Osseointegrated Transtibial Prosthesis With Neural Interface

NAUnknownINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

November 3, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

April 15, 2023

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.

Trial Locations (2)

02115

RECRUITING

Brigham and Women's Hospital, Boston

02139

RECRUITING

MIT Media Lab, Cambridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Brigham and Women's Hospital

OTHER

collaborator

Integrum

INDUSTRY

lead

Massachusetts Institute of Technology

OTHER