# RR&D Research Career Scientist Award Application

> **NIH VA IK6** · VA SALT LAKE CITY HEALTHCARE SYSTEM · 2020 · —

## Abstract

Patients with amputated limbs are customarily offered socket-based systems, which are stabilized by friction
contact between the socket and the soft tissues of the residual limb. Despite the leading-edge care provided to
patients with amputations by the VA Healthcare System, many abandon their conventional socket-based systems.
In a study of veterans with combat-associated unilateral upper-limb loss, 25% of veterans abandon their socket-
based prosthetics, with rates highest among women. To improve function and quality of life for these patients,
percutaneous osseointegrated (OI) docking systems are being developed worldwide.
The concept of OI is based on the ability of living bone cells to attach to a titanium surface and has been used
for decades to anchor common dental and orthopaedic devices to living bone. My research takes me outside
this paradigm. I engineer percutaneous OI devices, which require a load-bearing metal post to be connected to
the OI endoprosthesis, passing permanently through the skin to be connected to the distal exoprosthetic
componentry outside of the body. To date, the FDA has not approved the broad use of percutaneous OI devices
within the United States. Unfortunately, several OI devices have been experimentally placed into patients by
other groups using either unauthorized copies of European designs or using unproven modifications of devices
off-label. Without FDA approval, the broad commercial introduction of percutaneous OI technology is limited in
all healthcare systems.
The overarching goal of my research is to maximize the functional recovery and the quality of life of US Veterans
with limb loss. To achieve this, we need to bring safe, FDA approved percutaneous OI devices to this deserving
patient population. Since 2006, I have led the engineering efforts of a multidisciplinary team that uses a data-driven
approach to engineer percutaneous OI devices for amputees. We have followed a strict scientific approach with
the goal of achieving FDA approval for use throughout the United States. My pre-clinical work ranged from basic
bench-top science to numerous animal model trials, investigating basic principles of not only skeletal fixation, but
also infection prevention at the stoma created as the percutaneous post passes through the skin. With these pre-
clinical findings, we designed and manufactured a series of transfemoral percutaneous OI devices, we established
the initial surgical procedures, manufactured appropriate surgical instrumentation, tested the initial biomechanical
stability, and established the static mechanics and fatigue properties of the device. This pre-clinical work culminated
in approval of the first FDA directed Early Feasibility Study (EFS) of a percutaneous OI device in a population of 10
veterans with transfemoral amputations. Information obtained via the transfemoral EFS is now being used to
transition to a multicenter pivotal clinical trial for FDA approval and wide-range clinical adoption.
...

## Key facts

- **NIH application ID:** 9941280
- **Project number:** 1IK6RX003071-01A1
- **Recipient organization:** VA SALT LAKE CITY HEALTHCARE SYSTEM
- **Principal Investigator:** Kent N. Bachus
- **Activity code:** IK6 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2020-01-01 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9941280

## Citation

> US National Institutes of Health, RePORTER application 9941280, RR&D Research Career Scientist Award Application (1IK6RX003071-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9941280. Licensed CC0.

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