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

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

Author information

1
The Orthopaedic and Sports Medicine Center, Trumbull, CT 06611, USA.
2
The Center of Neuromodulation, The University of Kansas Health System, Kansas City, KS 66103, USA.
3
Florida Spine Specialists, Ft. Lauderdale, FL 33308, USA.
4
Jupiter Interventional Pain Management, Jupiter, FL 33477, USA.
5
The Center for Pain Relief, Charleston, WV 25304, USA.
6
Independent Clinical Consultant, San Francisco, CA 94115, USA.

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

Conflict of interest statement

GT reports grants from Vertiflex, during the conduct of the study. DS reports personal fees from Vertiflex, outside the submitted work. KC was paid for time to enroll patients and track data in PRESS registry from Vertiflex, during the conduct of the study. He also received personal fees from Boston Scientific and Vertiflex, outside the submitted work. LJR serves as consultant/instructor for Vertiflex and Boston Scientific. JEB is an independent advisor to Vertiflex and was remunerated for assistance in manuscript development. The authors report no other conflicts of interest in this work.

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