Publications by authors named "Alain Fabi"
Study Design: Prospective randomized Food and Drug Administration investigational device exemption clinical trial.
Objective: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device.
Summary Of Background Data: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty.
Objective: The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs.
Methods: Following a successful tonic trial, 100 subjects were randomized to receive one stimulation mode for the first 12 weeks, and then the other stimulation mode for the next 12 weeks. The primary endpoint assessed the noninferiority of the within-subject difference between tonic and burst for the mean daily overall VAS score.
Objective: The EMPOWER™ study evaluated spinal cord stimulation (SCS) safety and efficacy and the associated changes in psychosocial and functional outcomes.
Methods: Upon informed consent and IRB approval, 620 eligible subjects were enrolled prior to SCS trial evaluation and were assessed at baseline, 3, 6 and 12 months post-implant. Patient-reported pain relief (PRP), numerical rating scale (NRS), satisfaction, quality of life (QOL), and pain disability index (PDI) were assessed at all follow-up visits while the pain catastrophizing scale (PCS), short form-36 (SF-36), short form-McGill pain questionnaire version 2 (SF-MPQ-2), and the state-trait anxiety inventory (STAI) were assessed at the 6- and 12-month follow-up visits.