Inter Spinal Fixation and Stabilization Device for Lumbar Radiculopathy and Back Pain

Generally, interspinal distractor fixation devices are used for severe low back pain associated with neurogenic claudication, and radiculopathy with central or lateral recess stenosis and/or foraminal narrowing. In this paper, the authors result in cases of severe low back pain and lumbar radiculopathy in whom this device was used with excellent results.

This is a retrospective study. Patients were contacted via phone call and their pain score and other data were recorded at different timelines. The final data presented in this paper are the data collected at the final follow-up that ranges from 14 months to 24 months. Surgeries were performed in the outpatient setting and although no identifiable patient information is included in this paper, yet, patients were asked for their verbal consent. The patient data are only included if verbal consent was obtained.

Over the past 24 months, 13 patients with disc protrusion and/or central and/or foraminal spinal stenosis were treated with this procedure. Follow-up ranges from 14 months to 24 months with a median of 19 months, male/female ratio of 6/7, and a median age of 68 years. There were no complications or reoperation. Statistical analysis showed significant improvement in the Numeric Pain Rating Scale (NPRS) for back and radicular leg pain (p-value = 0.000552 for back pain and p-value = 0.000291 for radicular leg pain).

The system reported in this paper is a solid fixation system that works both as a distractor and internal decompressor of the spinal canal. It is simple to use and safe. Though the number of patients is small, statistically significant improvement was reported at a median follow-up of 19 months.