The study will be a prospective, multi-center, non-randomized, single-arm clinical study to evaluate the effectiveness of SpinalStim.
Male or Female subjects 18 years and older requiring a lumbar fusion surgery with one or more of the following risk factors for non-fusion: currently using nicotine, multi-level fusion, prior failed fusion at any lumbar level, diabetes, osteoporosis.
Detailed Eligibility: Exclusion criteria: BMI 45 or greater, scoliosis greater than 30 degrees, current substance abuse, active malignancy or within the past 5 years, prisoner.
IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.
University of Colorado Hospital
Vikas Patel, MD
Protocol Number: 17-1037
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