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

NAActive, not recruitingINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

May 2, 2026

Study Completion Date

May 2, 2027

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."

Trial Locations (2)

02115

Brigham and Women's Hospital, Boston

02139

MIT Media Lab, Cambridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Massachusetts Institute of Technology (MIT)

UNKNOWN

collaborator

Integrum

INDUSTRY

lead

Brigham and Women's Hospital

OTHER