Comparison of disability reduction (Oswestry Disability Index) of the Intralink-Spine Disc Stabilization Device - GENTIS with conventional and emerging treatments for disc related chronic low back pain. Other treatments do not present results at early time-points, presumably due to lack of early efficacy. Competitive data is from peer-reviewed, randomized controlled trials with representative or superior efficacy in their class of treatment.
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Noriega DC, et al., Intervertebral disc repair by allogeneic mesenchymal bone marrow cells - a randomized controlled trial, Transplantation, 2017, 101(8)1945-1951
Fischgrund JS, et al., Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain - a prospective randomized double-blind sham-controlled multi-centered study, Eur Spine J, 2018, 27(5)1146-1156
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Clinical efficacy results based on pain (VAS) and disability (ODI) patient reported outcomes from 2-weeks through 2-years (2-year data for only the first 5 treated patients). These results are from the first 14 treated chronic low back pain patients meeting study inclusion and exclusion criteria. Eighty-six percent (86%) or more of patients demonstrated Good (clinically meaningful reduction of pain or disability or both) or Excellent (50% or greater reductions in pain and disability) results at all time points.