# Screening of Above Elbow Amputees for Advanced Prosthetic Devices

> **NIH VA I01** · VA SALT LAKE CITY HEALTHCARE SYSTEM · 2020 · —

## Abstract

RELEVANCE: This study will create a database of the above elbow amputee population being treated within
the VA hospital system and a patient classification system for use in the research and development of new
prosthetic technologies. This work aims to collect anatomical, quality of life and biomechanical data that will be
used to optimize the design of an above-elbow osseointegrated implant being developed to improve the quality
of life for Veterans amputees. Dr. Sarina Sinclair and her collaborators have the clinical and research
foundation on which to successfully complete this work.
 Direct skeletal attachment of prosthetic limbs through osseointegration (OI), is currently being tested and
optimized at the George E. Wahlen VA Salt Lake City Health Care System. OI technology is being developed
to improve prosthetic attachment, improve functional outcomes and reduce complications commonly
associated with socket interface systems. Our research team is currently conducting an FDA approved Early
Feasibility Study of an OI prosthesis in veteran transfemoral amputees. The knowledge gained from our
successful transfemoral OI program is now being applied to upper extremity amputees. It is our goal to offer
transhumeral (TH) amputees an OI system that will enable them to take full advantage of the advanced upper
extremity prosthetic technologies that have been developed in recent years to maximize function. This study on
TH amputees will be the first to gather comprehensive anatomical, quality of life and functional data that will be
used to develop a classification system to identify candidates for future clinical trials.
AIMS: Aim 1) Create a database of US Veterans with transhumeral amputations for use in the development of
prosthetic technologies through a chart review, clinical referrals and personal interviews; Aim 2) Conduct a full
clinical evaluation of upper extremity bone and soft tissue anatomy via physical exam, gross anatomical
measurements, X-rays, DEXA and CT scans; Aim 3) Assess the functional capabilities of TH amputees being
treated within the VA system utilizing validated tools for monitoring range of motion, biomechanics, activity,
impairment and patient satisfaction; Aim 4) Develop a patient classification system of TH amputees that can be
used to identify appropriate candidates for clinical trials of prosthetic technologies.
METHODS: A national search will be conducted for veteran above elbow amputees. Medical records will be
reviewed to gather demographic and epidemiologic data including: cause, time since amputation, residual limb
length, prosthetic use and comorbidities. Patients that meet a predetermined set of inclusion criteria will be
sent a letter informing them of the study and requesting a response if they have interest in OI technologies. If
consented to attend a screening visit, participants will undergo the following assessments: Anterior/Posterior
and Lateral X-rays, Computed Tomography (CT) scan, DEXA scan, Physical...

## Key facts

- **NIH application ID:** 9980716
- **Project number:** 5I01RX002513-03
- **Recipient organization:** VA SALT LAKE CITY HEALTHCARE SYSTEM
- **Principal Investigator:** Sarina Kay Sinclair
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2018-09-01 → 2022-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9980716

## Citation

> US National Institutes of Health, RePORTER application 9980716, Screening of Above Elbow Amputees for Advanced Prosthetic Devices (5I01RX002513-03). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9980716. Licensed CC0.

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