1. Interspinous Process Decompression With The Superion® Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry
- Author
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Dawood Sayed, Jon E Block, Christopher Kim, Kevin D. Cairns, Louis J. Raso, and Gene Tekmyster
- Subjects
medicine.medical_specialty ,Decompression ,business.industry ,Biomedical Engineering ,Medicine (miscellaneous) ,Lumbar spinal stenosis ,030209 endocrinology & metabolism ,Neurogenic claudication ,Perioperative ,medicine.disease ,Responder rate ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,Blood loss ,medicine ,Back pain ,medicine.symptom ,business ,030217 neurology & neurosurgery - 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.
- Published
- 2019
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