NCT03178890: OHMG

Osseointegrated Human-Machine Gateway

Status unknown NA Last updated 27 May 2022

What this trial tests

NA trial testing OHMG in Upper Limb Amputation in 18 participants. Status unknown.

Timeline

26 September 2016

Primary endpoint
30 May 2023

30 May 2024

Quick facts

Lead sponsor	Integrum
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	26 September 2016
Primary completion	30 May 2023
Estimated completion	30 May 2024
Sites	1 location across Sweden

Drugs / interventions tested

• OHMG

Conditions studied

• Upper Limb Amputation — all drugs for Upper Limb Amputation →

Sponsor

Integrum

Who can join

Adults 18 to 69, any sex, with Upper Limb Amputation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.