Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees

Summary

The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb. The Magnetic Bead Tracking System, which will be implanted and used in combination with the e-OPRA Implant system, is an investigational device that consists of pairs of magnetic beads, and a set of magnetic field sensors that measure and track the length of muscles and the speed at which they move in real-time. When the beads are implanted in muscle in the residual limb of an amputee, the muscle length signal is communicated to an investigational, robotic ankle-foot prosthesis. The purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System and Magnetic Bead Tracking System exhibiting full neural control over a neuro-mechanical prosthetic system.

A maximum of seven subjects will be enrolled. Each subject will undergo one or more surgeries where the e-OPRA Implant System and Magnetic Bead Tracking System will be implanted. The subjects will participate in follow-up sessions the last of which occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.

Conditions

• Amputation

Interventions

DEVICE

eOPRA Implant System for Transtibial Amputees and Magnetic Bead Tracking System

The Magnetic Bead Tracking System is an investigational device that consists of pairs of magnetic beads, and a set of magnetic field sensors that measure and track the length of muscles and the speed at which they move in real-time. When the beads are implanted in muscle in the residual limb of an amputee, the muscle length signal is communicated to an investigational, robotic ankle-foot prosthesis. The e-OPRA is an investigational implant system that lets a lower leg prosthesis attach securely to the remaining tibia bone. The e-OPRA device has been designed so that it can be implanted with an electrode set that consists of an electrical connector and electrodes to allow it to be used with both a neuro-mechanical (powered) prosthesis system, in addition to the standard prosthesis. The operation to implant these devices will represent a modification of the surgical technique currently employed for standard below knee amputation.

Sponsors & Collaborators

• Massachusetts Institute of Technology (MIT)

  collaborator UNKNOWN

• Integrum

  collaborator INDUSTRY

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Matthew J Carty, MD · Brigham and Women's Hospital

• Hugh Herr, PhD · Massachusetts Institute of Technology

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

22 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2026-05-02

Completion

2027-05-02

FDA Device

Yes

Countries

• United States

Study Locations