Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720171
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Integrum

Brief 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.


Condition or disease Intervention/treatment Phase
Amputation Device: e-OPRA Implant System Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, non-randomized, uncontrolled study.
Masking: None (Open Label)
Primary Purpose: Treatment
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 : January 17, 2021
Estimated Study Completion Date : January 17, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A potential subject will be included in the study if she/he meets all of the following inclusion criteria:

  • Male or Female age 22-65 at the time of surgery.
  • The patient must have a medical condition requiring performance of a unilateral transfemoral amputation with a minimum of 13 cm of residual femur after amputation, and:

A: At a minimum level of amputation of 20 cm or greater above the knee joint line if physical therapy and prosthetist evaluation is commensurate with a standard K3 ambulatory status; or, B: At a minimum level of amputation of 16 cm above the knee joint line as part of a single-stage procedure if physical therapy and prosthetist evaluation is commensurate with a more active K3 or less active K4 postoperative ambulatory status.

  • The subject must have undergone independent consultation with at least two lower extremity surgical specialists to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition.
  • The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
  • The patient must have adequate bone stock to support the implanted device.
  • In the opinion of the investigators, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/or study candidate.
  • Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
  • Written informed consent to participate in the study provided by the patient or legal representative.

Exclusion Criteria:

  • Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.
  • Subjects who have not been completely abstinent from tobacco use for at least 6 weeks preoperatively.
  • Active infection or dormant bacteria.
  • Subjects would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
  • Evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, Neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the subject to be a good study candidate.
  • Evidence of any active skin disease involving the proposed surgical limb.
  • History of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.
  • Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).
  • The patient is currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Hugh M Herr, PhD 617-314-3661 hherr@media.mit.edu
Contact: Matthew J Carty, MD 617-983-4555 mcarty@bwh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
MIT Media Lab Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Herr M Herr, PhD         
Sponsors and Collaborators
Integrum
Brigham and Women's Hospital
Massachusetts Institute of Technology
Investigators
Layout table for investigator information
Principal Investigator: Hugh M Herr, PhD Massachusetts Insititute of Technology
Layout table for additonal information
Responsible Party: Integrum
ClinicalTrials.gov Identifier: NCT03720171    
Other Study ID Numbers: IDE G170304
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Integrum:
Osseointegration
Bone-anchored prosthesis
Neuro-prosthesis