Osseointegrated Human-Machine Gateway

Summary

Advanced prosthetic devices are currently controlled by electromyography (EMG) signals generated by patient's stump muscles and recorded by surface electrodes attached on the skin. This way of recordings is often unreliable, inconsistent and leading to high prosthetic abandonment rates for individuals with upper limb amputation. The use of implantable electrodes has been long thought as the solution for a more natural control of artificial limbs, as these offer access to long-term stable and physiologically appropriate sources of control, as well as the possibility to elicit appropriate sensory feedback via neurostimulation.

This Clinical Investigation (CI) is performed to clinically test and verify the safety and benefits of 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 artificial limbs. The bidirectional interface is based, and requires, the clinically established implant system for bone-anchored prostheses named Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA). The feasibility of the device was initially proven through a proof-on-concept patient who has used the system without any adverse events for more than three years.

This CI is performed to verify the safety and benefits of the Osseointegrated Human Machine Gateway (OHMG) as an enhancement of the OPRA Implant System for patients with upper limb amputation, when used within the intended purpose and according to instructions. The CI will be performed at Sahlgrenska University Hospital and Chalmers University of Technology, Sweden. A maximum of eighteen patients will be enrolled. Each patient will undergo a surgery where the OHMG will be implanted. The patients will participate in 8 follow-up sessions, the last one approximately 13 months after the surgery. The study is prospective, where the patient is his/her own control.

Conditions

• Upper Limb Amputation

Interventions

DEVICE

OHMG

Device will be implanted in all enrolled patients.

Sponsors & Collaborators

• Sahlgrenska University Hospital

  collaborator OTHER

• Chalmers University of Technology

  collaborator OTHER

• Vinnova

  collaborator OTHER_GOV

• Promobilia Foundation

  collaborator OTHER

• The Swedish Research Council

  collaborator OTHER_GOV

• Integrum

  lead INDUSTRY

Principal Investigators

• Paolo Sassu, MD · Sahlgrenska University Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-26

Primary Completion

2023-05-30

Completion

2024-05-30

Countries

• Sweden

Study Locations