# Functional Expectations of Transhumeral Percutaneous Osseointegration Patients.

> **NIH VA I01** · VA SALT LAKE CITY HEALTHCARE SYSTEM · 2022 · —

## Abstract

An FDA Early Feasibility Study (EFS) allows “for early clinical evaluation of devices to provide proof of principle
and initial clinical safety data.” Over the past four years, our team has performed the first EFS clinical trial of a
percutaneous osseointegrated (OI) docking system for patients with transfemoral amputations. As of
December 1, 2017, 10 transfemoral VA patients received the device and are ambulating successfully for up to
22-months with positive safety and functional results. Currently, the EFS safety and functionality data are being
used to target a pivotal study of the transfemoral device to obtain Premarket Approval (PMA) that will result in
the broad clinical introduction of the transfemoral OI device within the US. However, transhumeral patients are
currently underserved by prosthetic technologies. Nearly 60% of transhumeral patients limit their use of
suspension-based prostheses and upwards of 30% of upper-limb suspension-type prosthetic devices are
completely abandoned by both the VA and the military patient populations—with abandonment of the
prosthesis most common among women. The overarching goal of this proposal is to maximize the functional
recovery of US veteran, military, and civilian patients with transhumeral limb loss. We believe that this can be
done by bringing FDA approved percutaneous OI devices to this patient population. Over the past 3 years, we
developed a unique percutaneous OI device, known here as PODS, specifically for transhumeral patients
using an evidence based approach.
The Primary Aim of this proposal is to perform an FDA guided EFS of the PODS device for transhumeral
patients, establishing its initial clinical safety. An initial group (N=20) of transhumeral patients will be recruited
to the Salt Lake City (SLC) VA for in-depth consultation and patient centered functional evaluation using a
shared decision making approach. Recruited candidates will undergo a full clinical evaluation of the residual
limb. Functional assessments, focusing on activities of daily living (ADL), and evaluation of joint and terminal
device biomechanics will be collected with their socket-prosthetic device (time = 0). These data will be used for
final patient selection (N=10) for inclusion in the FDA EFS clinical trial. The EFS patients will be brought back
to the SLC VA, admitted to the hospital, and have the Stage 1 surgery to receive the PODS endoprosthetic
device, and then discharged to home. Approximately 4 weeks later, patients will return to the SLC VA and have
the Stage 2 procedure performed to place the percutaneous post and attach their prosthetic device. Post-
operatively, wound healing will be monitored at the percutaneous site. Patients will be discharged from the
hospital to continue outpatient rehabilitation. Periodically (time = 3, 6, and 12 months) following the Stage 2
procedure, patients will be brought back to the SLC VA for assessment of their residual bone, soft tissues and
device. The patient centere...

## Key facts

- **NIH application ID:** 10475095
- **Project number:** 5I01RX002935-05
- **Recipient organization:** VA SALT LAKE CITY HEALTHCARE SYSTEM
- **Principal Investigator:** Kent N. Bachus
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2022
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2018-10-01 → 2024-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10475095

## Citation

> US National Institutes of Health, RePORTER application 10475095, Functional Expectations of Transhumeral Percutaneous Osseointegration Patients. (5I01RX002935-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10475095. Licensed CC0.

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