e-OPRA Implant System for Lower Limb Amputees

Status Active, not recruiting

Clinical Trial Summary

The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004. 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 purpose of the study is to evaluate the feasibility of a lower limb amputee with the e-OPRA Implant System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of six subjects will be enrolled. Each subject will undergo a surgery where the e-OPRA Implant System will be implanted. The subjects will participate in follow-up sessions of which the last one occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Amputation

Clinical Trial Details

NCT number	NCT03720171
Study type	Interventional
Source	Integrum
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 17, 2018
Completion date	January 17, 2025

View Details

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