Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS® in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication

Abstract

Purpose New interspinous process decompression devices (IPDs) provide an alternative to conservative treatment and decompressive surgery for patients with neurogenic intermittent claudication (NIC) due to degenerative lumbar spinal stenosis (DLSS). APERIUS Ò is a minimally invasive IPD that can be implanted percutaneously. This multicentre prospective study was designed to make a preliminary evaluation of safety and effectiveness of this IPD up to 12 months post-implantation. Methods After percutaneous implantation in 156 patients with NIC due to DLSS, data on symptoms, quality of life, pain, and use of pain medication were obtained for up to 12 months.Results Early symptom and physical function improvements were maintained for up to 12 months, when 60 and 58 % of patients maintained an improvement higher than the Minimum Clinically Important Difference for Zurich Claudication Questionnaire (ZCQ) symptom severity and physical function, respectively. Leg, buttock/groin, and back pain were eased throughout, and the use and strength of related pain medication were reduced. Devices were removed from 9 % of patients due to complications or lack of effectiveness. Conclusions Overall, in a period of up to 12 months follow-up, the safety and effectiveness of the APERIUS Ò offered a minimally invasive option for the relief of NIC complaints in a high proportion of patients. Further studies are underway to provide insight on outcomes and effectiveness compared to other decompression methods, and to develop guidance on optimal patient selection.

Midterm Clinical and Radiologic Outcomes after Percutaneous Interspinous Spacer Treatment for Neurogenic Intermittent Claudication

“…Another study reported durable reductions in VAS score and quality-of-life measures to 12 months (16); similar reductions in VAS and ODI scores were reported in a smaller retrospectively studied cohort of 37 patients at mean 18-month follow-up (17). Our study adds to the existing literature by providing data for durable reduction in VAS and ODI scores in a cohort of Note-Data are presented as number (%) or mean Ϯ SD.…”

Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life

“…In 128 patients with a complete 12 months of follow-up, symptom severity according to ZCQ decreased by 26.7 ± 25.8 %, and physical function by 25.3 ± 27.7 %. 58 serious adverse events and twelve serious adverse device-related effects were reported [24]. However, statistical weaknesses of the study as well as conflict of interest should be considered when evaluating his positive conclusion.…”

Failure rates and complications of interspinous process decompression devices: a European multicenter study

“…In a prospective multicenter study on the safety and effectiveness of the Aperius IPD, 14 (9%) patients had their device removed during the 12-month postprocedural period because of persistent or recurring symptoms (10 cases), spinous process fracture (3 cases), or malpositioning (1 case). 46 In our study, 67 devices were implanted percutaneously. Of these, 3 were removed because of malpositioning, 1 because of spinous fracture, and 5 because of neurological worsening.…”