Transfemoral Amputee Osseointegration Study (TFAOS)
Abstract
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. As of year 3, there have been 38 patients enrolled at WRNMMC and 6 at the University of California San Francisco. Patient-reported outcomes continue to be collected as scheduled. We are doing our best to collect functional outcomes, although some pandemic-related clinical research restrictions remain in place.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2020
- Accession Number
- AD1130764
Entities
People
- Benjamin K. Potter
- Jonathan Forsberg
- Richard J. O'donnell