e-OPRA Implant System for Lower Limb Amputees
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03720171|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2018
Last Update Posted : May 25, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Amputation||Device: e-OPRA Implant System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, non-randomized, uncontrolled study.|
|Masking:||None (Open Label)|
|Official Title:||An Osseointegrated Transfemoral Prosthesis Study Evaluating Stable Neural Signal Transmission in Patients With Transfemoral Amputations|
|Actual Study Start Date :||January 17, 2018|
|Estimated Primary Completion Date :||May 26, 2023|
|Estimated Study Completion Date :||January 17, 2025|
Experimental: e-OPRA Implant System
Implantation of e-OPRA Implant System in lower limb.
Device: e-OPRA Implant System
Implantation of e-OPRA Implant System in lower limb to be used with amputation limb prosthesis
- Electrode function [ Time Frame: 24 months ]
i) To evaluate implantation robustness, and connector/lead integrity:
i.a. Measured Impedance (kOhms)
i.b. Maximal Voluntary Contraction (MVC) Amplitude (mV)
ii) To evaluate sensor function and signal quality:
ii.a. Signal-to-noise ratio (SNR) above 2
- Preferred walking speed [ Time Frame: 24 months ]Preferred walking speed, as each subject ambulates with the neuromechanical prosthesis, will be evaluated. Preferred walking speed will be compared to a non-amputee height/weight match for each enrolled subject. A baseline data set will first be collected for each subject ambulating with a conventional prosthesis. Each subject will be timed as they traverse a predetermined distance at a steady speed that they deem most comfortable.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720171
|United States, Massachusetts|
|MIT Media Lab|
|Cambridge, Massachusetts, United States, 02139|
|Principal Investigator:||Hugh M Herr, PhD||Massachusetts Insititute of Technology|