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A Multi-Center, Open-Label, Prospective Study of SpinalStim (MOP-SS) as adjunctive Care following Lumbar Fusion Surgery

Study category: Bones, Muscles, and Joints

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Description

The study will be a prospective, multi-center, non-randomized, single-arm clinical study to evaluate the effectiveness of SpinalStim.

Details
Age

Adult

Eligibility

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.

Phase

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.

Type of Study

Outcomes Research

Location

University of Colorado Hospital

Principal Investigator
Vikas Patel,  MD

Vikas Patel, MD

Study ID

Protocol Number: 17-1037

ClinicalTrials.gov: NCT03176303

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