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Acknowledgements: Dr. Ami Stuart, Ph.D., Jacob Smith M.A., Dr. Sarah Turley, Ph.D., and Dr. Toni Roberts, M.D. are acknowledged for their contributions to this research study. Funding was provided by the US Department of Veterans Affairs Rehabilitation Research and Development (RR&D) Service (Grant # 10I1RX0012808-01). The funding agency had no role in study design, analysis, or manuscript preparation.
Conflicts: JP Beck, J. Gililland, J. Agarwal and E. Kubiak provided surgeon consultation services to the device manufacturer during the implant design and study periods. All conflicts of interest were reported and managed by the University of Utah Conflict of Interest committee.
ClinicalTrials.gov Identifier: NCT02720159
Disclosure: This study describes a device limited to investigational use.