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Osseointegrated Transtibial Prosthesis With Neural Interface

NCT05249049 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-02-21

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. 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 transtibial amputee with the e-OPRA Implant System exhibiting full neural control over a neuro-mechanical prosthetic system.

A maximum of two 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 for Transtibial Amputees

The e-OPRA System for transtibial use consists of an anchorage element (Fixture), which is surgically inserted in the medullary canal of the amputated skeleton of the lower limb. The skin penetrating e-Abutment is then inserted and secured with the e-Abutment screw. To allow the system to be used with an external neuro-mechanical prosthesis, soft tissues from the distal limb are preserved incorporated into the residual limb. Muscle electrodes are then placed in the neuro-muscular constructs. After a rehabilitation program, in everyday use, the implanted e-OPRA device will be used by the patient with the Axor TC and their commercially available prosthesis. However, the modified version of the implant will allow the patient to use a powered neuro-mechanical prosthesis during specified testing scenarios.

Sponsors & Collaborators

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
2021-11-03
Primary Completion
2022-12-31
Completion
2023-04-15
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 NCT05249049 on ClinicalTrials.gov