A New Interlaminar/Interspinous and Facet-Joint Stabilization System in Lumbar Degenerative Disk Disease: 2 Years of Results.

INTRODUCTION: In lumbar degenerative disk diseases (DDDs), we include a wide range of lumbar pathologies. Lumbar spinal stenosis with or without spondylolisthesis is a common cause of lower-limb pain in elderly patients. The surgical treatment of lumbar DDD consists of the decompression of the neural structures or the decompression and fusion of the involved motion segment. Unfortunately, rigid spinal implants followed by fusion cause increased stresses on the neighboring spinal segments, often leading to adjacent segment degeneration. The aim of this paper is to present a new system for interlaminar/interspinous and facet-joint stabilization and fusion.

MATERIAL AND METHODS: From March 2018 to June 2021, 175 patients with severe lumbar back and/or leg pain were operated on with this device after the failure of conservative treatment for a minimum of 6 months. For this study, we considered 75 available patients with a minimum follow-up time of 24 months. Patients rated their back pain and leg pain on a visual analog scale (VAS) after surgery and at the last follow-up; also, the postoperative consumption of analgesic drugs was investigated. Finally, patients were asked whether they would undergo this kind of surgery again or recommend it. The device is designed to promote a better and more efficient intervertebral fusion: Bone Ingrowth technology allows the system to achieve the best response from the bone tissue.

RESULTS: All procedures were performed without any complications. A reoperation was required in five cases (6.7%) because of implant failure. In one case, a spinous process and unilateral articular process fracture occurred. In four cases, a subcutaneous ISCHIA (one case) or FILICUDI (three cases) pullout was observed. Significant improvements following lumbar surgery were observed when evaluating the postoperative VAS values, analgesic drug consumption levels, and patients' satisfaction ratings. Evident fusion was seen in 58 of 75 patients (77.3%).

CONCLUSIONS: Our interspinous/interlaminar and facet-joint implant solution, associated with bone grafting, provided vertebral fusion in most stenotic patients with Grade I DS undergoing bilateral microdecompression (BMD) or bilateral decompression via the unilateral approach (BDUA). A higher number of patients and a longer follow-up will certainly be required to completely validate these new devices, but this minimally invasive surgery (MIS) is currently very encouraging and satisfactory.