Interspinous Process Decompression With The Superion ® Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry

Med Devices (Auckl). 2019 Oct 3;12:423-427. doi: 10.2147/MDER.S220431. eCollection 2019.

Abstract

Background: Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis (LSS).

Methods: IPD used the Superion® Indirect Decompression System (Vertiflex, Carlsbad, CA, USA). Perioperative and clinical data were captured via a registry for patients treated with IPD for LSS with intermittent neurogenic claudication. Three-hundred sixteen physicians at 86 clinical sites in the US participated. Patient data were captured from in-person interviews and a phone survey. Outcomes included intraoperative blood loss, procedural time, leg and back pain severity (100 mm VAS), patient satisfaction and treatment approval at 3 weeks, 6 and 12 months.

Results: The mean age of registry patients was 73.0 ± 9.1 years of which 54% were female. Mean leg pain severity decreased from 76.6 ± 22.4 mm preoperatively to 30.4 ± 34.6 mm at 12 months, reflecting an overall 60% improvement. Corresponding responder rates were 64% (484 of 751), 72% (1,097 of 1,523) and 75% (317 of 423) at 3 weeks, 6 and 12 months, respectively. Back pain severity improved from 76.8 ± 22.2 mm preoperatively to 39.9 ± 32.3 mm at 12 months (48% improvement); 12-month responder rate of 67% (297 of 441). For patient satisfaction at 3 weeks, 6 and 12 months, 89%, 80%, and 80% were satisfied or somewhat satisfied with their treatment and 90%, 75%, and 75% would definitely or probably undergo the same treatment again. In the phone survey, the rate of revision was 3.6% (51 of 1,426).

Conclusion: These registry findings support the clinical adoption of minimally invasive IPD in patients with neurogenic claudication associated with LSS.

Keywords: Superion®; decompression; interspinous spacer; lumbar spinal stenosis; neurogenic claudication.