# Pre-Clinical Development of an Instrumented Trapezium Carpal Bone

> **NIH NIH R21** · RHODE ISLAND HOSPITAL · 2021 · $137,429

## Abstract

The goal of this R21 proposal is to complete the preclinical development and evaluation of an instrumented
replacement trapezium (iTrapz) capable of measuring joint contact loads at the base of the thumb, establishing
the rigor for a future clinical trial in trapezial arthroplasty. The numerous surgical treatments for late-stage
osteoarthritis (OA) of the thumb carpometacarpal (CMC) – or trapeziometacarpal (TMC) – joint, are highly varied
and suboptimal. TMC OA is a degenerative disease that results in significant impairment due to pain and loss of
function. The prevalence of TMC OA is at least 20-25% in those over 50, and it increases into the eighth decade
when as many as 80% have evidence of disease. High forces in the trapeziometacarpal joint are believed to
influence OA development and treatment success. However, our understanding of joint loads developed in the
hand is limited to predictions from mathematical models that have yet to be validated by in vivo measurements.
Custom implants instrumented to measure joint contact loads have been developed for the hip, knee, and spine.
Data from these implants has provided critical insight into joint function, with the tangible direct benefits of
validating and improving musculoskeletal models and providing important information for implant designers and
manufacturers. Instrumented implants also have the potential to provide highly novel biofeedback to patients to
guide rehabilitation. Building on our extensive and rigorous in vivo studies of TMC morphology and kinematics,
and the records of success in other instrumented joints, we propose to develop and validate a preclinical
instrumented trapezium implant, which we refer to as the iTrapz. In our first aim we will design, fabricate and
validate a proof-of-concept wired iTrapz. In Aim 2 we will validate the wired iTrapz in a cadaver model using a
robotic musculoskeletal simulator. Once we complete these aims we will have a highly innovative load sensor
suitable for cadaver studies. Given the need for more rigorous studies of thumb arthroplasties, this
accomplishment alone will have a significant impact. In Aim 3 we will develop a first-prototype inductively
powered and telemeterized iTrapz implant. In Aim 3 we will also begin planning for in vivo implementation in a
clinical study. Upon completion of Aim 3 we will have demonstrated that measuring in vivo thumb loads during
the activities of daily living is feasible, and we will have developed the necessary knowledge, skills and
technologies to support the fabrication of a hermetically sealed implant suitable for clinical implementation. This
project is significant in that it will benefit several constituencies: clinicians will benefit from the knowledge of the
loads associated with disease, injury, surgery and repair; the modeling and research communities will benefit
directly from measurements of joint loads during activities of daily living, which are unknown in the hand; and
engineers and manufa...

## Key facts

- **NIH application ID:** 10132242
- **Project number:** 5R21AR077201-02
- **Recipient organization:** RHODE ISLAND HOSPITAL
- **Principal Investigator:** Joseph J Crisco
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $137,429
- **Award type:** 5
- **Project period:** 2020-04-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10132242

## Citation

> US National Institutes of Health, RePORTER application 10132242, Pre-Clinical Development of an Instrumented Trapezium Carpal Bone (5R21AR077201-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10132242. Licensed CC0.

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