Journal de la colonne vertébrale

The BACJACTM Interspinous Device in the Treatment of Lumbar Spine Degenerative Disorders: A Prospective Study and 2-Year Follow-Up Results

Abstract

Irace C, Giannachi L, Amato V and Corona C

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
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.