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e-OPRA Implant System for Lower Limb Amputees

NCT03720171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

  • Amputation

Interventions

DEVICE

e-OPRA Implant System

Implantation of e-OPRA Implant System in lower limb to be used with amputation limb prosthesis

Sponsors & Collaborators

Principal Investigators

  • Hugh M Herr, PhD · Massachusetts Insititute of Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2025-03-08
Completion
2025-03-08
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03720171 on ClinicalTrials.gov