0 postoperatively; the IGEA-L score improved from 3.0 to 1.7; the IGEA- R score passed from 2.93 to 1.5; the IGEA-Cl improved from 3.5 to 1.5. No major complications were observed; in five cases rupture of a spinous process was observed. Conclusions: Our series is the first prospective study concerning the use of a PEEK interspinous device in the treatment of lumbar spine degenerative disorders. We think the BacJac interspinous spacer, as stand-alone implant or following uni or bilateral decompression, may provide mid-term relief of low-back and radicular pain, as assessed by VAS and IGEA scales, and improvement of neurogenic intermittent claudication, in some lumbar spine degenerative disorders, mainly in central and foraminal stenosis.
Highlights
In the last two decades interspinous devices have gained a wide popularity in lumbar spine surgery
Our series is the first prospective study concerning the use of a PEEK interspinous device in the treatment of lumbar spine degenerative disorders
We here report our experience concerning a series of patients, who received surgical implant of the BacJac Interspinous device for the treatment of some lumbar spine degenerative disorders, aiming to shed a light over features of this device and try delineating welldefined indications for its clinical use
Summary
In the last two decades interspinous devices have gained a wide popularity in lumbar spine surgery. The Wallis implant, made of PEEK (polyetheretherketone) and Dacron bands, was one of the first spacers to be largely used in patients affected by lumbar spinal stenosis, in non-English speaking countries [1]. Basing upon strong research and clinical evidences, the X-STOP device has been recognized as having a role in the surgical treatment of lumbar spinal stenosis causing Neurogenic Intermittent Claudication (NIC), if compared with non-operative therapy and decompressive surgery [3]. In the last two decades lumbar interspinous decompression systems have gained a wide and often uncontrolled diffusion. Such devices, usually made of titanium or PEEK (polyetheretherketone), are currently implanted in different lumbar spine degenerative disorders, and clinical indications to their use are often confounding
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