Transfemoral Amputee Osseointegration Study (TFAOS)
Technical Report,30 Sep 2017,29 Sep 2018
Henry M. Jackson Foundation Bethesda United States
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This is a 5-year, prospective multisite cohort study, evaluating a device that is FDA approved under a Humanitarian Device Exemption. The study is being conducted at Walter Reed National Military Medical Center and The University of California San Francisco. This non-randomized, longitudinal study will use each study participant as his or her own control, and test the hypothesis that osseointegration results in improvements in the primary and secondary outcomes. In year 1, nineteen patients have been enrolled at WRNMMC. Functional outcomes, and patient reported outcomes continue to be collected as scheduled.
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