MedTrace Logo

An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations

NCT03957226 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-10-04

No results posted yet for this study

Summary

This early feasibility study proposes to evaluate use of the electronic-Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) device, a transhumeral implant system for direct skeletal anchorage of amputation prostheses, with a test prosthesis. The e-OPRA System is being investigated to better understand the ability to improve the functionality of the prosthesis and enhance the sense of embodiment of the prosthesis itself. This will be a 10 subject Early Feasibility Study in which the primary objective is to capture preliminary safety and effectiveness information on the implanted e-OPRA system. With the addition of electrodes to the muscle segments, this biological interface allows for both the extraction of fine motor control signals from the nerve fascicles and the generation of sensory percepts via electrical stimulation of the muscles. In addition, electrodes placed on muscles within the residuum with native vascularization and innervation also allow the extraction of critical motor control signals and the generation of sensory feedback through muscle stimulation. The electrical activity recorded from these muscle segments (called electromyography or EMG) is specific to certain movements and can be used to determine precisely how a person wants to move their arm and hand. Use of the e-OPRA device with the well-documented neuro-electronic capabilities of EMG control systems provides an alternative to traditional socket prostheses by establishing a direct, loadbearing link between the patient's skeleton and prosthesis.

Conditions

  • Amputation Neuroma
  • Amputation
  • Prosthesis User

Interventions

DEVICE

e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)

The e-OPRA is an implant system that provides an alternative to traditional socket prostheses by establishing a direct, load-bearing link between the patient's skeleton and a prosthesis for transhumeral amputees. The anchorage element of the system is implanted directly into the bone while the electrodes that provide control signals for the prosthesis are implanted into muscle grafts on the transhumeral amputation.

Sponsors & Collaborators

Principal Investigators

  • Paul Cederna, MD · University of Michigan, Section of Plastic Surgery

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
2020-01-30
Primary Completion
2022-06-23
Completion
2022-06-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03957226 on ClinicalTrials.gov