ABSTRACT
PURPOSE: To evaluate safety and efficacy of the novel percutaneous interspinous device (PID) for the treatment of symptomatic degenerative lumbar spinal stenosis (DLSS) in 3 different centers. METHODS: From November 2016 to March 2020, 255 patients (male 125, mean age 71.2 years old range 49-91 years old) with neurogenic claudication, confirmed by electromyography, related to mono or bi-segmental lumbar central canal and/or foraminal stenosis were enrolled in the study. Magnetic resonance (MR) and/or computer tomography (CT), physical exam, and Visual Analogue Scale (VAS) and Zurich Claudication Questionnaire (ZCQ) were performed before and 6 months after the procedure. All treatments were performed under fluoroscopic guidance with local anesthesia and mild sedation. Technical success was defined as correct placement of the Lobster® (Demetrios Medical, Firenze, Italy) PID as demonstrated by computer tomography (CT) performed immediately after treatment; spinoplasty was performed in selected patients. RESULTS: PID placement was accomplished with a 99.6% success rate (257/258). The one device that was not implanted was due to a spinous process fracture. In 28 patients, more than 1 device was implanted in the same session (max 3 PIDs); 6 patients required a second implant in different session. A total of 172 prophylactic spinoplasties were performed (59.3%). No major complications occurred; 3 device misplacements were successfully treated with percutaneous retrieval and new device deployment. 99.6% of patients experienced clinical improvement. CONCLUSION: Lobster PID is an effective and safe minimally invasive decompression method for central canal and neural foraminal stenosis when patients are correctly selected.
Subject(s)
Feasibility Studies , Spinal Stenosis , Humans , Male , Aged , Female , Middle Aged , Aged, 80 and over , Retrospective Studies , Spinal Stenosis/surgery , Spinal Stenosis/diagnostic imaging , Lumbar Vertebrae/surgery , Lumbar Vertebrae/diagnostic imaging , Tomography, X-Ray Computed , Treatment Outcome , Prostheses and Implants , Decompression, Surgical/methodsABSTRACT
PURPOSE: To retrospectively assess safety and potential effectiveness of percutaneous intervertebral disc coagulation therapy (PDCT) using plasma thermal reaction for the treatment of lumbar and cervical disc hernias resistant to medical therapy. MATERIALS AND METHODS: Forty-four patients (age range 18-87 years, mean 52.7) with contained and extruded symptomatic lumbar (N = 48) and cervical (N = 6) disc hernias in the absence of free fragments causing radiculopathy without improvement after 6-week conservative therapy were enrolled. Pretreatment discography has been performed in every patient. Spine MRI was performed before the procedure and 4 months later, in order to check post-PDCT changes. Technical success was defined as correct placement of PDCT fiber; clinical outcomes were evaluated using visual analog scale (VAS) and the Oswestry Disability Index (ODI) before the procedure and after 4 months. RESULTS: A total of 54 levels have been treated with 98% technical success; in 12 patients (27%), the treatment was performed in two levels at the same time. All patients well tolerated the procedure; most patients (N = 39; 89%) had significant improvement in symptoms, with ODI score reduction from 47.61 ± 8.7 to 13.38 ± 9.4 (p < 0.001). The mean pre-PDCT VAS score was 7.47 ± 0.8. VAS score was decreased down to 1.36 ± 1.6 at final follow-up (p < 0.001). There were no cases of infection, nerve damage, or bleeding. CONCLUSIONS: PDCT can be an effective and safe for minimally invasive indirect decompression for cervical and lumbar hernia resistant to conservative treatment, particularly when patients are correctly selected.
