Medical Devices: Evidence and Research (Oct 2019)
Interspinous Process Decompression With The Superion® Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry
Abstract
Gene Tekmyster,1 Dawood Sayed,2 Kevin D Cairns,3 Louis J Raso,4 Christopher Kim,5 Jon E Block6 1The Orthopaedic and Sports Medicine Center, Trumbull, CT 06611, USA; 2The Center of Neuromodulation, The University of Kansas Health System, Kansas City, KS 66103, USA; 3Florida Spine Specialists, Ft. Lauderdale, FL 33308, USA; 4Jupiter Interventional Pain Management, Jupiter, FL 33477, USA; 5The Center for Pain Relief, Charleston, WV 25304, USA; 6Independent Clinical Consultant, San Francisco, CA 94115, USACorrespondence: Jon E Block 2210 Jackson Street, Ste. 401, San Francisco, CA 94115, USATel +1 415 775 7947Email [email protected]: 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®, interspinous spacer, lumbar spinal stenosis, neurogenic claudication, decompression
